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Omacetaxine
Omacetaxine is a Small molecule drug developed by University of Illinois at Chicago. It is currently in Phase 2 development for Chronic myeloid leukemia. Also known as: Synribo, Homoharringtonine, Phase 1, Phase 2.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Omacetaxine |
|---|---|
| Also known as | Synribo, Homoharringtonine, Phase 1, Phase 2, HHT |
| Sponsor | University of Illinois at Chicago |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Approved indications
- Chronic myeloid leukemia
Common side effects
Key clinical trials
- Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia (AML) (PHASE1)
- Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS (PHASE1, PHASE2)
- Omacetaxine and Venetoclax for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Harboring Mutant RUNX1 (PHASE1, PHASE2)
- Study of Azacitidine Combined With Homoharringtonie Based Regimens in AML (PHASE2)
- Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML (PHASE2)
- Homoharringtonine (Omacetaxine Mepesuccinate) in Treating Patients With Chronic Myeloid Leukemia (CML) With the T315I BCR-ABL Gene Mutation (PHASE2)
- A Study to Evaluate the Pharmacokinetics, Safety,and Efficacy of Omacetaxine Given Subcutaneously as a Fixed Dose in Patients With Chronic Phase (CP) or Accelerated Phase (AP) Chronic Myeloid Leukemia (CML) (Referred to as the SYNSINCT Study) (PHASE1, PHASE2)
- AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Omacetaxine CI brief — competitive landscape report
- Omacetaxine updates RSS · CI watch RSS
- University of Illinois at Chicago portfolio CI
Frequently asked questions about Omacetaxine
What is Omacetaxine?
What is Omacetaxine used for?
Who makes Omacetaxine?
Is Omacetaxine also known as anything else?
What development phase is Omacetaxine in?
Related
- Manufacturer: University of Illinois at Chicago — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chronic myeloid leukemia
- Also known as: Synribo, Homoharringtonine, Phase 1, Phase 2, HHT
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing