Drug

Gemcitabine

Regulatory activity · FDA

Actively researchedLate-stage developmentCooling momentum

Also known as 2',2'-Difluorodeoxycytidine, 2'-Deoxy-2',2'-difluorocytidine, Avgemsi, Difluorodeoxycytidine+9 more

2',2'-Difluorodeoxycytidine, 2'-Deoxy-2',2'-difluorocytidine, Avgemsi, Difluorodeoxycytidine, Gemzar, Infugem, Inlexzo, dFdC, dFdCyd, Gemcitabin, Gemcitabina, 4-amino-1-((2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)-tetrahydrofuran-2-yl)pyrimidin-2(1H)-one, Gemcitabinum.

RxNorm12574 ChEMBLCHEMBL888 ATCL01BC05UNIIB76N6SBZ8R

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003)

Clinical trial2026-07-24Results expected Q3 2027 · ClinicalTrials.gov

A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

Clinical trial2026-07-20Results expected Q2 2030 · ClinicalTrials.gov

A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitecan-hziy vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer

Clinical trial2026-07-20Results expected Q4 2028 · ClinicalTrials.gov

A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease

Clinical trial2026-07-17Results expected Q4 2029 · ClinicalTrials.gov

A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator's Choice of Adjuvant Chemotherapy in Participants With Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

Clinical trial2026-07-15Results expected Q1 2028 · ClinicalTrials.gov

A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Clinical trial2026-07-02Results expected Q1 2030 · ClinicalTrials.gov

An Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of the LM-302 Combination With Other Anti-tumor Treatment in Subjects With CLDN18.2-positive Advanced Gastro-Intestinal Cancer.

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

Recall (Class II): GEMCITABINE

Regulatory2026-06-10FDA

A randomized trial of pharmacological ascorbate, gemcitabine, and nab-paclitaxel for metastatic pancreatic cancer.

Research2024-10-02Redox biology

Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor-Positive Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: Primary Results From TROPION-Breast01.

Research2024-09-12Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Blockade of IL1β and PD1 with Combination Chemotherapy Reduces Systemic Myeloid Suppression in Metastatic Pancreatic Cancer with Heterogeneous Effects in the Tumor.

Research2024-09-01Cancer immunology research

Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer.

Research2024-03-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Gemcitabine

Aliases & brands

2',2'-Difluorodeoxycytidine2'-Deoxy-2',2'-difluorocytidineAvgemsiDifluorodeoxycytidineGemzarInfugemInlexzodFdCdFdCydGemcitabinGemcitabina4-amino-1-((2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)-tetrahydrofuran-2-yl)pyrimidin-2(1H)-oneGemcitabinum

RxNorm CUI

12574

ChEMBL ID

CHEMBL888

ATC codes

L01BC05

UNII

B76N6SBZ8R

Regulatory jurisdictions

fda

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities

FDA

Total events

fdaU.S. Food and Drug Administration· 1 event

2026-06-10RecallSafety

Recall (Class II): GEMCITABINE

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

199 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

199

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 199

Phase 136Phase 1 / 219Phase 291Phase 2 / 36Phase 342Phase 41Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Overall Survival and Disease Progression in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

TerminatedPH IVHoffmann-La Rochen=62009

A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)

Active, not recruitingPH IIIMerck Sharp & Dohme LLCn=5202031

Randomized Phase III Study of Second-Line Chemotherapy With or Without Panitumumab for KRAS Wild Type, Locally Advanced or Metastatic Pancreatic Adenocarcinoma

RecruitingPH IIISWOG Cancer Research Networkn=942030

RecruitingPH IIIBioNTech SEn=5582030

RecruitingPH IIIKey trialMerck Sharp & Dohme LLCn=1,0002030

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma

CompletedPH IIIKey trialMerck Sharp & Dohme LLCn=1,0692025

Phase II Study of Nab-Paclitaxel in Combination With Gemcitabine for Treatment of Recurrent/Refractory Sarcoma in Teenagers and Young Adults

CompletedPH IIH. Lee Moffitt Cancer Center and Research Instituten=592025

A Phase I/II Study Evaluating the Feasibility and Safety of Neoadjuvant Gemcitabine/Nab-paclitaxel (GA) and Concurrent Gemcitabine and Radiation Therapy Followed By Pancreatic Resection and Major Arterial Resection for Adenocarcinoma of the Pancreas (ARCAP) in Patients With Advanced Disease

CompletedPH I/IIUniversity Health Network, Toronton=112024

Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

CompletedPH IIIBristol-Myers Squibbn=5052024

A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months

CompletedPH IIIGrupo Español de Investigación en Cáncer de Ovarion=4172024

A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)

CompletedPH IIIG1 Therapeutics, Inc.n=1942024

Research activity

35 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20042025

Most influential

Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine.

The New England journal of medicine · 2013 · 4,886 cites

FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer.

The New England journal of medicine · 2018 · 2,091 cites

Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC.

The New England journal of medicine · 2020 · 1,238 cites

Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trial--INTACT 1.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2004 · 1,188 cites

Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma.

The New England journal of medicine · 2020 · 1,117 cites

Enfortumab Vedotin and Pembrolizumab in Untreated Advanced Urothelial Cancer.

The New England journal of medicine · 2024 · 719 cites

Related diseases

9 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Pancreatic Neoplasms12 Carcinoma, Pancreatic Ductal5 Adenocarcinoma2 Carcinoma, Non-Small-Cell Lung2 Lung Neoplasms2 Neoplasm Invasiveness2 Neoplasm Metastasis2 Urinary Bladder Neoplasms2 Urologic Neoplasms2

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Deoxycytidine

Studied across 16 of the same disease areas as Gemcitabine in the shared literature.

15 shared papers16 shared diseases

Paclitaxel

Studied across 15 of the same disease areas as Gemcitabine in the shared literature.

15 shared diseases6 shared papers

Cisplatin

Studied across 11 of the same disease areas as Gemcitabine in the shared literature.

11 shared diseases7 shared papers

Carboplatin

Studied across 9 of the same disease areas as Gemcitabine in the shared literature.

9 shared diseases3 shared papers

Fluorouracil

Studied across 9 of the same disease areas as Gemcitabine in the shared literature.

9 shared diseases3 shared papers

Irinotecan

Studied across 8 of the same disease areas as Gemcitabine in the shared literature.

8 shared diseases3 shared papers

Pembrolizumab

Studied across 11 of the same disease areas as Gemcitabine in the shared literature.

11 shared diseases1 shared paper

Leucovorin

Studied across 7 of the same disease areas as Gemcitabine in the shared literature.

7 shared diseases3 shared papers

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.