Drugs / Omacetaxine
Omacetaxine
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04926285 | Jun 2022 → Jan 2024 | refractory hematologic cancer | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 1 | NCT02141477 | May 2015 → Jun 2017 | leukemia | M.D. Anderson Cancer Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00675350 | Apr → Sep 2008 | hematopoietic and lymphoid cell neoplasm | ChemGenex Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03564873 | Sep 2018 → Oct 2025 overdue | myelodysplastic syndrome | University of Colorado, Denver | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02835794 | Aug 2016 → Dec 2018 | myelodysplastic syndrome | University of Florida | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02440568 | Jun 2015 → Nov 2018 | acute myeloid leukemia | University of Illinois at Chicago | Terminated | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT02159872 | May 2015 → Apr 2020 | leukemia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01873495 | May 2013 → Jul 2018 | acute myeloid leukemia | Emory University | Terminated | No outcome recorded |
| Phase 2 | NCT01272245 | Jul 2011 → Jan 2017 | leukemia | M.D. Anderson Cancer Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2014-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory FDA Approves Teva’s SYNRIBO® (Omacetaxine Mepesuccinate) for Injection for Home Administration tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved SYNRIBO® (omacetaxine mepesuccinate) for injection, for subcutaneous use, to include home administration, and also approved a related Medication Guide and Instructions for Use. |
| 2014-02-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Full FDA Approval of SYNRIBO® (Omacetaxine Mepesuccinate) for Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval of SYNRIBO® (omacetaxine mepesuccinate) for injection. |
| 2012-10-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Approval For SYNRIBOTM (Omacetaxine Mepesuccinate) for Injection tevapharm.com ↗
SYNRIBO received an accelerated approval |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | FDA Approves Teva’s SYNRIBO® (Omacetaxine Mepesuccinate) for Injection for Home Administration tevapharm.com ↗ |
| 2014-02-13 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Full FDA Approval of SYNRIBO® (Omacetaxine Mepesuccinate) for Injection tevapharm.com ↗ |
| 2012-10-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives Approval For SYNRIBOTM (Omacetaxine Mepesuccinate) for Injection tevapharm.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Omacetaxine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02159872 ↗ |
| Known as | oma | “We designed a phase 1/2 clinical trial to examine the safety/efficacy of the protein synthesis inhibitor omacetaxine mepesuccinate (oma) with the hypomethylating agent (HMA)...” PMID 41140451 ↗ Oct 2025 |
| Known as | omacetaxine mepesuccinate | “We designed a phase 1/2 clinical trial to examine the safety/efficacy of the protein synthesis inhibitor omacetaxine mepesuccinate (oma) with the hypomethylating agent (HMA)...” PMID 41140451 ↗ Oct 2025 |
| Action | Inhibit | “Omacetaxine is designed to block certain proteins, which may cause cancer cells to die.” NCT01272245 ↗ |
| Route | Subcutaneous | “1.25 mg/m2 subcutaneous twice daily for 14 days” NCT00675350 ↗ |