GEMCITABINE HYDROCHLORIDE | N219920 | AVYXA HOLDINGS LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Active | National Cancer Institute (NCI) | 55 | 2009-03-31 → 2027-03-06 | |
| Phase 3 | Active | Merck Sharp & Dohme LLC | 520 | 2020-05-19 → 2031-11-01 | |
| Phase 3 | Active | Sichuan Baili Pharmaceutical Co., Ltd. | 418 | 2024-06-21 → 2027-12 | |
| Phase 2 | Active | Queen Mary University of London | 170 | 2020-04-30 → 2029-02-28 | |
| Phase 1 | Active | AstraZeneca | 175 | 2018-12-27 → 2026-07-01 | |
| Phase 1 | Active | Regeneron Pharmaceuticals | 146 | 2017-06-21 → 2027-09-30 | |
| Phase 2 | Active | St. Jude Children's Research Hospital | 660 | 2013-06-23 → 2031-10-13 | |
| Phase 2/3 | Active | ECOG-ACRIN Cancer Research Group | 186 | 2021-02-24 → 2029-06-30 | |
| Phase 1 | Active | Hoffmann-La Roche | 50 | 2025-04-28 → 2027-03-22 | |
| Phase 3 | Active | Alliance for Clinical Trials in Oncology | 37 | 2024-12-11 → 2030-04-30 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
Lowest Price
$1486.72
Highest Price
$2965.09
FSS NDCs
2
Big4 NDCs
0
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 83831-0123-01AVGEMSI 1GM/26.3ML INJ | $1486.72 | FSS | Avyxa Pharma, LLC | 05/14/2030 |
| 83831-0124-01AVGEMSI 2GM/52.6ML INJ | $2965.09 | FSS | Avyxa Pharma, LLC | 05/14/2030 |
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
16 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| Date | Submission | Document |
|---|---|---|
| Jun 30, 2025 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.