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Efimosfermin
Efimosfermin is a Small molecule drug developed by Boston Pharmaceuticals. It is currently in Phase 2 development. Also known as: BOS-580.
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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 | Efimosfermin |
|---|---|
| Also known as | BOS-580 |
| Sponsor | Boston Pharmaceuticals |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry (PHASE1)
- A Study of Efimosfermin Alfa in Adults With Hepatic Impairment (PHASE1)
- A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH (PHASE3)
- A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH (PHASE2)
- A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH (PHASE3)
- A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension (PHASE2)
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:
- Efimosfermin CI brief — competitive landscape report
- Efimosfermin updates RSS · CI watch RSS
- Boston Pharmaceuticals portfolio CI
Frequently asked questions about Efimosfermin
What is Efimosfermin?
Who makes Efimosfermin?
Is Efimosfermin also known as anything else?
What development phase is Efimosfermin in?
Related
- Manufacturer: Boston Pharmaceuticals — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: BOS-580
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing