Dordaviprone Hydrochloride Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 125 mg

Reference Brands: Modeyso (USA)

Category: Oncology Cancer Care

Dordaviprone (Modeyso) is a novel targeted anticancer medication used to treat diffuse midline glioma with an H3 K27M mutation in adults and children aged 1 year and older. It works by activating mitochondrial protease ClpP and inhibiting dopamine D2 receptors to disrupt tumor growth. This drug is orally administered once weekly as a capsule. It received accelerated FDA approval in 2025 for patients whose disease has progressed after prior therapy. The therapy represents the first systemic option for this rare and aggressive brain tumor.

Product Description:

Dordaviprone is a first‑in‑class small‑molecule anticancer agent marketed under the brand Modeyso in the United States. It is indicated for the treatment of adult and pediatric patients aged 1 year and older with H3 K27M‑mutant diffuse midline glioma, a highly aggressive brain and spinal cord tumor that often progresses despite standard therapies. Dordaviprone’s mechanism involves activating the mitochondrial caseinolytic protease P (ClpP) and inhibiting dopamine D2 receptor (DRD2), leading to mitochondrial stress induction and tumor cell apoptosis, along with epigenetic changes that counter tumor growth. Its once‑weekly oral capsule dosing provides a treatment option delivered outside of hospital settings. The drug received accelerated approval by the U.S. Food and Drug Administration in August 2025, making it the first approved systemic therapy for this rare condition. Clinical data that supported approval were derived from integrated analyses of multiple open‑label studies showing tumor responses in patients with recurrent disease. Side effects may include fatigue, nausea, headache, vomiting, and other treatment‑related adverse events, emphasizing the need for monitoring during therapy. Continued approval may depend on confirmatory trials.