Bottom line
Apraglutide (FE 203799) is a next-generation GLP-2 receptor agonist engineered for once-weekly Administered into the tissue layer under the skin. 定義の出典: Neutral gloss; usage context: Routes, devices, and absorption primer · 用語集 dosing in short bowel syndrome with intestinal failure (SBS-IF). It was developed by VectivBio (Ferring subsidiary) and acquired by Ironwood Pharmaceuticals in June 2023 (transaction value ~$1.1 billion). It has orphan drug designations in the US and EU. Phase 3 (STARS-021; NCT05216822) and a long-term extension (STARS-EXT) are ongoing or recently completed. The once-weekly dosing interval is the longest among GLP-2 analogs under development. STARS-021 primary completion was estimated in late 2025.
Identity and composition
| Field | Verified information |
|---|---|
| Preferred name | Apraglutide |
| Key aliases | FE 203799, V-203799 |
| Molecular/sequence identity | GLP-2 analog; multiple amino acid substitutions for extended The time for the amount of a substance in the body to fall by half. 定義の出典: Neutral gloss; usage context: Routes, devices, and absorption primer · 用語集 and DPP-4 resistance |
| Modifications/form | Administered into the tissue layer under the skin. 定義の出典: Neutral gloss; usage context: Routes, devices, and absorption primer · 用語集 solution; acetate salt |
| Stable identifiers | UNII: 5QG42Q7Q4V; CAS: 1295353-98-8; DrugBank: DB16699. No unambiguous exact-name PubChem compound was selected in this review. |
| Identity caveats | Distinct from teduglutide and glepaglutide, with different amino-acid substitutions and How a substance is absorbed, distributed, metabolized, and eliminated by the body; atlas pages report pharmacokinetic data such as half-life, metabolism, and clearance. 定義の出典: Neutral gloss; usage context: Routes, devices, and absorption primer · 用語集. A prior draft associated CID 137320520 without adequate verification; it is intentionally not used here. |
Development and approval status
| Jurisdiction | Status and indication | Product/source | As of |
|---|---|---|---|
| US (FDA) | A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. 定義の出典: Scope and selection methodology · 用語集; orphan drug designation for SBS | VectivBio/Ironwood | 2026 |
| EU (EMA) | Investigational; orphan designation | VectivBio/Ironwood | 2026 |
| UK (MHRA) | No marketing authorization | — | 2026 |
- UNITED STATES
- US (FDA): Investigational; orphan drug designation for SBS
- EU/EEA
- EU (EMA): Investigational; orphan designation
- UNITED KINGDOM
- UK (MHRA): No marketing authorization
- OTHER DOCUMENTED
- No OTHER DOCUMENTED row is present in the source status table
Sport status: WADA: S0 — non-approved pharmacological substance. As an unapproved GLP-2 receptor agonist, apraglutide falls under WADA S0 (any pharmacological substance not addressed by other sections of the Prohibited List and not approved by any governmental regulatory authority for human therapeutic use).
Mechanism and pharmacology
GLP-2 receptor agonist. Promotes intestinal mucosal growth, enhances absorptive capacity of the remnant bowel in SBS, reduces gastric emptying and secretion. Extended The time for the amount of a substance in the body to fall by half. 定義の出典: Neutral gloss; usage context: Routes, devices, and absorption primer · 用語集 enables once-weekly dosing, the longest dosing interval among GLP-2 analogs under development for SBS-IF. The mechanism is presumed similar to teduglutide and glepaglutide but with structure-based optimizations for DPP-4 resistance and reduced clearance.
Evidence by claim
| Claim/indication | Stage | Grade | Best human evidence | Main result | Important limitations |
|---|---|---|---|---|---|
| SBS-IF (PS reduction) | Phase 3 [1][2] | C | Phase 2 (NCT03408132); Phase 3 STARS-021 (NCT05216822) | Phase 2 showed PS reduction in A study in which participants and investigators know what is administered. 定義の出典: Neutral gloss; usage context: Evidence grading methodology · 用語集 portion | Full phase 3 published results not yet available at time of verification |
| Intestinal microbiota modulation | Exploratory [1] | D | Microbiome substudy (PMID 41903849) | Early ecological changes in gut microbiota with apraglutide | Exploratory endpoint; clinical significance undetermined |
- AグレードA: 特定の表示使用に対して確立
- BグレードB: 中等度のヒトエビデンス
- CグレードC: 予備的ヒトエビデンス
- DグレードD: 前臨床のみ
- EグレードE: 逸話的/マーケティング主張
- XグレードX: エビデンスが主張と矛盾するか、支持しない
Text alternative for the claim-evidence diagram. Each grade is defined below:
- A — Established for a specific labeled use
- 0 claims
- B — Moderate human evidence
- 0 claims
- C — Preliminary human evidence
- 1 claim: SBS-IF (PS reduction)
- D — Preclinical only
- 1 claim: Intestinal microbiota modulation
- E — Anecdotal/marketing claim
- 0 claims
- X — Evidence contradicts or does not support the claim
- 0 claims
Key studies
| Study | Design/population | Exposure studied | Endpoints and result | Limitations |
|---|---|---|---|---|
| NCT03408132 (phase 2) | A study in which participants and investigators know what is administered. 定義の出典: Neutral gloss; usage context: Evidence grading methodology · 用語集, SBS-IF, dose-ranging [1] | Apraglutide Administered into the tissue layer under the skin. 定義の出典: Neutral gloss; usage context: Routes, devices, and absorption primer · 用語集 once weekly, doses 5–40 mg | PS volume reduction; safety and tolerability | Small sample; no An inactive comparator used in a controlled study. 定義の出典: Neutral gloss; usage context: Evidence grading methodology · 用語集 comparator in some portions |
| STARS-021 (NCT05216822) | Phase 3, A study in which participants are assigned to the study material or a comparator by chance. 定義の出典: Neutral gloss; usage context: Evidence grading methodology · 用語集, N=~120, SBS-IF [1] | Apraglutide SC once weekly vs placebo | PS volume reduction from baseline; enteral autonomy | Primary completion ~2025; full results pending |
| STARS-EXT | Open-label extension [1] | Continued apraglutide | Long-term safety and durability of response | Ongoing |
| Microbiome analysis (PMID 41903849) | Exploratory substudy of intestinal microbiota in SBS-IF [1] | Apraglutide SC once weekly | Early ecological changes observed in gut microbiota | Exploratory; clinical relevance for SBS outcomes not yet determined |
Dose and administration evidence
Approved labeled regimen
No established or recommended human dose.
Studied regimens (not recommendations)
Phase 2: single Administered into the tissue layer under the skin. 定義の出典: Neutral gloss; usage context: Routes, devices, and absorption primer · 用語集 doses up to 40 mg; multiple doses in range 5–40 mg SC once weekly
Phase 3 (STARS-021): weekly SC dose; exact dose arm not publicly confirmed in full
What is not established
No established or recommended human dose.
Safety
Established label risks
Not applicable (A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. 定義の出典: Scope and selection methodology · 用語集).
Human-study signals
GI adverse events: nausea, abdominal pain, diarrhoea
Injection site reactions
Stoma enlargement / stoma-related events
Unknowns and product-quality risks
Long-term safety and immunogenicity profile
Comparative efficacy vs teduglutide and glepaglutide
Research-grade material not equivalent to pharmaceutical product
Interactions and special populations
No established drug interactions
No data in special populations
No pregnancy/lactation data
No paediatric studies
Regulatory, compounding, and sport notes
The World Anti-Doping Agency; its Prohibited List classifies many peptides as prohibited substances in sport. 定義の出典: WADA and sport regulation brief · 用語集: WADA Prohibited List class S0 (non-approved substances): pharmacological substances not addressed elsewhere in the list and with no current approval by any governmental regulatory health authority for human therapeutic use. 定義の出典: WADA and sport regulation brief · 用語集 — non-approved pharmacological substance. As an unapproved GLP-2 receptor agonist, apraglutide falls under WADA S0 (any pharmacological substance not addressed by other sections of the Prohibited List and not approved by any governmental regulatory authority for human therapeutic use).
Not scheduled
Orphan drug designation in US and EU
Any marketed vial is unapproved A clinical-stage candidate with scientific or public relevance. Investigation is not approval, and a studied exposure is not a recommendation. 定義の出典: Scope and selection methodology · 用語集 material
Ironwood Pharmaceuticals acquired VectivBio in June 2023 for $1.1 billion, indicating significant investment in development
Evidence gaps
Phase 3 confirmatory data from STARS-021 awaited
No head-to-head comparison to teduglutide or glepaglutide
Long-term durability of intestinal adaptation and effect on enteral autonomy
Immunogenicity data limited to early-phase studies
Patient-reported outcome data not yet published
Search notes
Databases and registries: ClinicalTrials.gov, PubMed, Ironwood/VectivBio pipeline
Search terms: apraglutide, FE 203799, short bowel syndrome, GLP-2 analog
Last searched: 2026-08-06
Inclusion emphasis: Phase 2/3 trials, regulatory designations, company disclosures
Sources
ClinicalTrials.gov. Phase 2 Study of Apraglutide in SBS-IF. https://clinicaltrials.gov/study/NCT03408132
ClinicalTrials.gov. STARS-021 Phase 3 Study. https://clinicaltrials.gov/study/NCT05216822
ClinicalTrials.gov. STARS-EXT Extension Study. https://clinicaltrials.gov/study/NCT06222515
Ironwood Pharmaceuticals pipeline (apraglutide). https://www.ironwoodpharma.com/pipeline/
DrugBank DB16699. https://go.drugbank.com/drugs/DB16699
UNII 5QG42Q7Q4V. https://precision.fda.gov/uniisearch/srs/unii/5QG42Q7Q4V
Microbiome analysis in SBS with apraglutide (2025). Clin Nutr ESPEN. PMID 41903849. https://pubmed.ncbi.nlm.nih.gov/41903849/
Systemic pharmacokinetics of therapeutic peptides (apraglutide reviewed). Clin Pharmacokinet. 2025. PMID 41661442. https://pubmed.ncbi.nlm.nih.gov/41661442/
Ironwood Pharmaceuticals acquisition of VectivBio (June 2023). https://www.ironwoodpharma.com/pipeline/
