Elamipretide
Elamipretide is a protein pharmaceutical. It is currently being investigated in clinical studies.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Elamipretide hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FORZINITY | STEALTH BIOTHERAPS | N-215244 RX | 2025-09-19 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| forzinity | New Drug Application | 2025-12-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| barth syndrome | Orphanet_111 | D056889 | E78.71 |
Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
31 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mitochondrial diseases | D028361 | EFO_0000591 | — | 1 | 3 | 1 | — | 1 | 5 |
| Mitochondrial myopathies | D017240 | Orphanet_206966 | G71.3 | 1 | 3 | 2 | — | — | 5 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 2 | 2 | 1 | — | — | 4 |
| Barth syndrome | D056889 | Orphanet_111 | E78.71 | — | 1 | 1 | — | 1 | 2 |
| Muscular diseases | D009135 | EFO_0002970 | G72.9 | 1 | 1 | 1 | — | — | 2 |
| Syndrome | D013577 | — | — | — | 1 | 1 | — | — | 1 |
| Muscle weakness | D018908 | — | — | — | — | 1 | — | — | 1 |
| Cytochrome-c oxidase deficiency | D030401 | — | — | — | — | 1 | — | — | 1 |
| Chronic progressive external ophthalmoplegia | D017246 | — | H49.4 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 2 | 3 | — | — | — | 5 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 2 | — | — | — | 2 |
| Reperfusion injury | D015427 | — | — | 1 | 2 | — | — | — | 2 |
| Geographic atrophy | D057092 | — | — | — | 1 | — | — | — | 1 |
| Optic nerve diseases | D009901 | EFO_1001330 | H47.14 | — | 1 | — | — | — | 1 |
| Hereditary optic atrophy leber | D029242 | Orphanet_104 | H47.22 | — | 1 | — | — | — | 1 |
| Fuchs' endothelial dystrophy | D005642 | EFO_0003946 | H18.51 | 1 | 1 | — | — | — | 1 |
| Hereditary corneal dystrophies | D003317 | — | H18.5 | 1 | 1 | — | — | — | 1 |
| Macular edema | D008269 | — | — | 1 | 1 | — | — | — | 1 |
| Edema | D004487 | — | R60.9 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Renal insufficiency | D051437 | — | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Elamipretide |
| INN | elamipretide |
| Description | Elamipretide (also known as SS-31, , MTP-131 and Bendavia) is a small mitochondrially-targeted tetrapeptide (D-Arg-dimethylTyr-Lys-Phe-NH2) that appears to reduce the production of toxic reactive oxygen species and stabilize cardiolipin.
|
| Classification | Protein |
| Drug class | peptides |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1cc(O)cc(C)c1C[C@H](NC(=O)[C@H](N)CCCNC(=N)N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1ccccc1)C(N)=O |
Identifiers
| PDB | — |
| CAS-ID | 736992-21-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3833370 |
| ChEBI ID | — |
| PubChem CID | 11764719 |
| DrugBank | DB11981 |
| UNII ID | 87GWG91S09 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
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