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Apraglutide
Apraglutide is a Small molecule drug developed by VectivBio AG. It is currently in Phase 3 development. Also known as: TA799.
Apraglutide is a glucagon-like peptide 2 receptor agonist, classified as an agonist drug. It is being studied in clinical trials for various conditions, including Short Bowel Syndrome, GVHD, and lymphoma.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Apraglutide |
|---|---|
| Also known as | TA799 |
| Sponsor | VectivBio AG |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD) (PHASE2)
- A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function (PHASE1)
- Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome. (PHASE3)
- Metabolic Balance Study of Apraglutide in Patients With Short Bowel Syndrome, Intestinal Failure (SBS-IF) and Colon-in-Continuity (CIC) (PHASE2)
- Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF (PHASE3)
- Relative Bioavailability of a New Presentation of Apraglutide Versus the Reference Formulation (PHASE1)
- Study of Pharmacokinetics and Safety of Apraglutide in Participants With Normal and Impaired Kidney Function. (PHASE1)
- Evaluation of Apraglutide on Gastric Emptying (PHASE1)
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:
- Apraglutide CI brief — competitive landscape report
- Apraglutide updates RSS · CI watch RSS
- VectivBio AG portfolio CI
Frequently asked questions about Apraglutide
What is Apraglutide?
Who makes Apraglutide?
Is Apraglutide also known as anything else?
What development phase is Apraglutide in?
Related
- Manufacturer: VectivBio AG — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: TA799
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing