Drugs / Dordaviprone
Dordaviprone
also known as
ONC201 · Dordaviprona · Dordaviprone dihydrochloride · DORDAVIPRONE HYDROCHLORIDE · NSC-350625 · ONC-201 DIHYDROCHLORIDE · ONC201 hydrochloride · TIC10 · +1 more
Small molecule targets CLPP, DRD2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | MODEYSO | — | 2025-08-06 | fda.gov ↗ |
Trials 29
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-03-18 | Jazz Pharmaceuticals | Results Jazz Pharmaceuticals to Present Compelling Clinical and Pre-Clinical Data Advancing Oncology Research at AACR 2026 jazzpharma.com ↗
Imipridones ONC201, ONC206, and ONC212 show potent killing and colony arrest of small-cell lung cancer cell lines |
| 2025-08-06 | Jazz Pharmaceuticals | Regulatory Jazz Pharmaceuticals Announces U.S. FDA Approval of Modeyso™ (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma jazzpharma.com ↗
Modeyso is the first and only treatment option approved by the FDA for this ultra-rare and aggressive brain tumor that affects an estimated 2,000 people in the U.S. each year, many of whom are children and young adults. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-18 | Jazz Pharmaceuticals | Jazz Pharmaceuticals to Present Compelling Clinical and Pre-Clinical Data Advancing Oncology Research at AACR 2026 jazzpharma.com ↗ |
| 2025-11-11 | Jazz Pharmaceuticals | Jazz Pharmaceuticals Showcases New Clinical and Translational Data for Modeyso™ (dordaviprone) in H3 K27M-mutant Diffuse Midline Glioma at SNO 2025 jazzpharma.com ↗ |
| 2025-09-09 | Jazz Pharmaceuticals | Modeyso™ (dordaviprone) Included in National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for H3 K27M-mutant Diffuse Glioma jazzpharma.com ↗ |
| 2025-08-20 | Jazz Pharmaceuticals | Jazz Pharmaceuticals to Host Modeyso™ (dordaviprone) Investor Webcast on August 27, 2025 jazzpharma.com ↗ |
| 2025-08-06 | Jazz Pharmaceuticals | Jazz Pharmaceuticals Announces U.S. FDA Approval of Modeyso™ (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma jazzpharma.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dordaviprone | “ONC201 (Dordaviprone) in Recurrent H3 K27M-Mutant Diffuse Midline Glioma.” PMID 38335473 ↗ Feb 20248“ONC201 (dordaviprone) is a ClpP agonist and DRD2 antagonist.” NCT04617002 ↗ “Dordaviprone (ONC201)” NCT05476939 ↗ |
| Known as | Dordaviprona | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297310 ↗ |
| Known as | Dordaviprone dihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297310 ↗ |
| Known as | DORDAVIPRONE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297310 ↗ |
| Known as | NSC-350625 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297310 ↗ |
| Known as | ONC-201 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297310 ↗ |
| Known as | ONC201 | “Dordaviprone (ONC201) is a brain-penetrant, small-molecule imipridone that acts as a mitochondrial caseinolytic protease P (ClpP) agonist and a dopamine receptor D2 (DRD2) antagonist.” NCT02525692 ↗29“This integrated analysis evaluated single-agent ONC201 (dordaviprone), a first-in-class imipridone, in recurrent H3 K27M-mutant DMG.” PMID 38335473 ↗ Feb 2024 “ONC201, now known as dordaviprone” NCT05630794 ↗ “Dordaviprone (ONC201)” NCT03416530 ↗ “Dordaviprone (ONC201)” NCT03485729 ↗ “Dordaviprone (ONC201)” NCT05580562 ↗ |
| Known as | ONC201 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297310 ↗ |
| Known as | TIC10 | “ONC201 (TIC10) is a first-in-class small molecule” NCT02038699 ↗ |
| Known as | TIC10 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297310 ↗ |
| Action | Inhibit | “small molecule antagonist of DRD2” PMID 31118108 ↗ May 2019 |
| Modality | Small molecule | “ONC201 (TIC10) is a first-in-class small molecule” NCT02038699 ↗ |
| Route | Oral | “ONC201 capsules will be administered orally” NCT02038699 ↗ |
| Target | DRD2 | “ONC201 is a small molecule antagonist of DRD2” PMID 31118108 ↗ May 2019 |