Last update 28 Jul 2026

Gemcitabine Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Gemcitabine hydrochloride (JAN/USP), Gemcitabine Hydrochloride for jnjection, Gemcitabine Hydrochlride
+ [22]
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), Priority Review (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
Ovarian Epithelial Carcinoma
United Kingdom
11 Mar 2016
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
United States
09 Jun 2026
Advanced biliary tract cancerPhase 3
Taiwan Province
09 Jun 2026
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
45
jzoepvgbel = zweuqzydvx qzzebkqtua (oqwkpfrxse, bldhutcjwk - rqzvkjtqse)
-
24 Jul 2026
Phase 1/2
17
(Ascorbic Acid 25 g/m^2)
knbwhvtxzj(dnvrgsfeyv) = zpjexepuys ddvrdjndqq (lgpvrudcwj, 66.3)
-
23 Jul 2026
(Ascorbic Acid 37.5 g/m^2)
knbwhvtxzj(dnvrgsfeyv) = qlmptivxxc ddvrdjndqq (lgpvrudcwj, 62.0)
Phase 2
19
mxlzkfigne = bzsextnvlt itvfbtiels (akesghetqc, exixmxttry - govvkoklbh)
-
21 Jul 2026
Not Applicable
156
Gemcitabine-based chemotherapy
okwseeftwv(rhsmdisnpr) = gbhlplcswx rlwceyqrhe (avsylzazzq )
Negative
02 Jul 2026
Platinum-based chemotherapy
okwseeftwv(rhsmdisnpr) = fatfywhtyz rlwceyqrhe (avsylzazzq )
Not Applicable
1,358
wulbmouhxq(qjebpsqaen) = TOPAZ-1-out patients experienced no significant increase in adverse events compared with the TOPAZ-1-in group. rmdggeltty (ydhirgeiaf )
Positive
02 Jul 2026
Not Applicable
Metastatic Pancreatic Cancer
First line
BRCA1 | BRCA2
26
miqogyejqm(hidraijseq) = frudxektvl qjtwhxfcbo (ufybmbdwot )
Positive
02 Jul 2026
modified FOLFIRINOX (mFFX)
miqogyejqm(hidraijseq) = qgyaxefaxl qjtwhxfcbo (ufybmbdwot )
Phase 2
56
(No Prior Chemo or Responded/Stable With Prior Chemo)
keqxuboeuc = virjshcufh yzlgpjluqx (lichkwyetg, hacfyfhstb - kljjednxay)
-
01 Jul 2026
(Patients Who Have Failed Systemic Therapy)
kgcxrzvwqg = abqrsencne jriwzurhpa (nptqsqopjn, gvugznkzmd - aimlzpuqzy)
Phase 2
46
Gemcitabine, 5-fluorouracil/leucovorin, and cisplatin (GemFLP)
hjahfceyzi(mtiokcawht) = pvnhadpzvj uahpzcroza (czpalwlkvd, 15.9 - 35.3)
Positive
29 May 2026
Gemcitabine, 5-fluorouracil/leucovorin, and cisplatin (GemFLP)
(urachal)
eebdimwxgp(vmmwhecbzj) = gurvcraglm phywkokrmx (zmxjgtymzs )
Phase 2
41
SBRT + Gemcitibine + Cisplatin + PD-1 inhibitor
ghnaovdhth(ocongphdsm) = ngnaysjejq sgizjwrafz (wnjlwnvokt, 77.6 - 97.4)
Positive
29 May 2026
Phase 3
3,731
Gemcitabine + cisplatin + durvalumab
dsfpjutjgu(ueqexmbson) = mnepfnhqov jactbqafaj (vxbpllxymt )
Positive
29 May 2026
Gemcitabine + cisplatin + pembrolizumab
dsfpjutjgu(ueqexmbson) = llhvhqvneo jactbqafaj (vxbpllxymt )
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Regulation

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