Dordaviprone

Last updated

Dordaviprone
Dordaviprone.svg
Clinical data
Trade names Modeyso
Other namesONC201, ONC-201
AHFS/Drugs.com Modeyso
License data
Routes of
administration 		By mouth
Drug class Protease activator
ATC code
  • None
Legal status
Legal status
Identifiers
  • 11-benzyl-7-[(2-methylphenyl)methyl]-2,5,7,11-tetrazatricyclo[7.4.0.02,6]trideca-1(9),5-dien-8-one
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
Chemical and physical data
Formula C24H26N4O
Molar mass 386.499 g·mol−1
3D model (JSmol)
  • CC1=CC=CC=C1CN2C(=O)C3=C(CCN(C3)CC4=CC=CC=C4)N5C2=NCC5
  • InChI=1S/C24H26N4O/c1-18-7-5-6-10-20(18)16-28-23(29)21-17-26(15-19-8-3-2-4-9-19)13-11-22(21)27-14-12-25-24(27)28/h2-10H,11-17H2,1H3
  • Key:VLULRUCCHYVXOH-UHFFFAOYSA-N
  • Key:HKBXPCQCBQFDML-UHFFFAOYSA-N

Dordaviprone, sold under the brand name Modeyso, is an anti-cancer medication used for the treatment of diffuse midline glioma (a type of brain tumor). [1] [2] Dordaviprone is a protease activator of the mitochondrial caseinolytic protease P. [1] It is dopamine receptor D2 antagonist and an allosteric activator of the mitochondrial caseinolytic protease P. [3]

Contents

Dordaviprone was approved for medical use in the United States in August 2025. [2] It is the first approval of a systemic therapy for H3 K27M-mutant diffuse midline glioma by the US Food and Drug Administration. [2]

Medical uses

Dordaviprone is indicated for the treatment of people with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. [1] [2]

History

Efficacy was evaluated in an integrated efficacy population of 50 participants with recurrent H3 K27M-mutant diffuse midline glioma enrolled across five open-label, non-randomized clinical trials conducted in the US (ONC006 [NCT02525692], ONC013 [NCT03295396], ONC014 [NCT03416530], ONC016 [NCT05392374], and ONC018 [NCT03134131]). [2] The efficacy population comprised participants who received single-agent dordaviprone for diffuse midline glioma harboring an H3 K27M mutation and had progressive and measurable disease per Response Assessment in Neuro-Oncology-High Grade Glioma (RANO-HGG) criteria. [2] Participants were also at least 90 days post radiation therapy, had an adequate washout period from prior anticancer therapies, a Karnofsky Performance Status/Lansky Performance Status (KPS/LPS) score ≥ 60, and stable or decreasing corticosteroid use. [2] Participants with diffuse intrinsic pontine glioma, primary spinal tumors, atypical histologies, or cerebrospinal fluid dissemination were excluded. [2]

The US Food and Drug Administration granted the application for dordaviprone priority review, orphan drug, rare pediatric disease, and fast track designations. [2]

Society and culture

Dordaviprone was approved for medical use in the United States in August 2025. [2] [4]

Names

Dordaviprone is the international nonproprietary name. [5]

Dordaviprone is sold under the brand name Modeyso. [2] [4]

References

  1. 1 2 3 4 https://pp.jazzpharma.com/pi/modeyso.en.USPI.pdf [ bare URL PDF ]
  2. 1 2 3 4 5 6 7 8 9 10 11 "FDA grants accelerated approval to dordaviprone for diffuse midline glioma". U.S. Food and Drug Administration (FDA). 6 August 2025. Retrieved 7 August 2025.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. ↑ Prabhu VV, Morrow S, Rahman Kawakibi A, Zhou L, Ralff M, Ray J, et al. (December 2020). "ONC201 and imipridones: Anti-cancer compounds with clinical efficacy". Neoplasia. 22 (12). New York, N.Y.: 725–744. doi:10.1016/j.neo.2020.09.005. PMC   7588802 . PMID   33142238.
  4. 1 2 "Jazz Pharmaceuticals Announces U.S. FDA Approval of Modeyso (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma" (Press release). Jazz Pharmaceuticals. 6 August 2025. Retrieved 10 August 2025– via PR Newswire.
  5. ↑ World Health Organization (2023). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 89". WHO Drug Information. 37 (1). hdl: 10665/366661 .


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