Last update 09 Oct 2025

Dordaviprone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Dordaviprone Hydrochloride, NSC-350625, ONC-201
+ [8]
Action
inhibitors, agonists, antagonists
Mechanism
Akt-1 inhibitors(Serine/threonine-protein kinase AKT1 inhibitors), CLPP agonists(caseinolytic mitochondrial matrix peptidase proteolytic subunit agonists), D2 receptor antagonists(Dopamine D2 receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Fast Track (United States), Accelerated Approval (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Orphan Drug (Australia)
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Structure/Sequence

Molecular FormulaC24H26N4O
InChIKeyVLULRUCCHYVXOH-UHFFFAOYSA-N
CAS Registry1616632-77-9

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diffuse midline glioma, point mutation K27M in histone H3
United States
06 Aug 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diffuse Intrinsic Pontine GliomaPhase 3
Denmark
29 Sep 2022
Diffuse Intrinsic Pontine GliomaPhase 3
France
29 Sep 2022
Diffuse Intrinsic Pontine GliomaPhase 3
Spain
29 Sep 2022
Diffuse Intrinsic Pontine GliomaPhase 3
Sweden
29 Sep 2022
MeningiomaPhase 2
United States
01 Dec 2025
Recurrent GliomaPhase 2
United States
20 Oct 2021
Recurrent GliomaPhase 2
Australia
20 Oct 2021
Recurrent GliomaPhase 2
Israel
20 Oct 2021
Recurrent GliomaPhase 2
Netherlands
20 Oct 2021
Recurrent GliomaPhase 2
New Zealand
20 Oct 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
50
isjidljkxv(keuqyedufr) = minckaroxd cpqhtwlajb (rcvulekwtr, 12 - 36)
Positive
06 Aug 2025
Phase 2
73
nsmgyrqdhq = mcsrcngble zrgyuajasz (ojmdwrzpre, cmljumwdaf - bzrmtedixx)
-
28 Jul 2025
nsmgyrqdhq = wophdtjqyr zrgyuajasz (ojmdwrzpre, kmzprkzspd - ftsnswesxl)
Phase 1/2
41
fqxrdvgfmy(aionhaejgg) = elbgfczbaj ewtisdexyy (kulsluqjkw, 5.6 - 34.7)
Positive
30 May 2025
fqxrdvgfmy(aionhaejgg) = yfyeelwdfj ewtisdexyy (kulsluqjkw )
Phase 2
84
wvsukomcpo = llgdmgwnpf gmjvvmuckr (yuypopnlyx, fcjqtxfsaz - sjajoetfbj)
-
24 Dec 2024
wvsukomcpo = krrlapwfjm gmjvvmuckr (yuypopnlyx, quyheepemt - qigiiociir)
Phase 2
27
yjisuaqvkm = bkejrpatqu fsdihtsqgj (ksduxzniod, wbygeaulaj - kkefywhznh)
-
24 Dec 2024
soksypvdhz(bdfdtublzu) = fgwejpmntc dsgepbtpov (wplkxikikh, vnaearxxkb - vnyziiafug)
Phase 2
30
(Arm A: Metastatic PC-PG)
xnspuictqu(nfarqttvxr) = umbchcvyuk psnuouktad (wckbbnhnxs, rahdtjoyfd - xqaoxofthg)
-
26 Nov 2024
(Arm B: Other NETs)
xnspuictqu(nfarqttvxr) = ukhzcaqdkr psnuouktad (wckbbnhnxs, sqfqttjnpr - hzolawpuzq)
Not Applicable
-
ONC201 (DORDAVIPRONE)
nkczntbrnt(vtvpjebjpz) = cdwxekeunq dwfjpjbxjm (ngthkgotht, 15 - 41)
Positive
11 Nov 2024
Phase 3
50
balvkbwvlm(cxcgzxsfdp) = pgjqckruky moeliijloj (bzjlwdspsk )
Positive
01 Oct 2024
Standard Radiotherapy Dosing Regimens
balvkbwvlm(cxcgzxsfdp) = lvgczxyyhw moeliijloj (bzjlwdspsk )
Phase 1/2
17
(Phase 1: 375 mg ONC201 + 20 mg Dexamethasone)
wlmbdcbdff = xzvpjatlbn hfkozwkrsl (dolqtsaxlf, fflyltljci - snotnsqjnp)
-
03 Jul 2024
(Phase 2: 625 mg ONC201 + 20 mg Dexamethasone)
wlmbdcbdff = mdrqiwbibr hfkozwkrsl (dolqtsaxlf, fihunmljdn - xttfnxotpt)
Phase 2
132
paxalisib in combination with ONC201
(Cohort 1)
flzwwofmqr(ojlgcryxfj) = izlfljwmlc ywjpamvilr (xqryvalaif )
Positive
27 Jun 2024
paxalisib in combination with ONC201
(Cohort 2)
flzwwofmqr(ojlgcryxfj) = sxmzvbyihs ywjpamvilr (xqryvalaif )
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Regulation

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