Wednesday, July 8, 2026

Drug profile · INN

gemcitabine hydrochloride

gemcitabine hydrochloride (GEMCITABINE HYDROCHLORIDE) is a dna polymerase (alpha/delta/epsilon) inhibitor. Associated with Regeneron Ireland Designated Activity Company (DAC). Route of administration: injection. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 8
News articles 0
Drug details — gemcitabine hydrochloride
US status
approved
Class
Route
INJECTION
Patents
0
Programs
8
Data quality
0.89

Quick answer

gemcitabine hydrochloride (GEMCITABINE HYDROCHLORIDE) is a dna polymerase (alpha/delta/epsilon) inhibitor. Associated with Regeneron Ireland Designated Activity Company (DAC). Route of administration: injection. Current US regulatory status: approved.

Key facts

INN gemcitabine hydrochloride
Brand GEMCITABINE HYDROCHLORIDE
Mechanism DNA polymerase (alpha/delta/epsilon) inhibitor
Target DNA polymerase (alpha/delta/epsilon)
Route INJECTION
Formulation INJECTABLE

Mechanism of action

DNA polymerase (alpha/delta/epsilon) inhibitor

Primary target: DNA polymerase (alpha/delta/epsilon)

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. ALKS 4230-007 Phase 3 · Createrna Science and · Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Pr
  2. D9106C00001 Phase 3 · AstraZeneca · Patients with resectable Non-small Cell Lung Cancer (Stage I
  3. INCB123667-305 Phase 3 · Incyte · Ovarian cancer
  4. RMC-6236-302 Phase 3 · Revolution Medicines · Metastatic Pancreatic Ductal Adenocarcinoma
  5. ACR-368-201 Phase 2 · Acrivon Therapeutics · Endometrial cancer
  6. AT148009 Phase 2 · ALX ONCOLOGY HOLDINGS · Breast Cancer
  7. STRO-002-GM3 Phase 2 · SUTRO BIOPHARMA · Advanced Epithelial Ovarian Cancer (including Fallopian Tube
  8. SELECTIO-UC Approved · Telethon Foundation · metastatic or locally advanced urothelial cancer

Related & competitor drugs

  1. fludarabine phosphate DNA polymerase (alpha/delta/epsilon) inhibitor

Frequently asked questions

What is gemcitabine hydrochloride?

gemcitabine hydrochloride (GEMCITABINE HYDROCHLORIDE) is a dna polymerase (alpha/delta/epsilon) inhibitor. Associated with Regeneron Ireland Designated Activity Company (DAC). Route of administration: injection. Current US regulatory status: approved.

What is the brand name for gemcitabine hydrochloride?

GEMCITABINE HYDROCHLORIDE is a marketed brand name for gemcitabine hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of gemcitabine hydrochloride?

gemcitabine hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.