Data updated: Jul 17, 2026
GEMCITABINE · Teva
Trial Activity: Stable 350 active trials
Oncology
Development Insights
Hoffmann-La Roche conducting 39 trials (4%)
946 indications explored (Broad Platform)
→ pancreatic cancer (132 trials)
→ non-small cell lung cancer (38 trials)
→ pancreatic ductal adenocarcinoma (37 trials)
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
GEMCITABINE Approval History
No approval records found
Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
990 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06770582 | NCI-2025-00008 NCI-2025-00008, NRG-GU014 | Ph 2 | recruiting | Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial |
| NCT06498648 | NCI-2024-05665 NCI-2024-05665, 10657 | Ph 1, Ph 2 | recruiting | Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma |
| NCT06050252 | NCI-2023-07031 NCI-2023-07031, 2024-0230 | Ph 2 | recruiting | Testing the Combination of the Anticancer Drug Durvalumab With Chemotherapy (Gemcitabine and Cisplatin) at Improving Outcomes for High-Risk Resectable Liver Cancer Before Surgery |
| NCT03017326 PHITT | RG_15-114 | Ph 3 | active not recruiting | Paediatric Hepatic International Tumour Trial |
| NCT07129993 | DS1062-328 | Ph 2, Ph 3 | recruiting | Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma |
| NCT06524544 | NCI-2024-06208 NCI-2024-06208, EA8231 | Ph 3 | recruiting | A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitean-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer |
| NCT03321643 | NCI-2017-01957 NCI-2017-01957, PHI-96 | Ph 1 | active not recruiting | Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma |
| NCT07504588 | NCI-2026-01998 NCI-2026-01998, NRG-GY038 | Ph 2 | not yet recruiting | Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy |
| NCT04274426 MIROVA | AGO-OVAR 2.34 2018-004207-39, 2024-516959-40-00 | Ph 2 | active not recruiting | Mirvetuximab Soravtansine (IMGN853), in Folate Receptor Alpha (FRα) High Recurrent Ovarian Cancer |
| NCT06843447 | 5909-003 MK-5909-003, 2024-514674-47-00 | Ph 1, Ph 2 | recruiting | A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003) |
| NCT06694454 | 10001609 001609-C | Ph 1, Ph 2 | recruiting | Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC) |
| NCT06029270 | NCI-2023-06678 NCI-2023-06678, NRG-HN011 | Ph 2 | recruiting | Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer |
| NCT06064097 | NCI-2023-07208 NCI-2023-07208, ARAR2221 | Ph 2 | recruiting | A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC) |
| NCT03337698 Morpheus Lung results posted | BO39610 2017-001267-21 | Ph 1, Ph 2 | terminated | A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) |
| NCT03819465 MAGELLAN | D933IC00001 2018-001748-74 | Ph 1 | active not recruiting | A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC |
| NCT07106762 | CA244-0012 EU CTR, WHO | Ph 2, Ph 3 | recruiting | Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy |
| NCT06230224 OLYMPIA-4 | R1979-HM-2299 2022-502783-21-00 | Ph 3 | active not recruiting | A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma |
| NCT06323239 | SBRT/LDRT+PD-1+GP for r/mNPC | Ph 2 | recruiting | SBRT and LDRT Combined With PD-1 Antibody and Chemotherapy in r/m Nasopharyngeal Carcinoma |
| NCT06929286 | 25-069 | Ph 3 | recruiting | A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC) |
| NCT07566156 | C5701009 EV-309, 2026-525612-34-00 | Ph 3 | recruiting | Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309) |
| NCT06282575 | JZP598-302 2023-508219-21-00 | Ph 3 | recruiting | Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer |
| NCT06919965 MoonRISe-3 | 42756493BLC3005 42756493BLC3005, 2024-519493-39-00 | Ph 3 | recruiting | A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer |
| NCT06632327 | CTIU2317-A082304-S2402 NCI-2024-06356 | Ph 3 | recruiting | Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer |
| NCT06211764 SunRISe-5 | 17000139BLC3004 17000139BLC3004, 2023-507685-10-00 | Ph 3 | active not recruiting | A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG) |
| NCT06319820 MoonRISe-1 | 42756493BLC3004 | Ph 3 | recruiting | A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer |
| NCT05139017 | 2140-003 VLS-101, MK-2140-003 | Ph 2, Ph 3 | recruiting | A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003) |
| NCT06545955 ABLE-22 | 000434 U1111-1299-0176 | Ph 3 | recruiting | A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer |
| NCT04658862 SunRISe-2 | CR108917 17000139BLC3001, 2020-002620-36 | Ph 3 | active not recruiting | A Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder |
| NCT05294172 | KL-A167-III-08 | Ph 3 | active not recruiting | KL-A167 Injection Combined With Cisplatin and Gemcitabine vs Placebo Combined With Cisplatin and Gemcitabine in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma |
| NCT06081959 | SKB264-Ⅲ-10 | Ph 3 | recruiting | Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer |
| NCT07575191 | nEXT-GEM 2025-524733-11-00, 25-10-054715 | Ph 1, Ph 2 | recruiting | Safety and Performance of a Novel Infusion Catheter System for Peri/Intratumoral Gemcitabine Delivery in Patients With Pancreatic Cancer |
| NCT06608927 PRISM-1 | PRISM-1 2024-513317-12-00, jRCT2061240084 | Ph 3 | active not recruiting | Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma |
| NCT06459180 | 2870-020 MK-2870-020, TroFuse-020 | Ph 3 | active not recruiting | A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) |
| NCT06312137 TroFuse-019 | 2870-019 2023-508012-35-00, MK-2870-019 | Ph 3 | recruiting | A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) |
| NCT04104672 ARC-8 | ARC-8 (AB680CSP0002) | Ph 1 | active not recruiting | A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies |
| NCT05601440 | I241 | Ph 2 | recruiting | Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer |
| NCT05524168 | SBRT+PD-1+Chemo for mNPC | Ph 2 | active not recruiting | SBRT Combined With PD-1 Antibody and Chemotherapy in Oligometastatic Nasopharyngeal Carcinoma |
| NCT05171647 SUNMO results posted | GO43643 | Ph 3 | active not recruiting | A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma |
| NCT06023862 DOVE | 4-2023-0794 | Ph 2 | recruiting | A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study) |
| NCT04083599 | GCT1042-01 2018-003716-47, IRAS ID: 263292 | Ph 1, Ph 2 | active not recruiting | GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors |
| NCT07570823 | SCTB35-B301 | Ph 3 | not yet recruiting | A Study to Evaluate the Safety and Efficacy of SCTB35 in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| NCT03652428 | HP-00081403 | Ph 1, Ph 2 | recruiting | Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC) |
| NCT06841354 | 2870-011 MK-2870-011, TroFuse-011 | Ph 3 | recruiting | A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) |
| NCT05104866 results posted | D9268C00001 2023-509631-37-00, 2020-005620-12 | Ph 3 | active not recruiting | A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) |
| NCT05538663 BRIDGE | EA8212 U10CA180820, NCI-2022-04864 | Ph 3 | active not recruiting | Intravesical BCG vs GEMDOCE in NMIBC |
| NCT05548296 | ACR-368-201 (GOG 3082) | Ph 2 | recruiting | A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma |
| NCT04807816 TARSARC | IB 2018-04 2018-003835-31 | Ph 2 | completed | Targeting ATR in Soft-tissue Sarcomas |
| NCT04233866 | EA2186 NCI-2019-08286, EA2186 | Ph 2 | active not recruiting | Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread |
| NCT03456076 results posted | BO40336 2017-004331-37 | Ph 3 | active not recruiting | A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer |
| NCT06623422 | V940-009 2023-506327-29-00, U1111-1293-5814 | Ph 3 | recruiting | A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009) |
Showing 50 of 990 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GEMCITABINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment