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teduglutide 0.05
teduglutide 0.05 is a Small molecule drug developed by Shire. It is currently in Phase 2 development. Also known as: GATTEX.
Teduglutide 0.05 mg/kg/day is a glucagon-like peptide 2 receptor agonist used to treat Short Bowel Syndrome. It is administered subcutaneously as part of an open-label, Phase 3 study to evaluate its efficacy, safety, and pharmacokinetics.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | teduglutide 0.05 |
|---|---|
| Also known as | GATTEX |
| Sponsor | Shire |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients (PHASE4)
- A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome (PHASE3)
- A Study of Teduglutide in Japanese People With Short Bowel Syndrome
- Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS) (PHASE3)
- A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older (PHASE3)
- A Study of the Gut Barrier and Blood Vessel Inflammation in Individuals With and Without HIV (PHASE2)
- An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004 (PHASE3)
- Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- teduglutide 0.05 CI brief — competitive landscape report
- teduglutide 0.05 updates RSS · CI watch RSS
- Shire portfolio CI
Frequently asked questions about teduglutide 0.05
What is teduglutide 0.05?
Who makes teduglutide 0.05?
Is teduglutide 0.05 also known as anything else?
What development phase is teduglutide 0.05 in?
Related
- Manufacturer: Shire — full pipeline
- Also known as: GATTEX
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing