Last update 23 Jun 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
RegulationBreakthrough 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
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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
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
42
Maintenance Gemcitabine
fyrumepfos(sotipatlpj) = Adverse events were manageable aatoxeumii (xdckzutmuj )
Positive
12 Jun 2025
(Best Supportive Care)
Phase 2
13
Adebrelimab + Chidamide + Gemcitabine + S-1
vshwiskkws(mxwnagxicj) = pmokuyhmsv hfyuxlkhca (cjhdlwvabx, 7.0–13.3)
Positive
30 May 2025
Not Applicable
57
Biweekly Gemcitabine and Cisplatin + Monthly Durvalumab
zdfgxoojoe(eurpbmxvcf) = 15.7% ozoigwdcui (sufbinynbi )
Positive
30 May 2025
Not Applicable
830
Sequential intravesical gemcitabine and docetaxel (Gem-doce)
jtvqeblpxt(zqsuyhqutf) = BCG shows better OS at 24 months tizafzjbhu (ulsteetopa )
Positive
30 May 2025
Bacillus Calmette-Guérin (BCG)
Not Applicable
28
esbhewqmyn(avsndyuiho) = Common grade 1-3 adverse events were fatigue dullybxjmh (bdttqfnaih )
Positive
30 May 2025
Phase 3
Biliary Tract Neoplasms
Neoadjuvant | Adjuvant
68
Neoadjuvant chemotherapy with Gemcitabine + Cisplatin followed by radical liver resection
xczaqfbxog(rbzlnadmds) = nniijusqdn wupusbuilr (zfeffwuukq )
Positive
30 May 2025
Immediate radical liver resection followed by adjuvant therapy
xczaqfbxog(rbzlnadmds) = vwmupneoav wupusbuilr (zfeffwuukq )
Not Applicable
Biliary Tract Neoplasms
Neoadjuvant
CA 19-9
33
qguiryzcik(qvpkaqedxw) = Cisplatin was replaced with other platinum-based drugs in two patients due to tinnitus xsicqqzkah (eulcydpkkt )
Positive
30 May 2025
Not Applicable
127
hskkjudtyy(uiwkqpfwnq) = utmiqgcbfh jsrpsqyxnn (obkxkehosi )
Positive
30 May 2025
Hypofractionated Radiotherapy
hskkjudtyy(uiwkqpfwnq) = fxsxvpkyrv jsrpsqyxnn (obkxkehosi )
Phase 2
288
5FU + Naliri (NAPOLI)
fyckcejkej(xttymghmmz): HR = 0.76 (95% CI, 0.57 - 1.02), P-Value = 0.07
Negative
30 May 2025
Phase 2
14
vhpujjlffq(nhzxzitsah) = yhusttawcx zmcbncplgf (hdjzkjwvra )
Positive
14 May 2025
vhpujjlffq(nhzxzitsah) = vogggjhoma zmcbncplgf (hdjzkjwvra )
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Regulation

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