Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Chimerix Announces FDA Acceptance and Priority Review of NDA for Dordaviprone
Details : ONC201 (dordaviprone) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 for recurrent H3 K27M-Mutant diffuse glioma.
Product Name : ONC201
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 18, 2025
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Chimerix Submits Dordaviprone NDA for Accelerated Approval Of Recurrent Diffuse Glioma
Details : ONC201 (dordaviprone) is a novel first-in-class small molecule imipridone that selectively targets the mitochondrial protease ClpP and dopamine receptor D2 for recurrent H3 K27M-Mutant diffuse glioma.
Product Name : Undisclosed
Product Type : Small molecule
Upfront Cash : Not Applicable
December 30, 2024
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Chimerix to Submit Dordaviprone for Accelerated Approval in for H3 K27M-Mutant Glioma
Details : ONC201 (dordaviprone) targets the targets the mitochondrial protease ClpP and dopamine receptor D2. It is being evaluated for the treatment of recurrent H3 K27M-mutant diffuse glioma.
Product Name : Undisclosed
Product Type : Small molecule
Upfront Cash : Not Applicable
December 09, 2024
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ONC201 is a new drug candidate that kills cancer cells but not normal cells in laboratory studies and has been previously evaluated in a phase I clinical trial in advanced cancer patients.
Product Name : ONC201
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
December 08, 2022
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dordaviprone,Paxalisib
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Pacific Pediatric Neuro-Oncology Consortium
Deal Size : Inapplicable
Deal Type : Inapplicable
PNOC Study in Childhood Brain Cancer Enrols First Patient
Details : At the outset, all patients will be treated with ONC201, combined with either paxalisib or panobinostat. The study employs an adaptive design, in which different arms will be opened and closed based on emerging preclinical and clinical data.
Product Name : ONC201
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
November 11, 2021
Lead Product(s) : Dordaviprone,Paxalisib
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Pacific Pediatric Neuro-Oncology Consortium
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Chimerix
Deal Size : $78.0 million
Deal Type : Acquisition
Chimerix Acquires Oncoceutics to Expand Pipeline with Late-Stage Oncology Program
Details : ONC201 is an orally administered small molecule dopamine receptor D2 (DRD2) antagonist and caseinolytic protease (ClpP) agonist in late-stage clinical development for recurrent gliomas that harbor the H3 K27M mutation.
Product Name : ONC201
Product Type : Cytotoxic Drug
Upfront Cash : $39.0 million
January 08, 2021
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Chimerix
Deal Size : $78.0 million
Deal Type : Acquisition
Lead Product(s) : Dordaviprone,Paxalisib
Therapeutic Area : Oncology
Study Phase : Undisclosed
Sponsor : Kazia Therapeutics
Deal Size : Undisclosed
Deal Type : Collaboration
Details : Kazia Therapeutics has executed a Letter of Intent with the Pacific Pediatric Neuro-Oncology Consortium to launch a clinical trial of multiple therapies, including Kazia's investigational, paxalisib, in diffuse midline gliomas including diffuse intrinsic...
Product Name : ONC-201
Product Type : Small molecule
Upfront Cash : Undisclosed
December 10, 2020
Lead Product(s) : Dordaviprone,Paxalisib
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Sponsor : Kazia Therapeutics
Deal Size : Undisclosed
Deal Type : Collaboration
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Grants Rare Pediatric Disease Designation to ONC201 for the Treatment of H3 K27M-Mutant Glioma
Details : Should ONC201 be approved by the FDA for H3 K27M-mutant glioma, the Rare Pediatric Disease Designation may enable Oncoceutics to receive a Rare Pediatric Disease Priority Review Voucher.
Product Name : ONC201
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
July 21, 2020
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The data presented at ASCO 2020 highlights the potential of ONC201 to address the substantial need for patients with H3 K27M-mutant glioma.
Product Name : ONC201
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
May 28, 2020
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase I/II Clinical Study of ONC201 Begins in Japan
Details : Clinical trial provides Japanese patients with high-grade glioma immediate access to ONC201. Data from this study will be an important part of working toward a Japanese market approval for ONC201.
Product Name : ONC201
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
April 01, 2020
Lead Product(s) : Dordaviprone
Therapeutic Area : Oncology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable