Fianlimab
REGENERON PHARMACEUTICALS, INC. REGN · Melanoma; Advanced Non-Small Cell Lung Cancer; Non-small Cell Lung Cancer
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
5
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- REGENERON PHARMACEUTICALS, INC. REGN Source: Company record for REGENERON PHARMACEUTICALS, INC. (opens in a new tab)
- Indications
- Melanoma; Advanced Non-Small Cell Lung Cancer; Non-small Cell Lung Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 30 Jun 20232 linked trials
- Phase 3 Current stageFirst trial start 14 Jul 20225 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Fianlimab. Editors add each one with its source.
Filed application
No filed application is on record for Fianlimab. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Fianlimab.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06246916ClinicalTrials.gov record for NCT06246916 (opens in a new tab) | A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) | Phase 3 | Recruiting | 560 (estimated) | 22 Mar 2027 (estimated) | No |
| NCT05800015ClinicalTrials.gov record for NCT05800015 (opens in a new tab) | A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer | Phase 2/3 | Active, not recruiting | 160 (actual) | 16 Jan 2030 (estimated) | No |
| NCT05785767ClinicalTrials.gov record for NCT05785767 (opens in a new tab) | A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) | Phase 2/3 | Active, not recruiting | 149 (actual) | 28 Sep 2027 (estimated) | No |
| NCT05608291ClinicalTrials.gov record for NCT05608291 (opens in a new tab) | A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery | Phase 3 | Active, not recruiting | 1,564 (actual) | 27 Jul 2026 (estimated) | No |
| NCT05352672ClinicalTrials.gov record for NCT05352672 (opens in a new tab) | Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma | Phase 3 | Active, not recruiting | 1,546 (actual) | 12 Mar 2026 (actual) | No |
Publications listing NCT05352672 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Fianlimab.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT05800015 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05785767 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT06246916 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05608291 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05352672 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.