Lirafugratinib (Lyrfigtu)
Elevar Therapeutics
FDA approved, per FDA
No Phase 3 trial is registered. The FDA approval cites the Phase 1/2 REFOCUS trial (NCT04526106).
Since , the date of the source that reports this phase.
Summary
Lirafugratinib is a Lyrfigtu from Elevar Therapeutics. The source describes it as small molecule (FGFR2 inhibitor). It is being developed for previously treated unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement. The FDA approved it on Sep 23, 2026. Its trial records are NCT04526106, NCT07359820. The AI role named in the source is computational design. Registry records: NCT04526106, Phase 1/2, completed, updated Feb 27, 2026; NCT07359820, Phase 2, recruiting, updated Sep 3, 2026. FDA approval 2026-09-23. EMA review of the marketing authorisation application started 2026-10-01. The latest dated source is from Sep 23, 2026.
Built only from the sources listed on this page.
Facts
- Company
- Elevar Therapeutics (discovered by Relay Therapeutics)
- Indication
- Previously treated unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement
- Therapeutic area
- Oncology
- Modality
- Small molecule (FGFR2 inhibitor)
- AI role
- Computational design
- Phase in the source
- FDA approved, as of Sep 23, 2026
- Phase source
- Confirmed
- Board column
- Approved
Key readouts in the source
FDA approval 2026-09-23. EMA review of the marketing authorisation application started 2026-10-01.
AI evidence
AI source: Paper
Exception: this drug stays on the board although no source ties AI to it specifically. See the inclusion rule.
Discovered by Relay Therapeutics. Current developer: Elevar Therapeutics.
Discovered with Relay's Dynamo platform, using motion-based computational design (long-timescale molecular dynamics).
Trial records
- NCT04526106 on ClinicalTrials.gov (opens in new tab) Phase 1/2 Completed Updated
- NCT07359820 on ClinicalTrials.gov (opens in new tab) Phase 2 Recruiting Updated
Milestone timeline
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NCT04526106 record updated
Phase 1/2, Completed
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NCT07359820 record updated
Phase 2, Recruiting
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FDA page: FDA approved
FDA approval 2026-09-23. EMA review of the marketing authorisation application started 2026-10-01.
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FDA approval
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EMA review started
Marketing authorisation application EMEA/H/C/006899.
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Registry check
Registry shows Phase 1/2 completed and Phase 2 (sponsor Elevar).
NCT04526106 (opens in new tab)NCT07359820 (opens in new tab)
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