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Teduglutide (Gattex/Revestive)33 residuesHGDGSFSDEMNTILDNLAARDFINWLIQTKITDEach bubble = one amino acid. Size = residue mass. Color = chemical class.Also known as: Gattex, Revestive, ALX-0600
Sixty-three percent of patients cut their IV nutrition by at least a fifth in 24 weeks. Teduglutide (Gattex in the US, Revestive in Europe) is an FDA-approved GLP-2 receptor agonist that rebuilds the intestinal lining from the inside out, increasing villus height, crypt depth, and absorptive surface area in patients with short bowel syndrome. The important STEPS trial (n=83)[1] proved it works. The catch: list price runs $520,000 to $550,000 per year, mandatory colonoscopy surveillance comes with the prescription, and stopping the drug reverses the intestinal gains within weeks. SBS patients use it to reduce or eliminate dependence on parenteral nutrition.
Sixty-three percent response versus thirty percent on placebo. That single number from the STEPS pivotal trial (n=83)[1] carried teduglutide to FDA approval for short bowel syndrome with intestinal failure. Teduglutide (Gattex, Revestive; CAS 197922-42-2) is a 33-amino acid recombinant analog of glucagon-like peptide-2. A single substitution at position 2 (glycine to alanine) blocks dipeptidyl peptidase-IV cleavage; that one change extends the half-life from roughly 7 minutes to about 2 hours. Enough for once-daily subcutaneous dosing. The drug triggers intestinal mucosal growth by activating GLP-2 receptors on subepithelial myofibroblasts and enteric neurons. Villus height increases. Crypt depth increases. Absorptive surface area expands. The practical result: patients absorb more fluid and nutrients from the gut, so they can reduce or stop parenteral nutrition. Long-term data backs this up. STEPS-2 [2] and STEPS-3 [3] confirmed sustained parenteral support reductions over 30 months of continuous treatment. In pediatric patients aged 1 year and older, Wales and colleagues (n=85)[4] reported an 82.1% response rate at 96 weeks. Both adults and children receive the same weight-based dose: 0.05 mg/kg/day. The limitations are real. The pivotal trial enrolled only 83 patients. Cost runs $520,000 to $550,000 per year at list price. Colonoscopy surveillance is mandatory. And intestinal adaptation reverses within weeks of stopping, which means therapy is indefinite for most patients.
Native GLP-2 lasts about 7 minutes in circulation before dipeptidyl peptidase-IV chews it apart. Teduglutide swaps glycine for alanine at position 2, and that single amino acid change blocks the enzyme's cleavage site. Half-life jumps to approximately 2 hours. Once injected subcutaneously (bioavailability around 88%, per Marier et al.)[5], teduglutide binds GLP-2 receptors on intestinal subepithelial myofibroblasts and enteric neurons. Receptor activation kicks off a trophic cascade: crypt cell proliferation accelerates, villus height and crypt depth increase, and new nutrient transporters appear on the mucosal surface. Mesenteric blood flow rises through nitric oxide-dependent vasodilation. Epithelial tight junctions tighten, improving barrier function. Teduglutide also slows gastric emptying and dials down gastric acid secretion. Both effects give the shortened bowel more time to absorb what passes through it. The net result is measurable. Plasma citrulline levels (a biomarker for enterocyte mass) start climbing within the first few weeks. By week 24 in the STEPS trial, 63% of patients on 0.05 mg/kg/day achieved at least a 20% reduction in weekly parenteral support volume. Peak plasma concentration hits between 3 and 5 hours post-injection, and the drug clears with a terminal half-life of roughly 2 hours (shorter in SBS patients, around 1.3 hours, likely due to altered distribution).
FDA-approved GLP-2 receptor agonist for SBS-associated intestinal failure with strong pivotal RCT evidence. STEPS trial (n=83): 63% achieved ≥20% reduction in weekly parenteral support volume at 24 weeks vs. 30% placebo (p=0.002). Long-term STEPS-2/3 data confirm sustained efficacy at 30+ months. Pediatric Wales et al. 2024 (n=85): 82.1% response rate at week 96 in children ≥1 year.
Jeppesen et al., Gut 2012 (PMID 21317170): STEPS pivotal RCT (n=83); 63% vs. 30% placebo response at 24 weeks (p=0.002)
Small pivotal trial (n=83 STEPS); rare disease limits head-to-head RCT data; colonoscopy surveillance burden; prohibitive cost ($520K–$550K/year) limits real-world access; no data on off-label use; regression of intestinal adaptation upon discontinuation requires indefinite therapy
Highly positive among the small SBS patient community. Life-changing reduction or elimination of TPN dependence is the dominant reported outcome. Main barriers are cost/insurance access and colonoscopy requirement, not tolerability. No off-label or performance community use documented.
SBS patients using teduglutide are the clinical trial population: there is no off-label community. Scientific evidence and patient community both report strong efficacy with TPN reduction as the primary outcome. Community concerns (cost, colonoscopy burden, abdominal side effects) are consistent with the clinical safety and access literature. No dose discrepancy exists: patients follow the FDA-approved 0.05 mg/kg/day weight-based dose.
| Level | Dose / Injection | Frequency |
|---|---|---|
| Beginner | 2,500mcg | Daily |
| Moderate | 3,500mcg | Daily |
| Aggressive | 5mg | Daily |
Teduglutide is supplied as a 5 mg lyophilized vial in 30-vial kits through GATTEX REMS-certified specialty pharmacies. Reconstitute with the 0.5 mL sterile water for injection included in the kit. Do not use bacteriostatic water. Gently roll the vial; do not shake. Let it sit 30 seconds before drawing. That gives you a 10 mg/mL concentration. For a 70 kg patient at the standard 0.05 mg/kg/day dose, you need 3,500 mcg (3.5 mg), which is 0.35 mL or 35 units on a 100-unit insulin syringe. A 50 kg patient draws 25 units (2,500 mcg). A 100 kg patient uses the full vial at 50 units (5,000 mcg). The non-obvious thing beginners miss: you must use each reconstituted vial within 3 hours. There are no preservatives. Don't prepare vials ahead of time. Bedtime dosing is the community favorite because it helps you sleep through the early abdominal bloating instead of sitting with it all day. Rotate injection sites across four abdominal quadrants; mark the quadrant on the vial if it helps you track rotation.
Teduglutide is used continuously as a chronic therapy. There is no cycling protocol: the drug is administered daily without breaks. Discontinuation leads to regression of intestinal adaptation within weeks. Regular colonoscopy surveillance and lipase/amylase monitoring every 6 months are required during ongoing therapy. Clinical reassessment of parenteral support needs should occur at least every 6 months.
Teduglutide is a chronic disease therapy, not a performance peptide. There is no receptor desensitization, hormonal axis suppression, or antibody formation rationale for cycling breaks at clinical doses. Intestinal mucosal adaptation is progressive and reverses within weeks of discontinuation: indefinite continuous therapy is required for maintained benefit.
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Expected: 63% response rate (≥20% PS reduction) at 24 weeks; continued improvement at 12+ months; some patients achieve complete TPN independence
Monitor: Colonoscopy: pre-treatment + 1 year post-initiation + every 5 years thereafter. Lipase/amylase + bilirubin every 6 months. Urine output daily (guides PS reduction timing). Monitor oral narrow-therapeutic-index drug levels (warfarin INR, cyclosporine, tacrolimus, levothyroxine TSH). Assess for fluid overload as PS volumes are weaned.
Pull one 5 mg teduglutide vial and the supplied 0.5 mL sterile water for injection from the refrigerator. Let both reach room temperature (about 15 minutes, or briefly hold the vial in your palm).
Gently roll between your palms for about 15 seconds. Do not shake. Let the vial stand for 30 seconds to allow complete dissolution.
The reconstituted concentration is 10 mg/mL. A 50 kg patient needs 0.25 mL (25 units on a 100-unit insulin syringe). A 70 kg patient needs 0.35 mL (35 units). A 100 kg patient uses the entire 0.5 mL vial (50 units). For renal impairment (eGFR under 60), cut the dose in half: 0.025 mg/kg/day.
Draw the calculated volume into a 29 or 30 gauge insulin syringe. Tap out air bubbles and push to the correct mark.
Inject subcutaneously into the abdomen, rotating across four quadrants daily. Thigh and upper arm are alternatives. Optional: ice the site for 30 to 60 seconds before injection to reduce sting.
Bedtime is commonly preferred.
There are no preservatives, and the solution is not stable beyond 3 hours.
Zorbtive (somatropin for injection) is FDA-approved for SBS. Historical triple approach pre-teduglutide: GH + glutamine + optimized diet. Teduglutide largely supplanted GH/glutamine due to superior durability. Some clinicians use both targeting complementary mechanisms (systemic anabolic vs. direct intestinal mucosal trophic). No dedicated RCT for the teduglutide + Zorbtive combination.
Zorbtive: 0.1 mg/kg/day SC (max 8 mg/day) for 4 weeks alongside optimized diet; teduglutide continued indefinitely. Historical use, not standard of care.
Historically part of the pre-teduglutide SBS triple approach (GH + glutamine + optimized diet). FDA-approved oral glutamine (Nutrestore, 30g/day) used as adjunct. Some clinicians continue alongside teduglutide for additional enterocyte support; no RCT data for the teduglutide + glutamine combination. Not standard of care.
Teduglutide increases intestinal absorption: enhanced warfarin absorption may significantly raise INR and bleeding risk. Monitor INR closely; dose adjustments likely needed.
Enhanced GI absorption may increase cyclosporine/tacrolimus levels and toxicity risk. Monitor drug levels closely when starting or adjusting teduglutide dose.
Pricing updated 2026-04-09
The FDA label carries a boxed-style warning about neoplastic growth acceleration. Teduglutide's trophic effects on intestinal mucosa could theoretically speed up growth of existing colorectal polyps or malignancies. That risk is why colonoscopy within 6 months before starting is mandatory, all polyps must be removed before the first injection, and surveillance colonoscopy is required at 1 year and every 5 years after. If malignancy is found at any point, the drug stops immediately. Abdominal pain is the most commonly reported adverse reaction, affecting more than 10% of patients. Nausea runs close behind at roughly 31% in long-term follow-up. Abdominal distension, vomiting, and injection site reactions (redness, swelling, nodules) round out the common side effect profile. Most of these are worst during the first 4 to 6 weeks as the intestinal mucosa undergoes its initial trophic response; they tend to stabilize after that window. Headache affects approximately 35% of patients in long-term use, making it the single most frequent complaint by raw percentage. Serious but less common risks include intestinal obstruction. The same mucosal growth that restores absorptive capacity can, in some cases, narrow an already compromised bowel lumen. Persistent severe abdominal pain warrants imaging for obstruction. Biliary and pancreatic disease is another concern; GLP-2 receptor activation has trophic effects on pancreatic tissue. The FDA label requires lipase, amylase, and bilirubin monitoring at baseline and every 6 months. Fluid overload catches patients and clinicians off guard more often than it should. As intestinal absorption improves, parenteral support volumes need to come down in parallel. Failing to reduce PS proactively causes fluid retention and, in patients with cardiac risk factors, can tip into congestive heart failure. Nephrolithiasis showed up as a post-marketing signal and warrants awareness, particularly in SBS patients who already have altered oxalate absorption. Upper respiratory tract infection and hypersensitivity reactions each appear in more than 10% of patients per the label. Injection site reactions respond to strict rotation across all four abdominal quadrants and brief icing before injection. Pregnancy is a consideration. Animal studies showed teratogenic effects. The label recommends use only if benefit clearly outweighs risk, and it should not be used during breastfeeding without careful evaluation. When to contact a prescriber: persistent severe abdominal pain (obstruction concern), rapid weight gain or edema (fluid overload), symptoms of pancreatitis, or any new rectal bleeding.
Verify Teduglutide (Gattex/Revestive) dosing and safety with a second opinion
FDA-approved product dispensed exclusively through GATTEX REMS-certified specialty pharmacies. Single-use lyophilized vials with no preservatives, supplied as 30-vial kits with sterile water for injection included. No compounded teduglutide market: cost and REMS barriers prevent gray-market or research-grade alternatives.
| Test | When | Target |
|---|---|---|
| Colonoscopy | Within 6 months before initiation (adult); at 1 year post-initiation; every 5 years thereafter. Pediatric: fecal occult blood pre-treatment; colonoscopy at 1 year. | No polyps (must be removed pre-treatment); no malignancy (mandatory discontinuation if detected) |
| Serum lipase and amylase (± bilirubin) | Baseline; every 6 months | Within normal limits; >3x ULN warrants therapy reassessment |
| Urine output | Daily during active PS weaning (weeks 5–24+) | ≥1 mL/kg/day increase above baseline → reduce PS by 10–20% |
| Renal function (eGFR / serum creatinine) | Baseline; every 6–12 months or with clinical changes | eGFR ≥60: standard dose. eGFR <60: reduce to 0.025 mg/kg/day |
| Oral narrow-therapeutic-index drug levels | At initiation and during significant PS weaning changes | Per individual drug therapeutic range |
| Fluid and electrolyte status | Ongoing during PS weaning; at each clinical assessment | No edema, normal electrolytes, stable cardiopulmonary status |
Intestinal trophic effects could theoretically accelerate neoplastic growth; surveillance is mandatory per FDA label
GLP-2 receptor activation has trophic effects on pancreatic and biliary tissue; biliary/pancreatic disease risk requires surveillance
Increase of ≥1 mL/kg/day above baseline is the clinical trigger for PS volume reduction; without monitoring, fluid overload risk
eGFR <60 mL/min/1.73m² requires 50% dose reduction to avoid 2.6x AUC accumulation
Improved intestinal absorption may increase serum levels of warfarin (INR), cyclosporine, tacrolimus, levothyroxine (TSH)
Failure to reduce PS as intestinal fluid absorption improves causes fluid overload and potential CHF exacerbation
Treatment initiation at 0.05 mg/kg/day. GI side effects (abdominal pain, nausea, distension) are most common early and typically mild-moderate. Parenteral support volumes are maintained while intestinal adaptation begins. Plasma citrulline levels may start rising, indicating enterocyte mass expansion.
Intestinal absorption capacity begins increasing measurably. First parenteral support volume reductions (10-20%) may be attempted based on urine output monitoring. Villus height and crypt depth begin increasing. GI side effects generally stabilize or improve.
Peak response period aligned with the STEPS trial endpoint. 63% of patients achieve ≥20% reduction in weekly parenteral support volume. Some patients may achieve complete days off parenteral nutrition. Lean body mass and nutritional markers improve. Continued monitoring for fluid balance is essential.
Sustained and often progressive reductions in parenteral support. STEPS-2 data show continued improvement beyond 24 weeks. Some patients achieve enteral autonomy (complete freedom from parenteral nutrition). Colonoscopy surveillance should be scheduled per protocol.
Long-term maintenance therapy with sustained benefits. STEPS-3 data confirm durability of response over 30+ months. Parenteral support reductions are maintained. Ongoing monitoring includes biannual lipase/amylase and periodic colonoscopy. Regression of adaptation occurs if therapy is discontinued.
Weeks 1 through 4: Treatment starts at 0.05 mg/kg/day. GI side effects are most common in this window, particularly abdominal pain, nausea (about 31% over the long term), and distension. Parenteral support volumes stay unchanged while the intestinal lining begins adapting internally. Plasma citrulline may start rising, which signals enterocyte mass is expanding. Bedtime dosing helps you sleep through the bloating. Weeks 5 through 12: Intestinal absorption capacity starts increasing measurably. If urine output has climbed at least 1 mL/kg/day above baseline, clinicians typically attempt the first parenteral support reductions of 10 to 20%. Villus height and crypt depth begin increasing histologically. GI side effects generally stabilize by week 6 to 8. Cautious optimism is the phrase that fits this window best. Weeks 13 through 24: This is the peak response window, matching the STEPS trial's primary endpoint. Sixty-three percent of teduglutide patients achieved at least a 20% reduction in weekly parenteral support volume (versus 30% on placebo). Some patients reach complete days off parenteral nutrition. Lean body mass and nutritional markers improve. Fluid management becomes the most active clinical issue, not side effects. Month 6 bloodwork (lipase and amylase) is due. Weeks 24 through 52: Benefits continue building. STEPS-2 data confirm continued parenteral support reduction beyond 24 weeks. Some patients achieve full enteral autonomy, which is the outcome community members describe as the most life-changing. The 1-year colonoscopy is due per protocol. Patients who responded keep improving; many don't plateau until 12 to 18 months. Year 2 and beyond: Long-term maintenance therapy with stable benefit. STEPS-3 [3] confirms durability at 30 months and beyond. Parenteral support reductions hold. Ongoing monitoring includes lipase and amylase every 6 months and colonoscopy at least every 5 years. The key long-term patient concern isn't side effects; it's insurance coverage continuity and annual prior authorization renewal. Stopping treatment causes intestinal adaptation to regress within weeks.
Intestinal mucosal adaptation begins; plasma citrulline levels start rising (early biomarker of enterocyte mass expansion). GI side effects most prevalent in this window. No PS reductions yet.
Abdominal pain, bloating, and nausea in first 2–4 weeks. No change in PS requirements: expected. Bedtime dosing reduces awareness of bloating.
Measurable increases in intestinal absorptive capacity. First PS volume reductions (10–20%) may be attempted if urine output increases ≥1 mL/kg/day above baseline. Villus height and crypt depth begin increasing histologically.
First signs of improvement. Some patients begin reducing PS days or volumes. GI side effects stabilize. Cautious optimism.
63% of teduglutide patients achieve ≥20% weekly PS volume reduction (vs. 30% placebo). Lean body mass and nutritional markers improve. Some patients achieve complete days off TPN.
Clear changes in PS volume and/or infusion days. Colon-in-continuity patients may approach TPN-free days. Month 6 biannual bloodwork (lipase/amylase).
STEPS-2 data: continued PS reduction beyond 24 weeks. Some patients achieve enteral autonomy. Annual colonoscopy due at 1 year post-initiation.
Patients who responded continue improving; plateau may not be reached until 12–18 months. Complete TPN independence is most life-changing reported outcome. Upcoming 1-year colonoscopy.
STEPS-3: durability confirmed at 30+ months. Adaptation regresses within weeks of discontinuation: indefinite therapy required.
Stable PS reduction on continuous therapy. Key long-term concern: insurance coverage continuity and annual authorization renewal.
Source: FDA Prescribing Information (Gattex), Section 12.3; Marier et al. J Clin Pharmacol 2010 PMID:19773525
Loading the interactive decay curve.
Teduglutide is FDA-approved (brand name Gattex in the US, Revestive in the EU) for adults and pediatric patients aged 1 year and older with short bowel syndrome associated with intestinal failure who require parenteral support. It carries full regulatory approval, not investigational or research-only status. Prescribing and dispensing are restricted under the GATTEX REMS (Risk Evaluation and Mitigation Strategy) program, also called the STEPS program. Both the prescriber and the dispensing specialty pharmacy must be enrolled. The drug is not available at retail pharmacies. There is no compounding pharmacy or grey-market version of teduglutide. The combination of REMS restrictions, prohibitive cost ($520,000 to $550,000/year at list price), and mandatory colonoscopy surveillance has prevented any research-chemical market from forming. WADA status is not relevant, as teduglutide has no performance-improving application. This content is for informational purposes only and does not constitute medical advice. Teduglutide should only be used under the supervision of a qualified healthcare provider experienced in managing short bowel syndrome.
Peptide Schedule Research TeamReviewed Apr 20267 Citations
