FDA · United States
gemcitabine — FDA regulatory status
gemcitabine (DBL GEMCITABINE INJECTION) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- DBL GEMCITABINE INJECTION
- Originator
- Pfizer Australia Pty Ltd
- Mechanism
- DNA polymerase (alpha/delta/epsilon) inhibitor
- Structured fields
- 7
Sponsor / originator context: Pfizer Australia Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: DNA polymerase (alpha/delta/epsilon) inhibitor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 137 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 000434 | Phase 3 | Ferring Pharmaceuticals | 2024-512177-27-01 |
| 17000139BLC3001 | Phase 3 | Janssen-Cilag International N.V | 2023-507188-21-00 |
| 17000139BLC3004 | Phase 3 | Janssen-Cilag International N.V | 2023-507685-10-00 |
| 2020HXFH037 | Phase 3 | Chinese Academy of | NCT04414566 |
| 42756493BLC3004 | Phase 3 | Janssen-Cilag International N.V | 2023-507684-19-00 |
| 42756493BLC3005 | Phase 3 | Janssen-Cilag International N.V | 2024-519493-39-00 |
| AFMMUChina | Phase 3 | Chinese Academy of | NCT06026878 |
| ALKS 4230-007 | Phase 3 | Createrna Science and | 2024-513230-38-00 |
| BNT327-05 | Phase 3 | BioNTech SE | 2025-521884-12-00 |
| BO42864 | Phase 3 | HOFFMANN-LA ROCHE | 2023-505035-12-00 |
| BT8009-230 | Phase 3 | BICYCLE THERAPEUTICS | 2023-504231-41-01 |
| BT8009-230 | Phase 3 | BICYCLE THERAPEUTICS | 2023-504231-41-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 12377112 | Methods of treating neurocognitive disorders, chronic pain and reducing inflammation | US |
| 12338438 | Conjugated oligonucleotide compounds, methods of making and uses thereof | US |
| 12145943 | Solid forms of 3-(5-Fluorobenzofuran-3-yl)-4-(5-methyl-5H-[1,3]dioxolo[4,5-f]indol-7-yl)pyrrole-2,5-dione | US |
| 12116374 | Solid forms of 3-(5-Fluorobenzofuran-3-yl)-4-(5-methyl-5H-[1,3]dioxolo[4,5-f]indol-7-yl)pyrrole-2,5-dione | US |
| 11970538 | Multispecific binding constructs against checkpoint molecules and uses thereof | US |
| 11865126 | Method for treating anxiety disorders, headache disorders, and eating disorders with psilocybin | US |
| 11738035 | Method for treating anxiety disorders, headache disorders, and eating disorders with psilocybin | US |
| 11661617 | Processes for the production of tryptamines | US |
| 11564935 | Method for treating anxiety disorders, headache disorders, and eating disorders with psilocybin | US |
| 11407759 | Solid forms of 3-(5-fluorobenzofuran-3-yl)-4-(5-methyl-5H-[1,3]dioxolo[4,5-f]indol-7-yl)pyrrole-2,5-dione | US |
| 11136334 | Solid forms of 3-(5-Fluorobenzofuran-3-yl)-4-(5-methyl-5H-[1,3]dioxolo[4,5-f]indol-7-yl)pyrrole-2,5-dione | US |
| 11046769 | Multispecific binding constructs against checkpoint molecules and uses thereof | US |
Related hubs
FAQ
What is the FDA approval status of gemcitabine?
gemcitabine currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get gemcitabine regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to gemcitabine?
This spoke lists 137 published programs associated with gemcitabine in our pipeline index.