Tovorafenib is a synthetic small-molecule type II RAF kinase inhibitor developed for the treatment of BRAF-altered tumors. It is marketed as OJEMDA and is used for patients with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion/rearrangement or BRAF V600 mutation. The FDA identifies tovorafenib as a kinase inhibitor and provides its molecular formula as C₁₇H₁₂Cl₂F₃N₇O₂S with a molecular weight of 506.29 g/mol.
Tovorafenib is a selective pan-RAF inhibitor that targets RAF signaling within the MAPK pathway. Its chemical structure contains chlorinated pyrimidine and pyridine groups, a trifluoromethyl substituent and a thiazole carboxamide framework. PubChem identifies the API under CAS 1096708-71-2 and FDA GSRS lists UNII ZN90E4027M.
Tovorafenib is a chiral, orally active antineoplastic small molecule. It inhibits RAF kinase signaling, including mutant BRAF and wild-type BRAF/CRAF activity, thereby interfering with the RAS-RAF-MEK-ERK signaling pathway involved in tumor-cell proliferation.
The FDA describes tovorafenib as a white to off-white powder. Its aqueous solubility is very low, with solubility at 37°C reported as ≤3 µg/mL from pH 1.2 to 8.
| Property | Details |
|---|---|
| Product Name | Tovorafenib |
| API Type | Synthetic small-molecule API |
| CAS Number | 1096708-71-2 |
| UNII | ZN90E4027M |
| Molecular Formula | C₁₇H₁₂Cl₂F₃N₇O₂S |
| Molecular Weight | 506.29 g/mol |
| IUPAC Name | 2-[(1R)-1-[(6-amino-5-chloropyrimidine-4-carbonyl)amino]ethyl]-N-[5-chloro-4-(trifluoromethyl)pyridin-2-yl]-1,3-thiazole-5-carboxamide |
| Therapeutic Class | Antineoplastic agent |
| Pharmacological Class | Type II RAF kinase inhibitor |
| ATC Code | L01EC04 |
| Development Names | DAY101, TAK-580, MLN2480, BIIB-024 |
| Brand | OJEMDA |
| Appearance | White to off-white powder |
| Solubility | ≤3 µg/mL in aqueous media at 37°C, pH 1.2–8 |
The identity, formula, molecular weight and CAS number are supported by FDA GSRS/PubChem, while the FDA prescribing information confirms the physical description and aqueous solubility.
Tovorafenib is an orally administered targeted anticancer API. The FDA approved OJEMDA for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
Tovorafenib acts as a type II RAF kinase inhibitor, targeting RAF proteins involved in the MAPK signaling pathway. It has activity against mutant BRAF V600E as well as wild-type BRAF and CRAF.
Swapnroop Drugs & Pharmaceuticals provides API sourcing and supply support for Tovorafenib for pharmaceutical development and manufacturing requirements. The company focuses on specification-based API supply, documentation, appropriate packaging and batch-level quality requirements.
For pharmaceutical manufacturers, formulation developers and qualified procurement organizations seeking Tovorafenib API in India, Swapnroop can support bulk requirements according to agreed technical specifications and commercial requirements.
Tovorafenib API should be packaged in suitable pharmaceutical-grade, tightly closed containers that protect the material from moisture and environmental contamination. Storage conditions should follow the applicable approved product specification and stability data.
Packaging quantities can be customized according to customer requirements, batch size and intended application.
Documentation may include:
Swapnroop Drugs & Pharmaceuticals supports pharmaceutical companies seeking reliable Tovorafenib API manufacturer and supplier services in India. The supply approach emphasizes product identity, specification-based quality evaluation, traceability, suitable packaging and technical documentation.
For bulk Tovorafenib API requirements, customers can contact Swapnroop for product availability, specifications, documentation and commercial quotations.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |