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aclacinomycin
aclacinomycin is a Small molecule drug developed by Chinese PLA General Hospital. It is currently in Phase 3 development for Acute myeloid leukemia, disease. Also known as: ACM.
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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.
| 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 name | aclacinomycin |
|---|---|
| Also known as | ACM |
| Sponsor | Chinese PLA General Hospital |
| Target | 72 kDa type IV collagenase, DNA topoisomerase II, 5-hydroxytryptamine receptor 2B |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Approved indications
- Acute myeloid leukemia, disease
Common side effects
Key clinical trials
- A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients (PHASE2)
- Venetoclax Plus CACAG Regimen for Newly Diagnosed Acute Myeloid Leukemia (PHASE2)
- A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients (PHASE2)
- Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia (PHASE3)
- MRD Response-adapted Allo-HSCT for Adverse-risk AML (NA)
- Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia (PHASE2)
- Selinexor and HAAG With/Without HMA in Relapsed/Refractory Acute Leukemia (AML) Patients (NA)
- Venetoclax Combined With Azacitidine and CAG in Refractory/Relapse Acute Myeloid Leukemia (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:
- aclacinomycin CI brief — competitive landscape report
- aclacinomycin updates RSS · CI watch RSS
- Chinese PLA General Hospital portfolio CI
Frequently asked questions about aclacinomycin
What is aclacinomycin?
What is aclacinomycin used for?
Who makes aclacinomycin?
Is aclacinomycin also known as anything else?
What development phase is aclacinomycin in?
What does aclacinomycin target?
Related
- Target: All drugs targeting 72 kDa type IV collagenase, DNA topoisomerase II, 5-hydroxytryptamine receptor 2B
- Manufacturer: Chinese PLA General Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute myeloid leukemia, disease
- Also known as: ACM
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing