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Vesanoid
Vesanoid is a Small molecule drug developed by Centre Leon Berard. It is currently in Phase 3 development. Also known as: ATRA, Tretinoin.
Vesanoid, also known as all-trans retinoic acid (ATRA), is a medication that acts as a retinoic acid receptor agonist. It is used to treat Acute Myelogenous Leukaemia (AML) and Myelodysplastic Syndrome (MDS), particularly in cases with the RARA-PML fusion mutation.
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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).
| 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 | Vesanoid |
|---|---|
| Also known as | ATRA, Tretinoin |
| Sponsor | Centre Leon Berard |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma (PHASE1)
- Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906) (PHASE1, PHASE2)
- A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris (PHASE1)
- Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (PHASE3)
- Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (PHASE3)
- All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma (PHASE2)
- Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia (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:
- Vesanoid CI brief — competitive landscape report
- Vesanoid updates RSS · CI watch RSS
- Centre Leon Berard portfolio CI
Frequently asked questions about Vesanoid
What is Vesanoid?
Who makes Vesanoid?
Is Vesanoid also known as anything else?
What development phase is Vesanoid in?
Related
- Manufacturer: Centre Leon Berard — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: ATRA, Tretinoin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing