Dordaviprone — drug · CancerIndex

Regulatory

Approvals (1)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	Diffuse Midline Glioma	MODEYSO is indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). MODEYSO is a protease activator indicated for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. ( 1 ) This indication is approved under accelerated approval based on response rate and duration of response [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).accelerated	approved	Aug 6, 2025	openfda

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	6	6	2	26	1	US	Aug 6, 2025	2014-01
Malignant Central Nervous System Neoplasm	Approved	Phase 3	2	2	1	8	1	US	Aug 6, 2025	2014-01
Malignant Ovarian Neoplasm	Phase2	Phase 2	1	1	0	1	0	—	—	Jan 21, 2020
Malignant Uterine Corpus Neoplasm	Phase2	Phase 2	1	1	0	3

Curated evidence

Clinical evidence (4)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–4 of 4 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
H3-3A K28M2
Dordaviprone	Diffuse Midline Glioma, H3 K27-Altered

Clinical trials

Trials with this intervention (29)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–29 of 29 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT05630794	Testing for Safety and Colorectal Cancer Preventive Effects of ONC201	recruiting	Phase 1	36	National Cancer Institute (NCI)NIH	1	Sep 11, 2026	clinicaltrials
NCT02392572	ONC201 in Treating Patients With Relapsed or Refractory Acute Leukemia or High-Risk Myelodysplastic Syndrome	terminated	Phase 1 / Phase 2