Overview
Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers. Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl on the ribose. As a prodrug, gemcitabine is transformed into its active metabolites that work by replacing the building blocks of nucleic acids during DNA elongation, arresting tumour growth and promoting apoptosis of malignant cells. The structure, metabolism, and mechanism of action of gemcitabine are similar to cytarabine, but gemcitabine has a wider spectrum of antitumour activity. Gemcitabine is marketed as Gemzar and it is available as intravenous injection. It is approved by the FDA to treat advanced ovarian cancer in combination with carboplatin, metastatic breast cancer in combination with paclitaxel, non-small cell lung cancer in combination with cisplatin, and pancreatic cancer as monotherapy. It is also being investigated in other cancer and tumour types.
Indication
Gemcitabine is a chemotherapeutic agent used as monotherapy or in combination with other anticancer agents. In combination with carboplatin, it is indicated for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. Gemcitabine in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. In combination with cisplatin, gemcitabine is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). Dual therapy with cisplatin is also used to treat patients with Stage IV (locally advanced or metastatic) transitional cell carcinoma (TCC) of the bladder. Gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with fluorouracil.
Associated Conditions
- Advanced Ovarian Cancer
- Bladder Transitional Cell Carcinoma Stage IV
- Carcinoma of the Head and Neck
- Cervical Cancer
- Cutaneous T-Cell Lymphoma (CTCL)
- Hodgkins Disease (HD)
- Mesothelioma
- Metastatic Breast Cancer
- Pancreatic Adenocarcinoma Locally Advanced
- Small Cell Lung Cancer (SCLC)
- Stage IIIA Non Small Cell Lung Cancer
- Stage IIIB Non-Small Cell Lung Cancer
- Stage IV Non-small Cell Lung Cancer (NSCLC)
- Stage 4 Pancreatic adenocarcinoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/03 | Not Applicable | Not yet recruiting | |||
2025/06/29 | Not Applicable | Not yet recruiting | |||
2025/06/29 | Not Applicable | Not yet recruiting | |||
2025/06/22 | Phase 2 | Not yet recruiting | Jinbo Yue | ||
2025/06/19 | Phase 2 | Not yet recruiting | GERCOR - Multidisciplinary Oncology Cooperative Group | ||
2025/06/17 | Phase 1 | Not yet recruiting | |||
2025/06/15 | Phase 2 | Not yet recruiting | Michael Spinner, MD | ||
2025/06/13 | Phase 2 | Recruiting | Ekaterina Laukhtina | ||
2025/06/06 | Phase 1 | Recruiting | |||
2025/06/05 | Phase 2 | Recruiting | TJ Biopharma Co., Ltd. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hospira, Inc. | 0409-0185 | INTRAVENOUS | 38 mg in 1 mL | 10/21/2019 | |
| Armas Pharmaceuticals Inc. | 72485-222 | INTRAVENOUS | 1 g in 26.3 mL | 1/10/2020 | |
| Accord Healthcare Inc. | 16729-391 | INTRAVENOUS | 100 mg in 1 mL | 11/5/2022 | |
| Accord Healthcare Inc. | 16729-426 | INTRAVENOUS | 100 mg in 1 mL | 11/5/2022 | |
| Armas Pharmaceuticals Inc. | 72485-221 | INTRAVENOUS | 200 mg in 5.26 mL | 1/10/2020 | |
| Hospira, Inc. | 0409-0181 | INTRAVENOUS | 38 mg in 1 mL | 6/30/2019 | |
| Fresenius Kabi USA, LLC | 63323-125 | INTRAVENOUS | 1 g in 25 mL | 12/17/2019 | |
| Mylan Institutional LLC | 67457-617 | INTRAVENOUS | 1 g in 26.3 mL | 12/18/2019 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9394 | INTRAVENOUS | 200 mg in 1 1 | 6/28/2021 | |
| Cipla USA Inc. | 69097-314 | INTRAVENOUS | 1 g in 25 mL | 9/14/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GEMITA LYOPHILISED POWDER FOR SOLUTION FOR INJECTION 200 mg/vial | SIN14925P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 mg/vial | 1/25/2016 | |
| GEMZAR 200mg Powder for Solution for Infusion | SIN09416P | INJECTION, POWDER, FOR SOLUTION | 200mg | 7/23/1997 | |
| FONKO-GEMCITABINE LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION 200MG/VIAL | SIN16771P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200mg/vial | 5/3/2023 | |
| GEMZAR 1gm POWDER FOR SOLUTION FOR INFUSION | SIN13229P | INJECTION, POWDER, FOR SOLUTION | 1000mg | 12/22/2006 | |
| GEMIBINE-200 POWDER FOR SOLUTION FOR INFUSION 200 MG VIAL | SIN15554P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 mg | 9/28/2018 | |
| GEMITA LYOPHILISED POWDER FOR SOLUTION FOR INJECTION 1 g/vial | SIN14926P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1 g/vial | 1/25/2016 | |
| GEMITA® CONCENTRATE FOR SOLUTION FOR INFUSION 38MG/ML | SIN15887P | INFUSION, SOLUTION CONCENTRATE | 38mg/ml | 2/20/2020 | |
| GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 200MG/VIAL | SIN14559P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 mg | 6/12/2014 | |
| GEMIBINE-1000 POWDER FOR SOLUTION FOR INFUSION 1 G VIAL | SIN15553P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1000.00 mg | 9/28/2018 | |
| GEMTERO (GEMCITABINE HYDROCHLORIDE) FOR INJECTION 1G/VIAL | SIN14558P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1000 mg | 6/12/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Gemcitabine Hydrochloride for Injection | 国药准字H20113285 | 化学药品 | 注射剂 | 3/22/2021 | |
| Gemcitabine Hydrochloride for Injection | 国药准字H20249831 | 化学药品 | 注射剂 | 12/25/2024 | |
| Gemcitabine Hydrochloride for Injection | 国药准字H20123340 | 化学药品 | 注射剂 | 9/18/2022 | |
| Gemcitabine Hydrochloride for Injection | 国药准字H20143001 | 化学药品 | 注射剂 | 1/3/2024 | |
| Gemcitabine Hydrochloride for Injection | 国药准字H20233706 | 化学药品 | 注射剂 | 6/14/2023 | |
| Gemcitabine Hydrochloride for Injection | 国药准字H20103523 | 化学药品 | 注射剂(粉针剂) | 6/22/2020 | |
| Gemcitabine Hydrochloride for Injection | 国药准字H20203645 | 化学药品 | 注射剂 | 12/8/2020 | |
| Gemcitabine Hydrochloride for Injection | 国药准字H20093404 | 化学药品 | 注射剂 | 12/5/2023 | |
| Gemcitabine Hydrochloride for Injection | 国药准字H20253258 | 化学药品 | 注射剂 | 1/24/2025 | |
| Gemcitabine Hydrochloride for Injection | 国药准字H20233420 | 化学药品 | 注射剂 | 4/4/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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