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elamipretide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| peptides and glycopeptides | 5806 | 736992-21-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Forzinity is a mitochondrial cardiolipin binder that localizes to the inner mitochondrial membrane and improves mitochondrial morphology and function.
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. 19, 2025 | FDA | Stealth BioTherapeutics |
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:
None
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Improvement of muscle strength for Barth syndrome | indication | 297231002 | DOID:0050476 |
🐶 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 280MG BASE/3.5ML (EQ 80MG BASE/ML) | FORZINITY | STEALTH BIOTHERAPS | N215244 | Sept. 19, 2025 | RX | SOLUTION | SUBCUTANEOUS | 11083771 | Feb. 28, 2034 | METHOD FOR TREATING BARTH SYNDROME IN ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 30KG |
| EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) | FORZINITY | STEALTH BIOTHERAPS | N215244 | Sept. 19, 2025 | RX | SOLUTION | SUBCUTANEOUS | 11083772 | Feb. 28, 2034 | METHOD FOR TREATING BARTH SYNDROME IN ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 30KG |
| EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) | FORZINITY | STEALTH BIOTHERAPS | N215244 | Sept. 19, 2025 | RX | SOLUTION | SUBCUTANEOUS | 11771734 | Feb. 28, 2034 | METHOD FOR TREATING BARTH SYNDROME IN ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 30KG |
| EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) | FORZINITY | STEALTH BIOTHERAPS | N215244 | Sept. 19, 2025 | RX | SOLUTION | SUBCUTANEOUS | 12268724 | Feb. 28, 2034 | METHOD FOR TREATING BARTH SYNDROME IN ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 30KG |
| EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) | FORZINITY | STEALTH BIOTHERAPS | N215244 | Sept. 19, 2025 | RX | SOLUTION | SUBCUTANEOUS | 9687519 | Feb. 28, 2034 | METHOD FOR TREATING BARTH SYNDROME IN ADULT AND PEDIATRIC PATIENTS WEIGHING AT LEAST 30KG |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) | FORZINITY | STEALTH BIOTHERAPS | N215244 | Sept. 19, 2025 | RX | SOLUTION | SUBCUTANEOUS | Sept. 19, 2030 | NEW CHEMICAL ENTITY |
| EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML) | FORZINITY | STEALTH BIOTHERAPS | N215244 | Sept. 19, 2025 | RX | SOLUTION | SUBCUTANEOUS | Sept. 19, 2032 | TO IMPROVE MUSCLE STRENGTH IN ADULT AND PEDIATRIC PATIENTS WITH BARTH SYNDROME WEIGHING AT LEAST 30 KG |
Bioactivity Summary:
None
External reference:
| ID | Source |
|---|---|
| CHEMBL3833370 | ChEMBL_ID |
| C506540 | MESH_SUPPLEMENTAL_RECORD_UI |
| DB11981 | DRUGBANK_ID |
| 4044287 | VANDF |
| C4279623 | UMLSCUI |
| CHEMBL4298161 | ChEMBL_ID |
| 10154 | INN_ID |
| 2244098-12-0 | SECONDARY_CAS_RN |
| 11764719 | PUBCHEM_CID |
| 398008 | MMSL |
| 44429 | MMSL |
| d10321 | MMSL |
| 020240 | NDDF |
| 020241 | NDDF |
| 14276 | IUPHAR_LIGAND_ID |
| 87GWG91S09 | UNII |
| 2725599 | RXNORM |
| D10925 | KEGG_DRUG |
| CHEBI:757570 | CHEBI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| FORZINITY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72507-800 | INJECTION | 280 mg | SUBCUTANEOUS | NDA | 28 sections |