Birabresib — drug · CancerIndex

Regulatory

Approvals (0)

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

Data not yet available

No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.

What CancerIndex knows

Curated evidence below
Sources

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	Trials	Jurisdictions	First approval	First trial
All cancers	Phase2	Phase 2	5	—	—	Oct 23, 2014
Leukemia	Phase2	Phase 2	1	—	—	2015-01
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	1	—	—	Oct 29, 2014
Malignant Breast Neoplasm	Phase1	Phase 1	2	—

Curated evidence

Clinical evidence (3)

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

civicCuratedShowing 1–3 of 3 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
TCF19 EXPRESSION1
Birabresib + Mirdametinib

Clinical trials

Trials with this intervention (5)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–5 of 5 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
NCT02698189	A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005)	terminated	Phase 1	9	Merck Sharp & Dohme LLCINDUSTRY	0	Sep 13, 2022	clinicaltrials
NCT02698176	A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Advanced Solid Tumors (MK-8628-006)	terminated