Gemcitabine
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | GEMZAR | — | 1998-08-25 – 2006-07-14 | fda.gov ↗ |
| Approved | US (FDA) | GEMZAR | — | 1996-05-15 | fda.gov ↗ |
Trials 1,933 · started per year
Press releases naming this drug 97 releases
Evidence & citations 31 cited values
Every value below carries the sentence it was read from. 3,248 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | gemcitabine | “including but not limited to DHAP (dexamethasone, cisplatin, high-dose cytarabine), ESHAP (etoposide, methylprednisolone, high-dose cytarabine and cisplatin), DICE...” NCT04486391 ↗3107“Any of the following single-agent chemotherapy may be given at the discretion of the investigator, with a cycle length not to exceed four weeks: Capecitabine, Vinorelbine,...” NCT01156753 ↗ “Participants will receive 6 cycles of a standard intravenous or oral chemotherapy regimen or an Antibody-Drug Conjugate (ADC), selected by the investigator from...” NCT07371910 ↗ “Gemcitabine will be administered at a calculated dose of 800 mg/m2/BSA every 21 days as concomitant therapy to Nimotuzumab, until 6 cycles are completed, exclusion or death...” NCT02095119 ↗ “Acceptable histology-specific PDC regimens include carboplatin plus paclitaxel or nab-paclitaxel (any histology), carboplatin/cisplatin plus pemetrexed (nonsquamous),...” NCT06865339 ↗ “First-line chemotherapy regimen: gemcitabine combined with albumin-bound paclitaxel or FOLFIRINOX; second-line chemotherapy regimen: If first-line chemotherapy based on...” NCT04677192 ↗ “Successful organoids undergo drug sensitivity testing against a predefined panel of drugs (Gemcitabine + Cisplatin,Gemcitabine + Oxaliplatin,Durvalumab + Gemcitabine +...” NCT07351591 ↗ “Either Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on...” NCT04421547 ↗ “The cohort A (borderline resectable) and cohort B (locally advanced) both received treatment with gemcitabine, albumin paclitaxel (administered on days 1, 8, and 15, with 4...” NCT07208539 ↗ “Gemcitabine + oxaliplatin (GEMOX) regimen chemotherapy: every 21 days (3 weeks), 1000 mg/m2 of gemcitabine was administered intravenously for more than 30 min on the 1st and...” NCT06362317 ↗ “Tivantinib 360 mg twice daily in combination with other anti-cancer therapy (eg, erlotinib,sorafenib, pemetrexed, docataxel, gemcitabine, irinotecan, and/or cetuximab) at the...” NCT01178411 ↗ |
| Known as | 2',2'-difluorodeoxycytidine | “CP-4126 is a gemcitabine (2',2'-difluorodeoxycytidine; dFdC) 5' elaidic acid ester.” PMID 23345000 ↗ Jan 20131“Gemcitabine [2', 2' -Difluorodeoxycytidine]” NCT00217477 ↗ |
| Known as | 29,29-difluoro 29-deoxycytidine | “Gemcitabine (29,29-difluoro 29-deoxycytidine, dFdC) which developed from cytosine arabinoside (Ara-C) is an nucleoside analog used as chemotherapy.” NCT02761291 ↗ |
| Known as | dFdC | “Gemcitabine (29,29-difluoro 29-deoxycytidine, dFdC) which developed from cytosine arabinoside (Ara-C) is an nucleoside analog used as chemotherapy.” NCT02761291 ↗2“CP-4126 is a gemcitabine (2',2'-difluorodeoxycytidine; dFdC) 5' elaidic acid ester.” PMID 23345000 ↗ Jan 2013 “dFdC” NCT06064097 ↗ |
| Known as | difluorodeoxycytidine | “Gemcitabine (difluorodeoxycytidine) is active as a single agent in Hodgkin's disease and has been used successfully in combination with cisplatin to treat a variety of solid tumors.” PMID 14630682 ↗ Dec 2003 |
| Known as | GEM | “PURPOSE: Here we report a phase II clinical trial, which was designed to test a novel hypothesis that treatment with gemcitabine (GEM)/doxorubicin (DOX) would be efficacious...” PMID 21791630 ↗ Jul 201137“PURPOSE: This randomized phase-II trial (ClinicalTrials.gov identifier: NCT02767557) compared efficacy of gemcitabine/nab-paclitaxel (Gem/Nab) with or without the...” PMID 40354592 ↗ May 2025 “This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma...” NCT00127595 ↗ “This study will use imaging to look at tumor response to combination chemotherapy of gemcitabine (Gem) and cisplatin (Cis) or gemcitabine and carboplatin (Carbo) in non small...” NCT00599755 ↗ “This open-label, multicenter, randomised phase II trial evaluated gemcitabine plus afatinib (Gem/afatinib) versus gemcitabine (Gem) alone as first-line treatment for metastatic...” PMID 33588150 ↗ Feb 2021 “Gemcitabine (GEM) is a synthetic nucleoside derivative of cytosine, which mainly acts on S phase and has been used in solid tumors for more than 20 years.” NCT05189028 ↗ “Participants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m\^2) (30 minutes) on Days 1 and 8 of each 21-day cycle.” NCT02393248 ↗ “SINE compounds synergize with gemcitabine (GEM) and nanoparticle albumin-bound (nab)-paclitaxel leading to suppression of PDAC cellular growth” PMID 31831564 ↗ Dec 2019 “ABX (Abraxane) 125 mg/m2，intravenous infusion，30min，day 1, 8, 15 GEM (Gemcitabine) 800 mg/m2，intravenous infusion，30min，day 1, 8, 15” NCT01550848 ↗ “gemcitabine hydrochloride (GEM) + alpha-type-1 dendritic cell (αDC1)-tumor blood vessel antigen (TBVA) vaccination” NCT02479230 ↗ “Gemcitabine (Gem) will be administered at a dose of 1250 mg/m\^2 as intravenous infusion on Days 1 and 8.” NCT00842712 ↗ |
| Known as | Gemcitabin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06274879 ↗ |
| Known as | Gemcitabina | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00758381 ↗ |
| Known as | Gemcitabine (Gemzar, Lily Inc.) | “Gemcitabine (Gemzar®, Lily Inc.)” NCT00695994 ↗ |
| Known as | Gemcitabine - Gemcitane | “Gemcitabine - Gemcitane” NCT01096745 ↗ |
| Known as | gemcitabine HCl | “when it is used with another FDA-approved cancer treatment (chemotherapy) drug called gemcitabine HCl (pronounced "gem-site-a-bean"; its brand name is GEMZAR®.” NCT00363610 ↗ |
| Known as | Gemcitabine HCl Oral Formulation | “Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period” NCT01678690 ↗ |
| Known as | Gemcitabine Hydrochloride | “To determine the maximum tolerated dose and recommended phase II dose of dovitinib (dovitinib lactate) when administered concurrently with gemcitabine (gemcitabine...” NCT02048943 ↗229“The purpose of this research study is to find out what effects, good and/or bad, dose-dense (every 14 days) chemotherapy with gemcitabine (gemcitabine hydrochloride) and...” NCT01611662 ↗ “PRIMARY OBJECTIVES: I. To estimate the antitumor activity of gemcitabine hydrochloride in patients with persistent or recurrent endometrial adenocarcinoma who have failed...” NCT00820898 ↗ “Compare the incidence of venous thromboembolism in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and dalteparin versus...” NCT00462852 ↗ “Determine the incidence and nature of acute and late toxicity of gemcitabine hydrochloride, cisplatin, and concurrent radiotherapy in patients with stage II or III transitional...” NCT00556621 ↗ “Drugs used in chemotherapy, such as gemcitabine hydrochloride and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by...” NCT01041781 ↗ “This pilot clinical trial studies combination chemotherapy and radiation therapy before surgery followed by gemcitabine hydrochloride in treating patients with pancreatic cancer.” NCT01821612 ↗ “To establish the maximum tolerated dose of gemcitabine hydrochloride delivered via bronchial artery infusion in patients with recurrent or progressive non-small cell lung cancer.” NCT00619021 ↗ “Determine the safety of adjuvant, fixed-dose rate gemcitabine hydrochloride and bevacizumab in patients with completely resected pancreatic cancer.” NCT00410774 ↗ “Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells” NCT01298401 ↗ “Gemcitabine hydrochloride, cell cycle-specific antimetabolites, mainly acting on tumor cells in the DNA synthesis phase (S phase cell).” NCT05198531 ↗ |
| Known as | Gemcitabine Hydrochloride for Injection | “Gemcitabine Other Name: Gemcitabine Hydrochloride for Injection” NCT04181645 ↗2“Gemcitabine Hydrochloride for injection.” NCT07229586 ↗ “Gemcitabine Hydrochloride for Injection” NCT04568304 ↗ |
| Known as | Gemcitabine Injectable Product | “Drug: Gemcitabine Injectable Product” NCT04331626 ↗ |
| Known as | Gemcitabine Injection | “This study is to analyze the safety and efficacy of immunotherapy Triprilumab Injection combined with Gemcitabine Injection plus Cisplatin Injection in patients with advanced...” NCT04413734 ↗ |
| Known as | Gemcitabine ；gemzer | “Gemcitabine ；gemzer” NCT02272738 ↗ |
| Known as | Gemcitabine/Gemzar | “gemcitabine (Gemzar)” NCT01834235 ↗8“Gemcitabine (Gemzar)” NCT03415854 ↗ “Gemcitabine (Gemzar)” NCT04989218 ↗ “Gemcitabine - Gemzar” NCT00709826 ↗ “Gemcitabine (Gemzar)” NCT03138720 ↗ “Gemcitabine: Gemzar” NCT01648517 ↗ “Gemcitabine- Gemzar” NCT01434459 ↗ “Gemcitabine/Gemzar” NCT00517595 ↗ “gemcitabine:Gemzar” NCT01424709 ↗ |
| Known as | Gemzar | “The purpose of this study is to determine whether a new chemotherapy schedule using biweekly combination of paclitaxel (Taxol®), gemcitabine (Gemzar®) and Avastin would help to...” NCT00618826 ↗40“The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily...” NCT00226746 ↗ “Gemcitabine (Gemzar®), 1000 mg/m2 in 0.9% sodium chloride will be administered as intravenous infusion over 30 minutes, weekly for 3 weeks then rest for 1 week (days 1, 8, 15...” NCT01547260 ↗ “14 days after II look-TURB the patients received 6 weekly instillations of Gemcitabine (Gemzar, Eli Lilly SpA), using a dose of 2000 mg diluted in 50 mL of saline held in the...” NCT00696579 ↗ “This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.” NCT00225784 ↗ “A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium” NCT00310011 ↗ “when it is used with another FDA-approved cancer treatment (chemotherapy) drug called gemcitabine HCl (pronounced "gem-site-a-bean"; its brand name is GEMZAR®.” NCT00363610 ↗ “When the core body temperature reaches 104oF (40oC), a 30-minute (IV) infusion of another chemotherapy drug, gemcitabine (Gemzar) is given.” NCT00178698 ↗ “Many combinations with gemcitabine have been evaluated but have shown no significant survival advantage over Gemzar alone.” NCT05065801 ↗ “A Phase II Trial of Gemzar (Gemcitabine) and Gleevec (Imatinib Mesylate) in Patients With Metastatic Renal Cell Carcinoma” NCT00323791 ↗ “A Phase I/II Study Using Cisplatin and Gemcitabine (Gemzar) for Advanced Head and Neck Cancer (Squamous Cell Carcinoma)” NCT00003182 ↗ |
| Known as | Gemzar (Gemcitabine) | “Gemzar ( gemcitabine)” NCT00375310 ↗5“Gemzar (Gemcitabine)” NCT01900158 ↗ “Gemzar (Gemcitabine)” NCT01320254 ↗ “gemzar - gemcitabine” NCT00808145 ↗ “Gemzar (gemcitabine)” NCT01621243 ↗ “Gemzar(Gemcitabine)” NCT01236716 ↗ |
| Known as | gemzer | “Other Names:
Gemcitabine； gemzer” NCT01917617 ↗1“Gemcitabine;gemzer , S-1;TS-1” NCT01713387 ↗ |
| Known as | Generic name: gemcitabine; Brand name: Gemzar | “Generic name: gemcitabine; Brand name: Gemzar ®” NCT02769832 ↗ |
| Known as | intravesical Chemotherapy docetaxel/gemcitabine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06972615 ↗ |
| Known as | L01BC05 Gemcitabine | “L01BC05 Gemcitabine” NCT05738161 ↗ |
| Known as | NSC-613327 | “Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.” NCT00001431 ↗ |
| Known as | ST-02 | “The goal of this prospective clinical trial is to investigate the safety and efficacy of ST-02 (mucoadhesive gemcitabine suspension for pyelocaliceal instillation) to treat...” NCT06124976 ↗ |
| Known as | TAR-200 | “The TAR-200/ gemcitabine (JNJ-17000139) product is an intravesical drug delivery system regulated as an investigational drug.” NCT04919512 ↗ |
| Known as | TAR-200/gem-iDRS | “neoadjuvant gemcitabine intravesical system (TAR-200/gem-iDRS) plus cetrelimab or cetrelimab monotherapy in patients with MIBC.” PMID 41337691 ↗ Dec 2025 |
| Action | Inhibit | “DNA synthesis is inhibited by gemcitabine by masked chain termination and via inhibition of ribonucleotide reductase.” PMID 10442378 ↗ Jul 1999 |
| Modality | Small molecule | “Gemcitabine (Gemzar) is a nucleoside analog” PMID 10442378 ↗ Jul 1999 |
| Route | Intravenous | “gemcitabine IV over 30 minutes” NCT00002998 ↗ |