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arimoclomol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5857 | 289893-25-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Arimoclomol is an orally active small molecule that acts as a co-inducer of heat shock proteins (HSPs). It enhances the cellular stress response by amplifying the production of molecular chaperones, promoting proper protein folding and reducing the accumulation of misfolded proteins. Arimoclomol has been developed for the treatment of diseases associated with protein misfolding and lysosomal dysfunction, including Niemann–Pick disease type C and other neurodegenerative disorders.
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 |
|---|---|---|---|
| Sept. 20, 2024 | FDA | Zevra Therapeutics Inc. |
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 |
|---|---|---|
| ATC | N07XX17 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
| FDA MoA | N0000187061 | Organic Cation Transporter 2 Inhibitors |
Related Drugs by ATC class:
N07XX Other nervous system drugs 23 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Niemann-Pick disease, type C | indication | 66751000 |
🐶 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 124MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 9884058 | June 26, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 47MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 9884058 | June 26, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 62MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 9884058 | June 26, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 93MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 9884058 | June 26, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 124MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 9289472 | Aug. 11, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 47MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 9289472 | Aug. 11, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 62MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 9289472 | Aug. 11, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 93MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 9289472 | Aug. 11, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 124MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 11045460 | Aug. 19, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 47MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 11045460 | Aug. 19, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 62MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 11045460 | Aug. 19, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 93MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 11045460 | Aug. 19, 2029 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 124MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 11707456 | Nov. 19, 2041 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 47MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 11707456 | Nov. 19, 2041 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 62MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 11707456 | Nov. 19, 2041 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
| EQ 93MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | 11707456 | Nov. 19, 2041 | USE OF ARIMOCLOMOL, IN COMBINATION WITH MIGLUSTAT, FOR TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 124MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | Sept. 20, 2029 | NEW CHEMICAL ENTITY |
| EQ 47MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | Sept. 20, 2029 | NEW CHEMICAL ENTITY |
| EQ 62MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | Sept. 20, 2029 | NEW CHEMICAL ENTITY |
| EQ 93MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | Sept. 20, 2029 | NEW CHEMICAL ENTITY |
| EQ 124MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | Sept. 20, 2031 | TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
| EQ 47MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | Sept. 20, 2031 | TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
| EQ 62MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | Sept. 20, 2031 | TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
| EQ 93MG BASE | MIPLYFFA | ZEVRA DENMARK | N214927 | Sept. 20, 2024 | RX | CAPSULE | ORAL | Sept. 20, 2031 | TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| CHEMBL2107726 | ChEMBL_ID |
| C486387 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB05025 | DRUGBANK_ID |
| 4043424 | VANDF |
| C1451975 | UMLSCUI |
| CHEBI:747211 | CHEBI |
| CHEMBL4298149 | ChEMBL_ID |
| 8300 | INN_ID |
| 368860-21-3 | SECONDARY_CAS_RN |
| 208924 | PUBCHEM_CID |
| 8271 | IUPHAR_LIGAND_ID |
| EUT3557RT5 | UNII |
| 2694282 | RXNORM |
| D11374 | KEGG_DRUG |
| 389265 | MMSL |
| 43154 | MMSL |
| d10220 | MMSL |
| 019855 | NDDF |
| 019856 | NDDF |
| EUT3557RT5 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| MIPLYFFA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72542-124 | CAPSULE | 124 mg | ORAL | NDA | 28 sections |
| MIPLYFFA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72542-147 | CAPSULE | 47 mg | ORAL | NDA | 28 sections |
| MIPLYFFA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72542-162 | CAPSULE | 62 mg | ORAL | NDA | 28 sections |
| MIPLYFFA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72542-193 | CAPSULE | 93 mg | ORAL | NDA | 28 sections |