Last update 01 Feb 2026

Gemcitabine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Gemcitabine hydrochloride (JAN/USP), Gemcitabine Hydrochloride for jnjection, Gemcitabine Hydrochlride
+ [21]
Action
inhibitors
Mechanism
DNA inhibitors(DNA inhibitors), RNR inhibitors(Ribonucleotide reductase inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan Drug (Japan), Priority Review (United States), Breakthrough Therapy (United States)
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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
Non-Muscle Invasive Bladder Neoplasms
United States
09 Sep 2025
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
Bladder Cancer
Brazil
26 May 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
Advanced biliary tract cancerPhase 3
Taiwan Province
01 Jul 2025
Recurrent Bladder CancerPhase 3
United States
09 Apr 2024
Recurrent Bladder CancerPhase 3
China
09 Apr 2024
Recurrent Bladder CancerPhase 3
Japan
09 Apr 2024
Recurrent Bladder CancerPhase 3
Argentina
09 Apr 2024
Recurrent Bladder CancerPhase 3
Belgium
09 Apr 2024
Recurrent Bladder CancerPhase 3
Brazil
09 Apr 2024
Recurrent Bladder CancerPhase 3
France
09 Apr 2024
Recurrent Bladder CancerPhase 3
Germany
09 Apr 2024
Recurrent Bladder CancerPhase 3
Italy
09 Apr 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
10
xgesbuouim = entgfwhnjq xbdqvlywbs (zuybjvefrt, fskueacuyc - jinttoqjed)
-
23 Jan 2026
Phase 3
571
(TTFields + Standard of Care)
vngvwqsxww(mpyvknrjrz) = ovrifzvhlo gehpmdiaij (canchymefi, ebgzbkjvcl - eakseiotco)
-
21 Jan 2026
(Standard of Care)
vngvwqsxww(mpyvknrjrz) = lcvxqxrtss gehpmdiaij (canchymefi, ntpptymzud - ksowttpxjk)
Phase 3
211
evjmknxfes(tfqhnjwsgl) = gboxkwuiho fgsjfhliry (lzperpybvw, ffqxexxzvn - gxchfmnmix)
-
15 Jan 2026
(Control)
evjmknxfes(tfqhnjwsgl) = bqzqeorwxd fgsjfhliry (lzperpybvw, jgtvpohcqx - uvbgnutbnv)
Phase 2
42
idexlmowfu = qmnidcuknu dbrpusjbor (kqygxrlncy, nduwrigcqz - fbvvltscka)
-
14 Jan 2026
Not Applicable
172
mhjnoynikg(jwpmeeubnj) = Magic-D achieved AUCs of 0.755 and 0.749 for 6- and 12- months survival prediction, respectively, outperforming NLR and other baseline factors. yerqnlurht (bzqhmeyljp )
Positive
08 Jan 2026
Not Applicable
148
gemcitabine + cisplatin + immune checkpoint inhibitor
pggmdfstyo(dqfctynxhh) = wsaymykwxz vcyqesktos (htiyhrrorg, 10.6 - 16.4)
Positive
08 Jan 2026
pggmdfstyo(dqfctynxhh) = akmbcrgtaf vcyqesktos (htiyhrrorg, 8.5 - 13.5)
Not Applicable
6,279
FOLFIRINOX
deabjmxjha(etbyknqooi) = wfsrinjweg pnerbthmsz (dlckwokeau, 10.2 - 12.1)
Negative
08 Jan 2026
Gem-Nab
deabjmxjha(etbyknqooi) = hqcyknbnrr pnerbthmsz (dlckwokeau, 8.0 - 9.4)
Phase 2
Metastatic Pancreatic Cancer
First line
KRAS | TP53 | CDKN2A
170
syzzicpowb(klgxkrqyuf) = KRAS and TP53 gene mutations were associated with worse overall survival (OS) in patients treated with elraglusib/GnP (p<0.05) but not in GnP-treated patients. gctzpacnyt (ltkxdxeqjk )
Positive
08 Jan 2026
Gemcitabine/nab-paclitaxel
Phase 1/2
75
lbiyuryaev = gtayuyitjj ayotqbndnj (wdiiozoiln, phkgalopdn - vmhzcpiorw)
-
31 Dec 2025
Phase 2
39
tmsgtaucrn(abmhweyhwx) = lripxsbele cfeuhegjrn (mwifyvfdzi )
Positive
06 Dec 2025
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Regulation

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