Drugs / Efimosfermin alfa
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07358546 | Mar 2026 → Oct 2027 expected | NAFLD1 | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1 | NCT07335198 | Mar → Aug 2026 overdue | NAFLD1 | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 1 | NCT03466203 | Feb 2018 → Nov 2019 | obesity disorder | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07704892 | Jul 2026 → Oct 2030 expected | metabolic dysfunction-associated steatohepatitis | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07701993 | Jul 2026 → Jul 2033 expected | metabolic dysfunction-associated steatohepatitis | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07221188 | Dec 2025 → Mar 2028 expected | NAFLD1 | GlaxoSmithKline | Recruiting | No outcome recorded |
| Phase 3 | NCT07221227 | Oct 2025 → Mar 2028 expected | NAFLD1 | GlaxoSmithKline | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-04-27 | GlaxoSmithKline | Regulatory GSK’s investigational liver therapy, efimosfermin, receives US FDA Breakthrough Therapy and EMA Priority Medicines (PRIME) designations for MASH gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that efimosfermin, a once-monthly investigational liver therapy, has been granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) and Priority Medicines (PRIME) Designation by the European Medicines Agency (EMA) for the treatment of MASH. |
| 2025-11-07 | GlaxoSmithKline | Results GSK presents data from its advancing liver pipeline at AASLD 2025 gsk.com ↗
Late breaking results for once-monthly efimosfermin in metabolic dysfunction-associated steatohepatitis (MASH), supporting the start of phase III clinical trials |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-04-27 | GlaxoSmithKline | GSK’s investigational liver therapy, efimosfermin, receives US FDA Breakthrough Therapy and EMA Priority Medicines (PRIME) designations for MASH gsk.com ↗ |
| 2025-11-07 | GlaxoSmithKline | GSK presents data from its advancing liver pipeline at AASLD 2025 gsk.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Efimosfermin alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07221227 ↗ |
| Known as | LLF580 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03466203 ↗ |
| Modality | Protein / enzyme biologic | “a genetically engineered variant of human fibroblast growth factor-21” PMID 34431493 ↗ Jan 2022 |
| Route | Subcutaneous | “LLF580 300 mg or placebo subcutaneously every 4 weeks for 3 doses” PMID 34431493 ↗ Jan 2022 |