Molecular profile
Molecular profile
- Molecule class
- Mitochondrial peptide
- Origin
- Synthetic
- Primary target system
- Cardiolipin-assoziierte mitochondriale Membranprozesse
- Development stage
- Authorised active substance
Aromatisch-kationisches Tetrapeptid mit mitochondrialer Membranaffinität.
Mechanism and signalling
Mechanism and signalling
The peptide is associated with cardiolipin and stabilisation of mitochondrial membrane and electron-transport processes.
Scientific classification
Scientific classification
This profile maps Elamipretide to the research areas mitochondrial, rare_disease. Molecule class, evidence level, development stage and regulatory status are separated so that preclinical findings are not confused with authorised uses.
Mitochondrial peptides, cellular stress, bioenergetics and age-associated pathways.
Peptide therapeutics for molecularly defined rare diseases and specialised treatment concepts.
Evidence base
Approval and post-marketing data
Alongside earlier heterogeneous programmes, an FDA accelerated approval is in place; confirmatory studies remain part of regulatory obligations.
Regulatory status
Specifically approved in the U.S.
The substance has a specific U.S. approval. This does not constitute general authorisation in Germany or the European Union, nor approval of unlicensed products.
Safety and use notice
No dosing or administration recommendation
The available evidence does not establish safe self-directed use. This profile intentionally provides no dosing, sourcing or administration guidance.
Sources and registries