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dordaviprone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5780 | 1616632-77-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Dordaviprone is a small molecule inhibitor of the mitochondrial enzyme caseinolytic protease P (ClpP). Dordaviprone binds to and activates ClpP, resulting in dysregulation of mitochondrial proteostasis and cancer cell death.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 6, 2025 | FDA | CHIMERIX |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| MeSH PA | D000970 | Antineoplastic Agents |
| FDA EPC | N0000194170 | Protease Activator |
| FDA MoA | N0000194171 | Protease Activators |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:68495 | apoptosis inducer |
| CHEBI has role | CHEBI:131787 | dopamine receptor D<small><sub>2</sub></small> antagonist |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Diffuse midline glioma (H3 K27M mutation) | indication | 74532006 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 125MG BASE | MODEYSO | CHIMERIX | N219876 | Aug. 6, 2025 | RX | CAPSULE | ORAL | 9629842 | April 30, 2032 | METHOD OF TREATING 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 |
| EQ 125MG BASE | MODEYSO | CHIMERIX | N219876 | Aug. 6, 2025 | RX | CAPSULE | ORAL | RE46290 | April 30, 2032 | METHOD OF TREATING 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 |
| EQ 125MG BASE | MODEYSO | CHIMERIX | N219876 | Aug. 6, 2025 | RX | CAPSULE | ORAL | 10172862 | Jan. 30, 2037 | METHOD OF TREATING 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 |
| EQ 125MG BASE | MODEYSO | CHIMERIX | N219876 | Aug. 6, 2025 | RX | CAPSULE | ORAL | 10369154 | Jan. 30, 2037 | METHOD OF TREATING 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 |
| EQ 125MG BASE | MODEYSO | CHIMERIX | N219876 | Aug. 6, 2025 | RX | CAPSULE | ORAL | 12102639 | Jan. 30, 2037 | METHOD OF TREATING 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 |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 125MG BASE | MODEYSO | CHIMERIX | N219876 | Aug. 6, 2025 | RX | CAPSULE | ORAL | Aug. 6, 2030 | NEW CHEMICAL ENTITY |
| EQ 125MG BASE | MODEYSO | CHIMERIX | N219876 | Aug. 6, 2025 | RX | CAPSULE | ORAL | Aug. 6, 2032 | 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 |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| ATP-dependent Clp protease proteolytic subunit, mitochondrial | Enzyme | ACTIVATOR | EC50 | 4.90 | DRUG LABEL | DRUG LABEL | |||
| D(2) dopamine receptor | GPCR | ANTAGONIST | Ki | 4.18 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| D(3) dopamine receptor | GPCR | ANTAGONIST | Ki | 4.55 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| CHEMBL4297310 | ChEMBL_ID |
| C585684 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB14844 | DRUGBANK_ID |
| 4044175 | VANDF |
| C5761804 | UMLSCUI |
| CHEBI:232328 | CHEBI |
| CHEMBL6068398 | ChEMBL_ID |
| 12147 | INN_ID |
| D12733 | KEGG_DRUG |
| 1638178-82-1 | SECONDARY_CAS_RN |
| 73777259 | PUBCHEM_CID |
| 397103 | MMSL |
| 44329 | MMSL |
| d10304 | MMSL |
| 020187 | NDDF |
| 020188 | NDDF |
| 9978 | IUPHAR_LIGAND_ID |
| 9U35A31JAI | UNII |
| 2721193 | RXNORM |
| 9U35A31JAI | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| MODEYSO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68727-250 | CAPSULE | 125 mg | ORAL | NDA | 28 sections |