Pemigatinib
Also known as Pemazyre
INCYTE CORP INCY · Metastatic Cholangiocarcinoma; Unresectable Cholangiocarcinoma
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
NDA213736,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- INCYTE CORP INCY Source: Company record for INCYTE CORP (opens in a new tab)
- Indications
- Metastatic Cholangiocarcinoma; Unresectable Cholangiocarcinoma Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Application
- NDA 213736 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 213736 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 3 Jun 20191 linked trial
- Filed Completed
- Approved Current stageFirst approval 17 Apr 2020
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 Pemigatinib. Editors add each one with its source.
Filed application
No filed application is on record for Pemigatinib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Pemigatinib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT03656536ClinicalTrials.gov record for NCT03656536 (opens in a new tab)FIGHT-302 | A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma | Phase 3 | Terminated | 167 (actual) | 7 Jul 2025 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03656536 (opens in a new tab) |
Posted results on ClinicalTrials.gov for FIGHT-302
Serious adverse events (up to approximately 6 years): Randomized Period: Pemigatinib 13.5 mg QD 23 of 83; Randomized Period: Gemcitabine 1000 mg/m^2 Plus Cisplatin 25 mg/m^2 17 of 73; Transition Period: Pemigatinib 13.5 mg QD 9 of 42 Source: ClinicalTrials.gov results for NCT03656536 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing FIGHT-302 (2), 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
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA213736Action letter for NDA213736 (opens in a new tab) | Supplement 2 Efficacy | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA213736Action letter for NDA213736 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | priority | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
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)
AuthorisedOrphan medicineConditional
Pemazyre (EMEA/H/C/005266)
- Authorised
- Therapeutic area
- Cholangiocarcinoma
- Marketing authorisation holder
- Incyte Biosciences Distribution B.V.
- Active substance (INN)
- pemigatinib
- ATC code
- L01EN02
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name.
EMA page for Pemazyre (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 213736 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT03656536 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA213736 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.