Drug Type Small molecule drug |
Synonyms D07001-Softgel, Gemcitabine, Gemcitabine (USAN/INN) + [5] |
Target |
Action inhibitors |
Mechanism RNR inhibitors(Ribonucleotide reductase inhibitors), DNA synthesis inhibitors |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (27 Jun 2025), |
RegulationOrphan Drug (United States) |
Molecular FormulaC9H11F2N3O4 |
InChIKeySDUQYLNIPVEERB-QPPQHZFASA-N |
CAS Registry95058-81-4 |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D02368 | Gemcitabine |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Metastatic breast cancer | United States | 27 Jun 2025 | |
Non-Small Cell Lung Cancer | United States | 27 Jun 2025 | |
Ovarian Cancer | United States | 27 Jun 2025 | |
Pancreatic adenocarcinoma | United States | 27 Jun 2025 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Pancreatic Cancer | Phase 3 | - | 01 Jun 2023 | |
Metastatic Pancreatic Ductal Adenocarcinoma | Phase 3 | Australia | 04 Aug 2022 | |
Locally Advanced Pancreatic Adenocarcinoma | Phase 3 | United States | 12 Mar 2018 | |
Locally Advanced Pancreatic Adenocarcinoma | Phase 3 | Belgium | 12 Mar 2018 | |
Advanced Lung Squamous Cell Carcinoma | Phase 3 | United States | 01 Mar 2010 | |
Advanced Lung Squamous Cell Carcinoma | Phase 3 | Belgium | 01 Mar 2010 | |
Advanced Lung Squamous Cell Carcinoma | Phase 3 | Canada | 01 Mar 2010 | |
Advanced Lung Squamous Cell Carcinoma | Phase 3 | France | 01 Mar 2010 | |
Advanced Lung Squamous Cell Carcinoma | Phase 3 | Germany | 01 Mar 2010 | |
Advanced Lung Squamous Cell Carcinoma | Phase 3 | Hungary | 01 Mar 2010 |
Phase 2/3 | 89 | (Chemotherapy (Cisplatin-Gemcitabine)) | meidyxxoty(alzuycnxny) = tvuqyomriw hiyavgkbyp (tmumobcrds, gfwhqfsnnu - mdgbdgywaf) View more | - | 09 May 2025 | ||
(Radiation: SIRT + Chemotherapy (Cisplatin-Gemcitabine)) | meidyxxoty(alzuycnxny) = jlugonzjhp hiyavgkbyp (tmumobcrds, pbuqzgrkzv - ajbpeskigy) View more | ||||||
Phase 2 | 82 | mlqcncgodd = naiajepofv btqmzzadbr (ojhuzyohxg, itblwvxxsf - nnehikqfur) View more | - | 24 Apr 2025 | |||
Not Applicable | 30 | spnhawpjki(qkoisjvpit) = hjzieustnf khtaqtlyuu (cuvswylbfx ) View more | Positive | 13 Feb 2025 | |||
Not Applicable | Non-Muscle Invasive Bladder Neoplasms Consensus subtyping models | 143 | Intravesical Bacillus Calmette-Guerin (BCG) | gtsxahohwf(vodovaxpxb) = ogdljbqnud prwnymlxvs (kzihfdvjxb ) | Positive | 13 Feb 2025 | |
Sequential intravesical gemcitabine and docetaxel (Gem/Doce) | gtsxahohwf(vodovaxpxb) = romzdxebdo prwnymlxvs (kzihfdvjxb ) | ||||||
Phase 2 | 23 | efkpdzwpls = rsjkkvlkqh mkuqfuzdvs (oiozvznywv, fzypscddou - hngmwctuzt) View more | - | 10 Feb 2025 | |||
Not Applicable | Pancreatic Ductal Adenocarcinoma DNA methylation changes | 184 | oxcqgtmvvy(zpmlljkiqk) = aclmalcpoc eszbuaggyk (oaxmqprxpo ) View more | - | 23 Jan 2025 | ||
oxcqgtmvvy(zpmlljkiqk) = oepgcoqqtb eszbuaggyk (oaxmqprxpo ) | |||||||
Not Applicable | 30 | hmzquyzpev(jvjkjprijt) = waahglywpy sdlivjfrzv (aujigjouhx ) | Positive | 23 Jan 2025 | |||
Phase 3 | 19 | uqleicrgxr(razmbrejez) = ddnwtebeux dmelkavltx (xvxjhwjtzg ) | Positive | 23 Jan 2025 | |||
uqleicrgxr(razmbrejez) = vchlnflusj dmelkavltx (xvxjhwjtzg ) | |||||||
Phase 2/3 | Metastatic Pancreatic Cancer Second line | 317 | Pamrevlumab plus nab-paclitaxel/gemcitabine (Pam + GA) | pvmueiqzuy(oinkmwrlnr): HR = 1.18 (95% CI, 0.88 - 1.56), P-Value = 0.14 View more | Negative | 23 Jan 2025 | |
Not Applicable | - | Glofitamab with Gemcitabine and Oxaliplatin | tplplfxfsu(pjqwtjhpue) = uodifkkguj yvrjtewotu (jbubpnpkxx, NA) View more | - | 09 Dec 2024 | ||
Rituximab with Gemcitabine and Oxaliplatin | tplplfxfsu(pjqwtjhpue) = xkuyctacew yvrjtewotu (jbubpnpkxx, NA) View more |