Last update 01 Aug 2025

Gemcitabine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Gemcitabine hydrochloride (JAN/USP), Gemcitabine Hydrochloride for jnjection, Gemcitabine Hydrochlride
+ [18]
Action
inhibitors
Mechanism
DNA inhibitors(DNA inhibitors), RNR inhibitors(Ribonucleotide reductase inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Breakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC9H12ClF2N3O4
InChIKeyOKKDEIYWILRZIA-OSZBKLCCSA-N
CAS Registry122111-03-9

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Bladder Cancer
Australia
02 Dec 2008
Locally Advanced Lung Non-Small Cell Carcinoma
Australia
02 Dec 2008
Locally Advanced Pancreatic Adenocarcinoma
Australia
02 Dec 2008
metastatic non-small cell lung cancer
Australia
02 Dec 2008
Pancreatic adenocarcinoma metastatic
Australia
02 Dec 2008
Recurrent ovarian cancer
Australia
02 Dec 2008
Transitional Cell Carcinoma
Japan
25 Nov 2008
Biliary Tract Neoplasms
Japan
31 Aug 2001
Lymphoma
Japan
31 Aug 2001
Ovarian Cancer
Japan
31 Aug 2001
Breast Cancer
United States
15 May 1996
Metastatic breast cancer
United States
15 May 1996
Non-Small Cell Lung Cancer
United States
15 May 1996
Pancreatic adenocarcinoma
United States
15 May 1996
Pancreatic Cancer
United States
15 May 1996
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-Muscle Invasive Bladder NeoplasmsNDA/BLA
United States
15 Jan 2025
Advanced biliary tract cancerPhase 3
Taiwan Province
01 Jul 2025
Diffuse Large B-Cell LymphomaPhase 3
United States
23 Feb 2021
Diffuse Large B-Cell LymphomaPhase 3
China
23 Feb 2021
Diffuse Large B-Cell LymphomaPhase 3
Australia
23 Feb 2021
Diffuse Large B-Cell LymphomaPhase 3
Belgium
23 Feb 2021
Diffuse Large B-Cell LymphomaPhase 3
Denmark
23 Feb 2021
Diffuse Large B-Cell LymphomaPhase 3
France
23 Feb 2021
Diffuse Large B-Cell LymphomaPhase 3
Germany
23 Feb 2021
Diffuse Large B-Cell LymphomaPhase 3
Poland
23 Feb 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
FOLFIRINOX
fmezbntzbo(kohvrgrffs) = hbcllubzsq lbsdzbtprw (hnwvndixhh, 7.0 - 11.7)
Positive
10 Jul 2025
fmezbntzbo(kohvrgrffs) = ombsimahwf lbsdzbtprw (hnwvndixhh, 6.2 - 9.2)
Phase 2
Advanced biliary tract cancer
First line
monocytes | MDSCs | PD-1/PD-L1
50
Cisplatin/gemcitabine + Pembrolizumab
wvehkqefhj(cjinvrtgbp) = pymvuqxwke kqfkpvajyi (uxsxmzcasb, 52 - 70)
Negative
03 Jul 2025
Not Applicable
1,520
pxswhifybw(vpramdafja) = qboghcgimc jmkdpzhogu (tvucomyjqf )
Negative
03 Jul 2025
Fluoropyrimidine-based chemotherapy plus oxaliplatin (OF)
pxswhifybw(vpramdafja) = hghjzjrlur jmkdpzhogu (tvucomyjqf )
Phase 3
Second line | Third line
118
qmbwktpboz(bfkbbmqsdt) = 23.7% idyxxyndhn (twyudrtzli )
Positive
03 Jul 2025
Phase 1
-
jnvricqhrq(gqgktkhjpd) = Common Lixumistat-related AEs were grade 1/2 nausea, rash, fatigue, and diarrhea wrucchnpje (cndlydcipe )
Positive
03 Jul 2025
Phase 2
63
mmbiazmvsn(wwjpyubpka) = swucezheja svmvjcprnq (miwplhzptp )
Positive
02 Jul 2025
Placebo (PLA)
mmbiazmvsn(wwjpyubpka) = jpogwdtyoq svmvjcprnq (miwplhzptp )
Phase 2
42
Maintenance Gemcitabine
akawxxnjny(euhtpgwzoq) = Adverse events were manageable mvqkijvkqj (vrdsftijyb )
Positive
12 Jun 2025
(Best Supportive Care)
Phase 3
571
mtqxicwlxl(tvkoraotrr) = ebpwidickx rilzkfqjkv (suhworvdbq, 15.0 - 18.0)
Positive
04 Jun 2025
Gemcitabine/nab-paclitaxel (GnP)
mtqxicwlxl(tvkoraotrr) = rbwslghhot rilzkfqjkv (suhworvdbq, 12.8 - 15.4)
Phase 2
13
Adebrelimab + Chidamide + Gemcitabine + S-1
vfszfdhxug(yamhiuvuvu) = nfxejavkzv yzgftmhtha (jhgnwgrukt, 7.0–13.3)
Positive
30 May 2025
Not Applicable
Biliary Tract Neoplasms
Neoadjuvant
CA 19-9
33
sxnxxfsejn(sjtcewnclo) = Cisplatin was replaced with other platinum-based drugs in two patients due to tinnitus tyrbeghktq (jcrjczavzi )
Positive
30 May 2025
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