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Aclacur (ACLARUBICIN)
Aclacur (generic name: ACLARUBICIN) is a aclarubicin drug. It is currently in Phase 3 development for Acute myeloid leukemia, disease.
Aclacur works by binding to the 5-hydroxytryptamine receptor 2B, which is involved in cell growth and proliferation.
Aclacur, also known as aclarubicin, is a small molecule drug that targets the 5-hydroxytryptamine receptor 2B. It is used to treat acute myeloid leukemia. The commercial status of Aclacur is unknown, and it is not clear if it is patented or available as a generic. Aclacur's safety considerations are also unknown. Further research is needed to fully understand its pharmacological properties.
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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 | ACLARUBICIN |
|---|---|
| Drug class | aclarubicin |
| Target | 5-hydroxytryptamine receptor 2B |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Imagine your cells are like a city, and the 5-hydroxytryptamine receptor 2B is like a traffic light that helps control how fast the city grows. Aclacur is like a traffic cop that blocks the traffic light, slowing down the growth of cancer cells. This helps to stop the cancer from spreading.
Approved indications
- Acute myeloid leukemia, disease
Common side effects
- Bone marrow failure
- Myelosuppression
Key clinical trials
- Aclarubicin Plus With Azacitidine and Venetoclax in the Treatment of Acute Myeloid Leukemia (PHASE1,PHASE2)
- A Multicenter RCT of "3+7" vs Venetoclax + CACAG in Newly Diagnosed Mid/High-Risk AML Patients (PHASE2)
- Pre-DLI or Pro-DLI in Relapsed/Refractory Myeloid Neoplasms After HSCT (NA)
- A Clinical Study of VA-CAG as Induction Therapy in Newly Diagnosed AML Patients (PHASE2)
- Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients (PHASE2)
- A Study on the Efficacy and Safety of Venetoclax Combined With HAA Regimen in Newly Diagnosed Young AML. (PHASE1,PHASE2)
- Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML (PHASE3)
- Dual Growth Factor (rhTPO + G-CSF) and Chemotherapy Combination Regimen in Acute Myeloid Leukemia: Study Protocol for a Randomized Controlled Trial (PHASE3)
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:
- Aclacur CI brief — competitive landscape report
- Aclacur updates RSS · CI watch RSS
Frequently asked questions about Aclacur
What is Aclacur?
How does Aclacur work?
What is Aclacur used for?
What is the generic name of Aclacur?
What drug class is Aclacur in?
What development phase is Aclacur in?
What are the side effects of Aclacur?
What does Aclacur target?
Related
- Drug class: All aclarubicin drugs
- Target: All drugs targeting 5-hydroxytryptamine receptor 2B
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute myeloid leukemia, disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing