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STAR-0215
STAR-0215 is a Small molecule drug developed by Astria Therapeutics, Inc.. It is currently in Phase 2 development.
STAR-0215 is a small molecule being studied as a potential treatment for Hereditary Angioedema, administered via subcutaneous (SC) or intravenous (IV) injection. A Phase 1a clinical trial (NCT05477160) is assessing the safety, tolerability, and pharmacokinetics of STAR-0215 in healthy adult participants.
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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 | STAR-0215 |
|---|---|
| Sponsor | Astria Therapeutics, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of Navenibart in Participants With Hereditary Angioedema (PHASE3)
- A Long-Term Study of Navenibart in Participants With Hereditary Angioedema (PHASE3)
- A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema (PHASE2)
- A Study of STAR-0215 in Participants With Hereditary Angioedema (PHASE1, PHASE2)
- A Study of STAR-0215 in Healthy Adult Participants (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:
- STAR-0215 CI brief — competitive landscape report
- STAR-0215 updates RSS · CI watch RSS
- Astria Therapeutics, Inc. portfolio CI
Frequently asked questions about STAR-0215
What is STAR-0215?
Who makes STAR-0215?
What development phase is STAR-0215 in?
Related
- Manufacturer: Astria Therapeutics, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing