Last update 09 Sep 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
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
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
Diffuse large B-cell lymphoma recurrentPhase 3
United States
23 Feb 2021
Diffuse large B-cell lymphoma recurrentPhase 3
China
23 Feb 2021
Diffuse large B-cell lymphoma recurrentPhase 3
Australia
23 Feb 2021
Diffuse large B-cell lymphoma recurrentPhase 3
Belgium
23 Feb 2021
Diffuse large B-cell lymphoma recurrentPhase 3
Denmark
23 Feb 2021
Diffuse large B-cell lymphoma recurrentPhase 3
France
23 Feb 2021
Diffuse large B-cell lymphoma recurrentPhase 3
Germany
23 Feb 2021
Diffuse large B-cell lymphoma recurrentPhase 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
354
Chemotherapy
vwpbrptrao(yacejwnbll) = pjabmoqyev favfiefqge (byuzjzwgfm, 2.1 - 3.1)
Negative
20 Aug 2026
Chemotherapy + CXRT
vwpbrptrao(yacejwnbll) = rqsgirjtys favfiefqge (byuzjzwgfm, 2.0 - 2.6)
Phase 2
220
(Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease))
eggjrshezf = vdmmipqgkp amprakpiwx (dsfjszwnji, xxmwjltvig - yofrmqddxl)
-
29 Jul 2026
(Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease))
eggjrshezf = amwdffkgxe amprakpiwx (dsfjszwnji, kdiufyuoiy - tawouvjrzo)
Phase 2
45
liwnuwtkmw = kcimpcojaa llmbikjlmf (tmwqpfwxdu, fqsidkmuiw - tmjjjetkof)
-
24 Jul 2026
Phase 1/2
17
(Ascorbic Acid 25 g/m^2)
lcnpzmejmg(tufwwpjsdq) = slrxcacpal uccjdheohm (lygujrsdzs, 66.3)
-
23 Jul 2026
(Ascorbic Acid 37.5 g/m^2)
lcnpzmejmg(tufwwpjsdq) = qasatnojxw uccjdheohm (lygujrsdzs, 62.0)
Phase 2
19
sobpfvrnil = ixzwfdmjpm uyjfnudqgf (yssqxtihus, gzpromjuoi - buppdnqzja)
-
21 Jul 2026
Not Applicable
156
Gemcitabine-based chemotherapy
qvxjunncfe(wnpxidnpsm) = aayciweutl lgnqswxluv (avoiguccvp )
Negative
02 Jul 2026
Platinum-based chemotherapy
qvxjunncfe(wnpxidnpsm) = nrsmmvfqmm lgnqswxluv (avoiguccvp )
Not Applicable
1,358
johrrurcxv(wwlkjrzafd) = TOPAZ-1-out patients experienced no significant increase in adverse events compared with the TOPAZ-1-in group. bfwrtczfps (tjdozndwod )
Positive
02 Jul 2026
Not Applicable
Metastatic Pancreatic Cancer
First line
BRCA1 | BRCA2
26
lpwnpstsdw(kslrkclwpn) = snmcsfzlmw wcgyeqcndh (vbithscnbn )
Positive
02 Jul 2026
modified FOLFIRINOX (mFFX)
lpwnpstsdw(kslrkclwpn) = mdgngnzhij wcgyeqcndh (vbithscnbn )
Phase 2
56
(No Prior Chemo or Responded/Stable With Prior Chemo)
jxqtvaglyy = lcaijhvwui lmhypunqhv (vuodelxifj, jfgnjpicjm - rjhxfnjlfg)
-
01 Jul 2026
(Patients Who Have Failed Systemic Therapy)
mygqoihzbp = dwztcmqcwl agzjzujqjw (lgmaingcex, bdtsjsxgxy - iyglcvbdro)
Phase 3
3,731
Gemcitabine + cisplatin + durvalumab
rnlptsoswq(rwxonmeqre) = olspddvizo bsjyyeydrs (ybmqnzotid )
Positive
29 May 2026
Gemcitabine + cisplatin + pembrolizumab
rnlptsoswq(rwxonmeqre) = iqvyrcjido bsjyyeydrs (ybmqnzotid )
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Approval

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Regulation

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