Last reviewed · How we verify

Homoharringtonine

ChemGenex Pharmaceuticals · Phase 3 active Small molecule Quality 13/100

Homoharringtonine is a Small molecule drug developed by ChemGenex Pharmaceuticals. It is currently in Phase 3 development for Chronic myeloid leukemia. Also known as: Omacetaxine mepesuccinate, CGX-635, HHT, Omacetaxine mepesuccinate, HHT.

Likelihood of approval
61.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
  • Oncology Phase 3 boost +3.0pp
    Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Predicted approval windows by jurisdiction (conditional on FDA approval)
Regulator Country Likely year Lag vs FDA
FDA US 2028–2030 —
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameHomoharringtonine
Also known asOmacetaxine mepesuccinate, CGX-635, HHT, Omacetaxine mepesuccinate, HHT, Dexamethasone
SponsorChemGenex Pharmaceuticals
ModalitySmall molecule
Therapeutic areaOncology
PhasePhase 3

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Homoharringtonine

What is Homoharringtonine?

Homoharringtonine is a Small molecule drug developed by ChemGenex Pharmaceuticals, indicated for Chronic myeloid leukemia.

What is Homoharringtonine used for?

Homoharringtonine is indicated for Chronic myeloid leukemia.

Who makes Homoharringtonine?

Homoharringtonine is developed by ChemGenex Pharmaceuticals (see full ChemGenex Pharmaceuticals pipeline at /company/chemgenex-pharmaceuticals).

Is Homoharringtonine also known as anything else?

Homoharringtonine is also known as Omacetaxine mepesuccinate, CGX-635, HHT, Omacetaxine mepesuccinate, HHT, Dexamethasone.

What development phase is Homoharringtonine in?

Homoharringtonine is in Phase 3.

What are the side effects of Homoharringtonine?

Common side effects of Homoharringtonine include Febrile neutropenia, General disorders and administration site conditions - Other, specify, Abdominal Pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Creatinine increased.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing