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Teduglutide

Tier 1 · Human trials
Also known as Gattex · Revestive · ALX-0600

Supported by human randomized controlled trials (pivotal phase III studies CL0600-020, pediatric RCTs, Japanese phase III trials), human observational/real-world data and pharmacokinetic studies, plus mechanistic/expert-opinion reviews. Neoplasia/hyperplasia potential is based on animal carcinogenicity data (Tier 2), and mucositis/IBD uses are theoretical (Tier 4), but the strongest evidence present is Tier 1 human RCT for the approved short bowel syndrome indication.

Half-life
~1.47 h
Routes
Subcutaneous injection
Goals
Short bowel syndrome / intestinal failure · Intestinal rehabilitation and adaptation · Reduction/weaning of parenteral nutrition
Cost / mg
Not recorded

How it works

Teduglutide is a lab-made, longer-lasting copy of a natural gut hormone called GLP-2. Like the natural hormone, it tells the cells lining the intestine to grow, repair themselves and resist dying off. This makes the intestinal surface healthier and better able to absorb fluids and nutrients. It also slows how fast the stomach empties, reduces excess stomach acid, and boosts blood flow to the gut. In people with short bowel syndrome — who have lost a lot of functional intestine — these effects help the remaining bowel absorb more, so they need less nutrition delivered through an IV (parenteral support).

Overview

Overview

Teduglutide (brand names Gattex in the US and Revestive in Europe; development code ALX-0600) is a 33-amino-acid recombinant analog of human glucagon-like peptide-2 (GLP-2), produced in Escherichia coli by recombinant DNA technology. GLP-2 is a naturally occurring nutrient peptide hormone derived from proglucagon and secreted by L-type endocrine cells located primarily in the distal small intestine and colon. Teduglutide was engineered to have a longer half-life than native GLP-2, making it suitable as a long-term therapy.

Mechanism and biological role

Teduglutide regulates the functional and structural integrity of the cells lining the gastrointestinal tract. Acting as a GLP-2 receptor agonist, it induces proliferation of intestinal crypt cells, inhibits apoptosis of intestinal epithelial cells, promotes repair of damaged intestinal mucosa, enhances intestinal blood supply, inhibits gastric acid secretion, delays gastric peristalsis, and regulates mucosal barrier function. Collectively these actions improve structural and functional intestinal adaptation following intestinal resection and increase absorption of fluid and nutrients. Unlike GLP-1 — which increases postprandial insulin, inhibits glucagon secretion and slows gastric emptying — GLP-2 primarily increases growth of the intestinal epithelium and maintains mucosal morphology and function, with limited effect on insulin secretion or glucose homeostasis and no decrease in pancreatic glucagon secretion.

Clinical use

Teduglutide is the first GLP-2 analogue and the first long-term medical therapy approved for treatment of adult patients with short bowel syndrome (SBS) who are dependent on parenteral support. SBS is a rare, potentially life-threatening malabsorptive condition caused by significant loss of functional or physical bowel mass (from resection, congenital defect, or disease) and is the most common cause of chronic intestinal failure (~75% of adult and ~50% of pediatric cases). ALX-0600 received FDA Orphan Drug designation in August 1999, with a phase II pilot trial beginning that year. Teduglutide was subsequently approved by both the US FDA and the European Medicines Agency. Approved minimum age varies across labels: EU (Revestive) and drugs.com describe use from age 1 year and above, US Gattex for adults and pediatric patients ≥1 year, while the Teduglutide Viatris EU label extends the indication to patients 4 months corrected gestational age and above.

Evidence

Efficacy is supported by human RCTs. A 3-week phase 2 metabolic balance study showed teduglutide increased intestinal wet weight absorption by ~700 g/day and reduced fecal energy losses by ~0.8 MJ/day (~200 kcal/day). Two 24-week phase III placebo-controlled studies demonstrated beneficial fluid composite effects and reduced need for parenteral support. In the pivotal double-blind phase III study (CL0600-020), a significantly greater proportion of teduglutide 0.05 mg/kg/day recipients than placebo achieved at least a 20% reduction from baseline in weekly parenteral support volume at week 20 maintained to week 24. Across the clinical program, 623 unique subjects received teduglutide and 198 received placebo. Pediatric phase III results were consistent with adults, and Japanese phase III trials confirmed efficacy and safety. Real-world observational data confirm effectiveness and safety, with heterogeneous response that increases progressively up to 2 years (reaching 82% in some series); presence of colon in continuity is a negative predictor of early response but a positive predictor for withdrawal of home parenteral nutrition.

Practical considerations

Treatment should be initiated under supervision of a professional experienced in SBS treatment and only after the patient is stable following intestinal adaptation. The AGA clinical practice update recommends teduglutide only in carefully selected patients after optimization of diet and conventional treatments, given significant adverse effects and cost. Treatment effect should be evaluated after 6 months in adults and after 12 weeks in pediatric patients; some patients (e.g., those with colon-in-continuity or distal/terminal ileum) may take longer to respond, and if no overall improvement is achieved after 12 months, continued treatment should be reconsidered. Following successful elimination of parenteral support, patients require long-term monitoring for nutritional deficiencies. ALX-0600 was also theorized to have potential for chemotherapy-associated mucositis and inflammatory bowel disease, but these remain theoretical.

What the research shows

173 findings extracted from the 29 sources cited below, strongest evidence first within each group. Every one links to the source it came from.

What human studies found

Based on 37 human trial findings, 12 human study findings and 4 expert opinion findings.

  • human trialTeduglutide 4 mg/day for 10 days does not affect gastric emptying of liquids in healthy subjects as measured by acetaminophen pharmacokinetics1

  • human trialTeduglutide is efficacious and safe in adult Japanese patients with short bowel syndrome and intestinal failure3

  • human trialTeduglutide has been demonstrated to facilitate the absorption of gut nutrient and lessen the need for parenteral assistance in patients with Short Bowel Syndrome (SBS)4

  • human trialSafety and clinical efficacy of REVESTIVE in adult patients with Short Bowel Syndrome is derived from 2 randomised placebo-controlled trials7

  • human trialIn adult and pediatric studies teduglutide was evaluated8

  • human trialIf no overall improvement is achieved after 12 months, the need for continued treatment should be assessed9

  • human trialNo clinically significant differences in safety and efficacy were observed between subjects younger than 65 years and those older than 65 years9

  • human trialTreatment effect should be evaluated after 6 months11

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  • human trialSome patients may take longer to respond to treatment (i.e., those who still have presence of colon-in-continuity or distal/terminal ileum); if no overall improvement is achieved after 12 months, the need for continued treatment should be reconsidered11

  • human trialLimited data from clinical studies have shown that some patients may take longer to respond to treatment11

  • human trialThere are no data available in paediatric patients after 6 months11

  • human trialIn a 3-week, phase II balance study, teduglutide reduced diarrhea by around 700 g/day14

  • human trialIn a 3-week, phase II balance study, teduglutide reduced fecal energy losses by around 0.8 MJ/day14

  • human trialIn two randomized, placebo-controlled, 24-week, phase III studies, teduglutide showed beneficial effects on fluid composite effect (reduction in need for parenteral support, increase in urine production and reduction in oral fluid intake)14

  • human trialTeduglutide treatment at 0.05 mg/kg/day reduces parenteral support requirements by ≥20% from baseline in 57.1% of infants (4/7) after 24 weeks17

  • human trialTeduglutide treatment at 0.05 mg/kg/day reduces parenteral support requirements by ≥20% from baseline in 66.7% of children (4/6) after 24 weeks17

  • human trialStandard of care reduced parenteral support requirements by ≥20% from baseline in 50.0% of infants (2/4)17

  • human trialOne infant (50.0%) maintained ≥20% reduction in parenteral support at 48 weeks of teduglutide treatment17

  • human trialFour children (80.0%) maintained ≥20% reduction in parenteral support at 48 weeks of teduglutide treatment17

  • human trialTwo children receiving teduglutide achieved enteral autonomy, one after 12 weeks and one after 28 weeks of treatment17

  • human trialIn a phase III trial in adults with SBS intestinal failure dependent on parenteral support, a significantly greater proportion of teduglutide 0.05 mg/kg/day than placebo recipients achieved a ≥20% reduction in weekly PS volume from baseline to week 20 and maintained it to week 2420

  • human trialThe proportion of patients who had a reduction in one or more days on PS was also significant with teduglutide compared with placebo20

  • human trialImproved intestinal absorption and reduced PS requirements were generally maintained in the longer term20

  • human trialResults from a phase III trial in paediatric patients with SBS-IF dependent on PS were consistent with those in adults20

  • human trialIn a 3-week, phase 2, metabolic balance study, teduglutide increased intestinal wet weight absorption by approximately 700 g/day21

  • human trialIn a 3-week, phase 2, metabolic balance study, teduglutide reduced fecal energy losses by approximately 0.8 MJ/day (∼200 Kcal/day)21

  • human trialIn two subsequent 24-week, phase 3 studies, teduglutide reduced the need for parenteral support21

  • human trialIn a 3-week, phase 2, metabolic balance study, teduglutide increased intestinal wet weight absorption by approximately 700 g/day22

  • human trialIn a 3-week, phase 2, metabolic balance study, teduglutide reduced fecal energy losses by approximately 0.8 MJ/day22

  • human trialIn two subsequent 24-week, phase 3 studies, teduglutide reduced the need for parenteral support22

  • human trialIn a pivotal, double-blind, multicentre, phase III study, a significantly higher proportion of teduglutide 0.05 mg/kg/day recipients than placebo recipients achieved at least a 20% reduction from baseline in weekly parenteral support volume at week 20 and maintained at week 2423

  • human trialThe overall mean reduction in weekly parenteral support volume from baseline was greater in patients who received teduglutide compared with those who received placebo23

  • human trialMore teduglutide-treated patients achieved at least a one-day reduction in parenteral support than those receiving placebo23

  • human trialTeduglutide improves intestinal absorption of fluid and nutrients in Short Bowel Syndrome patients25

  • human trialA total of 623 unique subjects received at least one dose of teduglutide and 198 subjects treated with placebo in the clinical program25

  • human trialThe pivotal study (CL0600-020) was a double blind, placebo-controlled study comparing 0.05 mg/kg/day of teduglutide to placebo25

  • human trialA supportive double-blind, placebo-controlled study (CL0600-004) compared two dose levels, 0.05 mg/kg/day and 0.10 mg/kg/day, of teduglutide to placebo25

  • human studyPrevious studies assessing the effect of GLP-2 on gastric emptying in humans have yielded inconsistent results, with some studies showing no effect and others documenting a GLP-2–dependent delay in gastric emptying1

  • human studyIn patients with short bowel syndrome, teduglutide proved effective in reducing the need for parenteral nutrition, thus improving the quality of life of these patients.15

  • human studyTeduglutide is effective after the period of intestinal adaptation after surgery, reducing the need for HPN and in some cases even allowing it to be suspended16

  • human studyThe response is heterogeneous, increasing progressively up to 2 years after the start of treatment and reaching 82% in some series16

  • human studyThe presence of colon in continuity is a negative predictor of early response, but a positive predictive factor for the withdrawal of HPN16

  • human studyTeduglutide is effective and safe and data from pivotal trials for the treatment of patients with SBS are confirmed in real life16

  • human studyTeduglutide has shown encouraging results in the management of short bowel syndrome18

  • human studyPilot studies suggest that GLP-1 may be less potent than teduglutide21

  • human studyIn patients with short bowel syndrome, teduglutide proved effective in reducing the need for parenteral nutrition, thus improving the quality of life of these patients.26

  • human studyA pilot phase II trial for ALX-0600 began during the third quarter of 1999 for short bowel syndrome27

  • human studyThe pilot phase II trial was designed to measure safety, tolerability, and drug-related improvements in nutrient absorption and physical changes in the gut27

  • human studyALX-0600 began pivotal phase II trials in 2000 following completion of the pilot trial27

  • expert opinionAGA clinical practice update recommends teduglutide administration only in carefully selected patients after optimization of diet and conventional treatments due to its significant adverse effects and costs10

  • expert opinionTeduglutide is designated an orphan drug by FDA for use in short bowel syndrome10

  • expert opinionTeduglutide is the preferred agent for PN/IV volume reduction or successful weaning in short bowel syndrome/intestinal failure patients19

  • expert opinionTeduglutide was approved by the US Food and Drug Administration (Gattex) and the European Medicines Agency (Revestive)21

How it works

Based on 3 human trial findings, 1 human study finding, 28 expert opinion findings and 2 theoretical findings.

  • human trialTeduglutide is a glucagon-like peptide-2 analogue that increases intestinal absorption20

  • human trialTeduglutide is a recombinant analogue of human glucagon-like peptide-2 (GLP-2)23

  • human trialGLP-2 is a naturally occurring hormone that regulates the growth, proliferation and maintenance of cells lining the gastrointestinal tract23

  • human studyTeduglutide is a recombinant analog of human glucagon-like peptide-2 that regulates the functional and structural integrity of the cells lining the gastrointestinal tract5

  • expert opinionTeduglutide is a recombinant analog of human glucagon-like peptide (GLP)-21

  • expert opinionThe primary effects of GLP-1 are to increase postprandial insulin levels, inhibit glucagon secretion, and slow gastric emptying1

  • expert opinionThe primary effects of GLP-2 are to increase growth of intestinal epithelium, maintain intestinal mucosal morphology and function, and regulate energy intake1

  • expert opinionUnlike GLP-1, GLP-2 has limited effect on insulin secretion or glucose homeostasis1

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  • expert opinionIn contrast to GLP-1, GLP-2 does not decrease pancreatic glucagon secretion1

  • expert opinionHuman GLP-2 (hGLP-2) is a systemic nutrient peptide hormone derived from proglucagon containing 33 amino acids2

  • expert opinionGLP-2 is expressed, transcribed, and translated from the glucagon motif and is secreted by L-type endocrine cells in the distal small intestine and colon2

  • expert opinionGLP-2 can induce the proliferation of intestinal crypt cells, inhibit the apoptosis of intestinal epithelial cells and gastric acid secretion, promote the repair of damaged intestinal mucosa and absorption of intestinal nutrients, enhance the intestinal blood supply, delay gastric wall peristalsis, and regulate intestinal mucosal barrier function2

  • expert opinionGLP-2 analogs contain one or more substitutes for specific components of natural peptides compared with human GLP-22

  • expert opinionTeduglutide is the first glucagon-like peptide 2 analogue4

  • expert opinionTeduglutide was developed to have a longer half-life than native GLP-28

  • expert opinionTeduglutide is a biosynthetic (recombinant DNA origin) analog of human glucagon-like peptide-2 (GLP-2)10

  • expert opinionTeduglutide is a GLP-2 (Glucagon like peptide-2) related compound12

  • expert opinionTeduglutide is a glucagon-like peptide 2 analog14

  • expert opinionTeduglutide improves intestinal rehabilitation by promoting mucosal growth14

  • expert opinionTeduglutide may restore gastric emptying and secretion14

  • expert opinionThe fluid composite effect reflects the increase in intestinal fluid absorption and reduction in diarrhea14

  • expert opinionTeduglutide is a recombinant analog of human glucagon-like peptide (GLP) 221

  • expert opinionGut hormones may improve structural and functional intestinal adaptation following intestinal resection by decreasing rapid gastric emptying and hypersecretion, increasing intestinal blood flow, and promoting intestinal growth21

  • expert opinionSynergistic effects may be seen by co-treatment with GLP-221

  • expert opinionTeduglutide is a recombinant analog of human glucagon-like peptide 222

  • expert opinionGlucagon-like peptide 2 improves structural and functional intestinal adaptation following intestinal resection by decelerating rapid gastric emptying22

  • expert opinionGlucagon-like peptide 2 decreases gastric hypersecretion22

  • expert opinionGlucagon-like peptide 2 increases intestinal blood flow22

  • expert opinionGlucagon-like peptide 2 promotes intestinal growth22

  • expert opinionTeduglutide is a 33–amino acid recombinant analog of the human glucagon-like peptide-2 (GLP-2)25

  • expert opinionGLP-2 is a peptide that is secreted primarily from the lower gastrointestinal tract25

  • expert opinionGLP-2 agonists (e.g., teduglutide) promote mucosal growth28

  • theoreticalTeduglutide is a glucagon-like peptide-2 (GLP-2) analogue produced in Escherichia coli cells by recombinant DNA technology6

  • theoreticalGLP-2 stimulates the growth of the lining of the small intestine, thus increasing the absorptive area of the intestine27

Dosing

Based on 13 human trial findings and 5 expert opinion findings.

  • human trialThe recommended dose of Revestive in adults is 0.05 mg/kg body weight once daily6

  • human trialThe recommended dose of Revestive in children and adolescents (aged 1 to 17 years) is 0.05 mg/kg body weight once daily6

  • human trialIn patients with moderate and severe renal impairment (creatinine clearance less than 50 ml/min), and end-stage renal disease, the daily dose should be reduced by 50%6

  • human trialNo dose adjustment is necessary in patients above the age of 65 years6

  • human trialNo dose adjustment is necessary for patients with mild and moderate hepatic impairment based on a study conducted in Child-Pugh grade B subjects6

  • human trialThe reconstituted solution should be administered by subcutaneous injection once daily, alternating sites between 1 of the 4 quadrants of the abdomen6

  • human trialRevestive should not be administered intravenously or intramuscularly6

  • human trialThe recommended dose of Teduglutide Viatris is 0.05 mg/kg body weight once daily11

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  • human trialIn children below the age of two years, treatment should be evaluated after 12 weeks11

  • human trialNo dose adjustment is necessary in patients above the age of 65 years11

  • human trialNo dose adjustment is necessary for adult or paediatric patients with mild renal impairment11

  • human trialIn adult or paediatric patients with moderate and severe renal impairment (creatinine clearance less than 50 ml/min), and end-stage renal disease, the daily dose should be reduced by 50%11

  • human trialProposed dosage of teduglutide is 0.05 mg/kg subcutaneous injection once daily, altering sites between 1 of the 4 quadrants of the abdomen, or into alternating thighs or alternating arms25

  • expert opinionTeduglutide can be dosed subcutaneously daily8

  • expert opinionTeduglutide should be administered by sub-Q injection only; do not administer IV or IM10

  • expert opinionTeduglutide is administered once daily10

  • expert opinionDosage for pediatric patients ≥1 year of age and adults is 0.05 mg/kg once daily10

  • expert opinionIn patients with Clcr <60 mL/minute, dosage should be reduced by 50% (i.e., to 0.025 mg/kg once daily)10

How the body handles it

Based on 1 human trial finding, 9 human study findings, 1 in vitro finding and 1 expert opinion finding.

  • human trialteduglutide has a longer half life than native GLP-213

  • human studyA one-compartment model with first-order absorption and linear elimination adequately characterized the PKs of teduglutide5

  • human studyIn patients with SBS, the apparent clearance (CL/F) of teduglutide was 16.0 L/h5

  • human studyIn patients with SBS, the volume of distribution (V/F) of teduglutide was 33.9 L5

  • human studyIn patients with SBS, the elimination half-life of teduglutide was 1.47 h5

  • human studyCL/F depended on body weight and renal function5

  • human studyV/F depended on body weight and age5

  • human studySix single-dose pharmacokinetic (PK) studies were conducted25

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  • human studyThree multiple-dose pharmacokinetic/pharmacodynamic (PK/PD) studies were conducted25

  • human studyTeduglutide formulation strength and SC injection volume appear to have an impact on teduglutide PK upon SC administration25

  • in vitroFour in vitro drug-drug interaction studies were conducted25

  • expert opinionREVESTIVE (teduglutide) has an extended half-life7

Safety and side effects

Based on 14 human trial findings, 8 human study findings, 1 animal finding and 5 expert opinion findings.

  • human trialNo serious adverse events, deaths, or discontinuations due to an adverse event were reported during the study1

  • human trialSafety and efficacy in pediatric patients have not been established9

  • human trialIn studies of up to 24 weeks' duration, teduglutide appears to be safe and well tolerated13

  • human trialIn studies of up to 24 weeks' duration, teduglutide appears to be safe and well tolerated14

  • human trialOnly one serious adverse event (abdominal pain) was considered related to teduglutide17

  • human trialAdverse events observed were in line with known impacts of short bowel syndrome with intestinal failure and adverse reactions to teduglutide17

  • human trialTeduglutide was well tolerated in infants and children with short bowel syndrome with intestinal failure17

  • human trialAdverse events were mostly of mild to moderate severity and generally consistent with the underlying condition or known mechanism of the drug (e.g. central line-related issues, gastrointestinal events)20

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  • human trialAdverse events from teduglutide were mainly of gastrointestinal origin and consistent with the known mechanism of action21

  • human trialTeduglutide had an acceptable tolerability profile with adverse events generally of gastrointestinal origin22

  • human trialSubcutaneous teduglutide had an acceptable tolerability profile23

  • human trialThe most frequently reported adverse events were of gastrointestinal origin, consistent with the underlying disease condition and the known mechanism of action of teduglutide23

  • human trialAn extension study (CL0600-005) studied the long term safety of 0.05 mg/kg/day and 0.10 mg/kg/day daily doses of teduglutide25

  • human trialAnti-drug antibodies (ADA) were assessed in Phase 3 studies with SBS subjects25

  • human studyTeduglutide-associated adverse events occurred in 27 System Organ Classes (SOC)4

  • human studyWeight decreased was a teduglutide-associated adverse event4

  • human studyVascular device infection was a teduglutide-associated adverse event4

  • human studyDehydration was a teduglutide-associated adverse event4

  • human studyNephrolithiasis was a previously unreported adverse event associated with teduglutide4

  • human studyRenal and urinary disorders emerged as a new adverse event signal for teduglutide4

  • human studyThe most common side effects are gastrointestinal in the early stages of treatment16

  • human studyThere are late complications related to the stoma or the occurrence of colon polyps, although the frequency of the latter is very low16

  • animalTeduglutide has the potential to cause hyperplastic changes, including neoplasia, because of its mechanism of action and tumor findings in animal carcinogenicity studies10

  • expert opinionREVESTIVE is contraindicated in patients with active gastrointestinal (GI) malignancy9

  • expert opinionREVESTIVE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation9

  • expert opinionPretreatment colonoscopy and upper GI endoscopy with removal of polyps within 6 months prior to initiation of therapy is required in adults10

  • expert opinionFollow-up colonoscopy and upper GI endoscopy at the end of 1 year of therapy and at least every 5 years thereafter is required in adults10

  • expert opinionOptimal patient selection and long-term safety of teduglutide need further evaluation19

What people use it for

Based on 10 human trial findings, 2 human study findings, 13 expert opinion findings and 3 theoretical findings.

  • human trialTwo phase III studies evaluated teduglutide with an extension period in adult Japanese patients with short bowel syndrome and intestinal failure3

  • human trialTeduglutide (Revestive) is indicated for the treatment of patients aged 1 year and above with Short Bowel Syndrome6

  • human trialTreatment effect should be evaluated after 6 months in adults6

  • human trialA treatment period of 12 weeks is recommended in paediatric patients after which treatment effect should be evaluated6

  • human trialREVESTIVE (teduglutide for injection) is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support9

  • human trialTeduglutide is indicated for treatment of short bowel syndrome in adults and pediatric patients ≥1 year of age who are dependent on parenteral support10

  • human trialTeduglutide Viatris is indicated for the treatment of patients 4 months corrected gestational age and above with Short Bowel Syndrome (SBS)11

  • human trialContinued treatment is recommended for patients who have weaned off parenteral nutrition11

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  • human trialTeduglutide is approved in the EU for the treatment of short bowel syndrome (SBS) in patients aged ≥1 year who are stable following a period of postsurgical intestinal adaptation20

  • human trialSubcutaneous teduglutide is the first long-term medical therapy approved for the treatment of adult patients with SBS who are dependent on parenteral support23

  • human studyTeduglutide is approved for the treatment of patients with short bowel syndrome (SBS) who are dependent on parenteral support (PS)5

  • human studyTeduglutide is an agonist of glucagon-related peptide (aGLP2) effective as a treatment for patients with short bowel syndrome (SBS)16

  • expert opinionTeduglutide is a novel therapy recently approved for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support1

  • expert opinionShort bowel syndrome (SBS) is a clinical condition characterized by a failure to achieve optimal intestinal adaptation, which is necessary to maintain oral/enteral autonomy2

  • expert opinionShort bowel syndrome (SBS) is a rare and potentially life-threatening malabsorptive condition caused by a significant loss of functional bowel mass or physical bowel mass secondary to extensive intestinal resection2

  • expert opinionSBS is the most common cause of chronic intestinal failure, accounting for approximately 75% of cases of chronic intestinal failure in adults and 50% such events in children2

  • expert opinionTeduglutide is a glucagon-like peptide-2 analog used in intestinal rehabilitation for patients with short bowel syndrome2

  • expert opinionTreatment should be initiated under the supervision of a medical professional with experience in the treatment of SBS9

  • expert opinionTreatment should not be initiated until the patient is stable following a period of intestinal adaptation9

  • expert opinionTeduglutide Viatris is a generic medicinal product approved through the centralised procedure as a generic of a centrally authorised product12

  • expert opinionShort bowel syndrome results from surgical resection, congenital defect or disease-associated loss of absorption14

  • expert opinionTeduglutide represents a new drug treatment strategy available for short bowel syndrome management18

  • expert opinionFollowing PN/IV elimination with teduglutide, patients need long-term monitoring for nutritional deficiencies19

  • expert opinionTeduglutide has been approved in the US and Europe for short bowel syndrome-associated intestinal failure22

  • expert opinionTeduglutide is part of medical management for intestinal failure involving GLP-2 agonists28

  • theoreticalALX-0600 (a GLP-2 analog) has potential for treatment of short bowel syndrome27

  • theoreticalALX-0600 has potential for mucositis associated with cancer chemotherapy27

  • theoreticalALX-0600 has potential for inflammatory bowel disease27

Points of contention

Where the evidence is unsettled, thin, or says less than the popular claim — worth knowing before you draw conclusions.

Contested

Renal dose-reduction thresholds differ between EU and US sources.

EMA sources state the 50% dose reduction applies to creatinine clearance <50 mL/min (moderate/severe renal impairment and ESRD), while the drugs.com monograph states the 50% reduction applies at Clcr <60 mL/minute (to 0.025 mg/kg once daily).

Contested

Approved minimum age varies across labels.

The Shire/Revestive US-style datasheet (Teduglutide for injection) states safety and efficacy in pediatric patients have not been established and it is for adults, while EU labels indicate use from age 1 year (Revestive, teduglutide) and drugs.com from ≥1 year (Teduglutide Monograph for Professionals - Drugs.com); the Teduglutide Viatris EU label extends the indication to patients 4 months corrected gestational age and above (Teduglutide Viatris, INN-teduglutide).

Limited evidence

Pediatric/infant efficacy data come from very small samples.

The pediatric RCT (Efficacy and Safety of Teduglutide in Infants and Children With Short Bowel Syndrome Dependent on Parenteral Support.) response rates are based on small numbers (e.g., 4/7 infants, 4/6 children), and Teduglutide Viatris, INN-teduglutide notes there are no data available in pediatric patients after 6 months, limiting long-term pediatric conclusions.

Limited evidence

Long-term safety and cancer/hyperplasia risk not fully characterized.

Neoplasia potential is based on mechanism and animal carcinogenicity studies (Teduglutide Monograph for Professionals - Drugs.com); FAERS analysis flagged new signals like nephrolithiasis and renal/urinary disorders (Frontiers | The real-world analysis of adverse events with teduglutide: a pharmacovigilance study based on the FAERS database); and reviews note optimal patient selection and long-term safety need further evaluation (Weaning from Parenteral Nutrition.).

Contested

Effect of GLP-2/teduglutide on gastric emptying is inconsistent across studies.

A randomized, double-blind, placebo-controlled, multiple-dose, parallel-group clinical trial to assess the effects of teduglutide on gastric emptying of liquids in healthy subjects | BMC Gastroenterology | Springer Nature Link reports teduglutide 4 mg/day for 10 days did not affect gastric emptying in healthy subjects and notes prior human GLP-2 studies yielded inconsistent results (some no effect, some delay), whereas several reviews describe teduglutide as decelerating rapid gastric emptying as part of its therapeutic mechanism (Teduglutide, a novel glucagon-like peptide 2 analog, in the treatment of patients with short bowel syndrome, New approaches to the treatments of short bowel syndrome-associated intestinal failure.).

Using it with other compounds

Check a stack
  • KPVComplementary

    No documented conflict

    Both target the gut lining but by entirely different routes: KPV calms mucosal inflammation (NF-κB suppression, reduced colitis severity in animal models), while teduglutide is a GLP-2 agonist that stimulates intestinal epithelial growth and repair. Pairing an inflammation-dampener with a growth/repair signal is a logically complementary approach to restoring a damaged gut barrier, though this combination is only anecdotally supported.

    Tier 4Theoretical — not established

    What the research doesn't fully establish

    Both peptides' mechanisms clearly establish the shared dimension of gut_barrier_integrity through distinct pathways: KPV suppresses mucosal inflammation (NF-κB inhibition, reduced colitis severity, mucosal barrier repair in animal models) while teduglutide promotes epithelial growth, proliferation, and mucosal repair via GLP-2 receptor signaling. The proposed relationship as 'complementary' is justified—they address barrier integrity through mechanistically different routes (inflammation resolution vs. tissue growth/repair), which logically complement each other. The explanation accurately reflects both mechanisms' documented effects on the gut barrier, and the caveat about anecdotal support appropriately acknowledges the lack of direct clinical evidence for the combination.

    Shares gut barrier integrity

  • LL-37Complementary

    No documented conflict

    Both support repair of epithelial/mucosal surfaces by different means: teduglutide promotes intestinal epithelial proliferation, while LL-37 drives keratinocyte/epithelial migration, wound closure and antimicrobial defense at mucosal barriers. They can reinforce barrier healing from separate pathways, though LL-37 can be cytotoxic at higher concentrations, so this is more speculative.

    Tier 4Theoretical — not established

    What the research doesn't fully establish

    Both peptides' mechanisms clearly support tissue_repair through distinct but complementary pathways affecting epithelial/mucosal surfaces. Teduglutide explicitly promotes intestinal epithelial growth, proliferation, and mucosal repair via GLP-2 receptor signaling. LL-37 explicitly supports keratinocyte migration, wound healing, and angiogenesis via multiple pathways (FPR2, TLRs, EGFR transactivation, VEGF signaling). The proposed relationship correctly identifies that they work through different mechanisms (proliferation/growth vs. migration/wound closure/antimicrobial defense) on epithelial barriers. Both are tagged with tissue_repair. The caveat about LL-37's cytotoxicity at higher concentrations is appropriately noted in the explanation and does not contradict the complementary relationship at therapeutic concentrations. The mechanisms justify this as a supported complementary relationship.

    Shares tissue repair

  • PlecanatideStack with caution

    Worth caution

    Both act locally in the intestine but pull in opposite directions on fluid handling. Teduglutide (a GLP-2 agonist) is used to help a compromised gut absorb more fluid and nutrients, while plecanatide deliberately increases fluid secretion into the gut lumen to loosen stool. Combining them could work against each other — a secretagogue like plecanatide may aggravate fluid loss in someone whose treatment goal is to retain fluid — so they should not be casually stacked without medical oversight.

    Tier 4Theoretical — not established

    What the research doesn't fully establish

    The proposed relationship claims shared dimensions of 'gut_barrier_integrity' and 'mucosal_repair,' but the mechanism descriptions do not support these as shared dimensions. Plecanatide's mechanisms focus on cGMP signaling, CFTR-mediated chloride/bicarbonate secretion, and increased intestinal fluid secretion—with no mention of barrier integrity or mucosal repair. Teduglutide explicitly targets mucosal repair, epithelial growth, and barrier function (tagged with gut_barrier_integrity and mucosal_repair). The mechanisms describe fundamentally different pathways and effects. While the explanation correctly identifies opposing effects on fluid handling (a valid clinical concern), this opposition does not constitute a shared dimension of barrier integrity or mucosal repair. The caution relationship may be clinically reasonable, but it is not justified by the claimed shared dimensions in the mechanism material provided.

    Shares gut barrier integrity · mucosal repair

  • ElafinComplementary

    May be complementary

    Teduglutide drives intestinal epithelial growth and barrier repair through the GLP-2 receptor, while elafin protects that same mucosa by neutralizing destructive proteases and calming inflammation. Different mechanisms both supporting gut mucosal integrity and repair.

    Tier 3Largely anecdotal — commonly discussed

    What the research doesn't fully establish

    Both peptides' mechanisms clearly support mucosal_repair and tissue_repair functions through distinct but complementary pathways. Elafin inhibits neutrophil serine proteases (elastase, proteinase 3) and modulates NF-κB/inflammatory signaling to protect mucosal tissue from enzymatic destruction. Teduglutide activates GLP-2 receptor signaling to promote intestinal epithelial growth, proliferation, and barrier function. The mechanisms describe non-overlapping approaches to the same tissue outcome: one protective/anti-degradative, one growth/regenerative. Both are explicitly tagged with mucosal_repair and tissue_repair in their approved tags, and the explanation accurately reflects how their distinct molecular mechanisms would work synergistically on intestinal mucosa.

    Shares mucosal repair · tissue repair

Safety and side effects

Safety and tolerability

In studies of up to 24 weeks' duration, teduglutide appears safe and well tolerated with an acceptable tolerability profile. Adverse events were mainly gastrointestinal, consistent with the underlying condition and the known mechanism of action. In a healthy-subject gastric emptying study, no serious adverse events, deaths, or discontinuations due to adverse events were reported. In pediatric trials, teduglutide was well tolerated in infants and children with SBS-IF, with only one serious adverse event (abdominal pain) considered related to teduglutide. No clinically significant differences in safety and efficacy were observed between subjects younger and older than 65 years.

Neoplasia and hyperplasia risk

Because of its trophic (growth-promoting) mechanism, teduglutide has the potential to cause hyperplastic changes, including neoplasia, based on its mechanism of action and tumor findings in animal carcinogenicity studies. Accordingly:

  • Pretreatment colonoscopy and upper GI endoscopy with removal of polyps within 6 months prior to initiation is required in adults.
  • Follow-up colonoscopy/upper GI endoscopy at the end of year 1 and at least every 5 years thereafter.
  • Teduglutide (Revestive) is contraindicated in patients with active gastrointestinal malignancy and in those hypersensitive to the drug or any formulation ingredient.

Long-term safety and cancer/hyperplasia risk are not fully characterized.

Pharmacovigilance signals

An FAERS pharmacovigilance analysis (10,114 reports with teduglutide as primary suspect, Q1 2013–Q3 2023) found teduglutide-associated adverse events across 27 System Organ Classes, with a median time to occurrence of 393 days. Notable events included weight decreased (n=805), vascular device infection (n=683), dehydration (n=596), and nephrolithiasis (n=146). Renal/urinary disorders and nephrolithiasis emerged as new/previously unreported adverse event signals. In real-world observation, the most common side effects are gastrointestinal in the early stages of treatment, with late complications related to the stoma or occurrence of colon polyps (though colon polyp frequency is very low).

Immunogenicity and monitoring

Anti-drug antibodies (ADA) were assessed in phase 3 studies, and an extension study (CL0600-005) evaluated long-term safety of the 0.05 and 0.10 mg/kg/day doses. Following elimination of parenteral/IV support, patients need long-term monitoring for nutritional deficiencies.

Reconstitution and handling

Formulation and reconstitution

Teduglutide is supplied as 5 mg per vial, reconstituted with 0.5 mL sterile water to a 10 mg/mL concentration. A maximum of 0.38 mL (3.8 mg) is deliverable from the reconstituted vial. The 5 mg kit is not recommended for patients under 10 kg body weight.

Dosing

  • Recommended dose: 0.05 mg/kg body weight once daily by subcutaneous injection in adults and pediatric patients ≥1 year of age.
  • An alternative dose of 0.10 mg/kg/day was tested in clinical studies alongside the 0.05 mg/kg/day dose.

Administration

Teduglutide must be administered by subcutaneous injection only — it must not be given intravenously or intramuscularly. Injection sites should be rotated: among one of the four abdominal quadrants, alternating thighs, or alternating arms.

Dose adjustments

  • Renal impairment: In moderate and severe renal impairment (creatinine clearance <50 mL/min) and end-stage renal disease, the daily dose should be reduced by 50%. (Note: the drugs.com monograph instead states the 50% reduction — to 0.025 mg/kg once daily — applies at Clcr <60 mL/minute; EU/EMA sources use the <50 mL/min threshold.) No dose adjustment is necessary for mild renal impairment.
  • Age: No dose adjustment is necessary in patients over 65 years.
  • Hepatic impairment: No dose adjustment is necessary for mild and moderate hepatic impairment (based on a study in Child-Pugh grade B subjects).

Initiation and evaluation

Treatment should be initiated under supervision of a medical professional experienced in SBS treatment and not until the patient is stable following intestinal adaptation. Treatment effect should be evaluated after 6 months in adults; in pediatric patients (and children below 2 years) a 12-week treatment period is recommended before evaluating effect. Some patients may take longer to respond; if no overall improvement is achieved after 12 months, the need for continued treatment should be reconsidered. Continued treatment is recommended for patients who have weaned off parenteral nutrition.

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