MTP-131 ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
21Mitochondrial disease3

21. Mitochondrial disease


Clinical trials : 33 Drugs : 42 - (DrugBank : 32) / Drug target genes : 47 - Drug target pathways : 67
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PhaseCountries
1EUCTR2021-003907-16-HU
(EUCTR)
02/03/202204/01/2022Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)A Phase 3 Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Subjects with Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD) Primary Mitochondrial Disease Resulting from Pathogenic Nuclear DNA Mutations (nPMD)
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: HLGT;Classification code 10052635;Term: Cytoplasmic disorders congenital;Level: HLT;Classification code 10052637;Term: Genetic mitochondrial abnormalities NEC;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Elamipretide
Product Code: MTP-131
INN or Proposed INN: ELAMIPRETIDE
Other descriptive name: N/A
Stealth BioTherapeutics Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Hungary;Finland;Spain;Denmark;Australia;Norway;Netherlands;Germany;United Kingdom;Italy
2NCT02805790
(ClinicalTrials.gov)
August 22, 201613/6/2016Safety, Tolerability, Efficacy of MTP-131 for Treatment of Mitochondrial Disease in Subjects From the MMPOWER StudyA Phase 2 Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate Safety, Tolerability, and Efficacy of Subcutaneous Injections of MTP-131 in Subjects With Mitochondrial Myopathy Previously Treated in the SPIMM-201 StudyPrimary Mitochondrial DiseaseDrug: Elamipretide;Drug: PlaceboStealth BioTherapeutics Inc.NULLCompleted16 YearsN/AAll30Phase 2United States
3NCT02367014
(ClinicalTrials.gov)
February 20159/2/2015Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial MyopathyPhase 1/2 Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending-Dose Clinical Study for the Safety, Tolerability, and Efficacy of IV MTP-131 for Mitochondrial Myopathy in Genetically Confirmed Mitochondrial DiseaseMitochondrial MyopathyDrug: elamipretide (low dose);Drug: elamipretide (intermediate dose);Drug: elamipretide (high dose);Drug: PlaceboStealth BioTherapeutics Inc.NULLCompleted16 Years65 YearsAll36Phase 1/Phase 2United States