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Elamipretide Acetate

Alias: SS31; MTP 131 acetate; SS-31; MTP131 acetate; Elamipretide Acetate; 1334953-95-5; MTP 131 acetate; acetic acid;(2S)-6-amino-2-[[(2S)-2-[[(2R)-2-amino-5-(diaminomethylideneamino)pentanoyl]amino]-3-(4-hydroxy-2,6-dimethylphenyl)propanoyl]amino]-N-[(2S)-1-amino-1-oxo-3-phenylpropan-2-yl]hexanamide; MTP 131 (acetate);SS 31; MTP-131 acetate
Cat No.:V2304 Purity: ≥98%
Elamipretide Acetate(also known asMTP-131Acetate; SS-31) is an efficacious antioxidant that is amitochondria-targeting peptide andhas the capacity to reduce mitochondrial ROS and scavenge free radicals.
Elamipretide Acetate
Elamipretide Acetate Chemical Structure CAS No.: 1334953-95-5
Product category: Others 6
This product is for research use only, not for human use. We do not sell to patients.
Size Price Stock Qty
5mg
10mg
25mg
50mg
100mg
Other Sizes

Other Forms of Elamipretide Acetate:

  • Elamipretide
  • Elamipretide TFA
Official Supplier of:
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Purity & Quality Control Documentation

Purity: =99.62%

Product Description

Elamipretide Acetate(also known as MTP-131 Acetate; SS-31) is an efficacious antioxidant that is a mitochondria-targeting peptide and has the capacity to reduce mitochondrial ROS and scavenge free radicals.

On September 19, 2025, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria (the energy-producing parts of cells). “The FDA remains committed to facilitating the development of effective and safe therapies for rare diseases and will continue to work diligently to help ensure patients with rare diseases have access to innovative treatments," said George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research.
Biological Activity I Assay Protocols (From Reference)
Targets
Mitochondrial cardiolipin
ln Vitro
Barth syndrome is a rare X-linked genetic disorder characterized by mitochondrial dysfunction. Elamipretide is a mitochondrial cardiolipin binder that penetrates cells and accumulates in the mitochondria: It localizes to the inner mitochondrial membrane, improving mitochondrial morphology and function. Elamipretide's mechanism of action involves electrostatic interactions with cardiolipin, a phospholipid critical for mitochondrial structure and electron transport chain function. By binding to cardiolipin, elamipretide stabilizes the mitochondrial membrane, prevents oxidative damage, and maintains membrane potential. This interaction preserves cristae integrity, reduces reactive oxygen species (ROS) production, and maintains ATP production. Elamipretide also enhances the activity of mitochondrial respiratory complexes, facilitating efficient electron transfer and ATP synthesis. Furthermore, elamipretide inhibits the opening of the mitochondrial permeability transition pore (mPTP), protecting against mitochondrial damage during reperfusion and reducing cell death in ischemic conditions.
ln Vivo
Elamipretide is a mitochondrial cardiolipin binder that localizes to the inner mitochondrial membrane to improve mitochondrial morphology and function. Elamipretide was shown to attenuate neuronal oxidative stress and neuroinflammation, activate neural mitochondrial biogenesis, enhance mitochondrial respiration, and protect against neural apoptosis. Protective effects of elamipretide against neuronal loss and inflammation have been reported in traumatic brain injury, hind limb ischemia–reperfusion injury, type II diabetes, and spinal cord injury. Clinically significant QTc interval prolongation was not observed at three times the peak concentration of the maximum recommended dose.
Elamipretide is a mitochondrial cardiolipin binder being investigated for diseases involving mitochondrial dysfunction. Elamipretide is a synthetic tetrapeptide that selectively binds to cardiolipin, a phospholipid in the inner mitochondrial membrane. This interaction improves mitochondrial morphology and function. In September 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval for FORZINITY™ (elamipretide) to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. ELAMIPRETIDE is a Protein drug with a maximum clinical trial phase of III (across all indications) and has 10 investigational indications.
ADME/Pharmacokinetics
Absorption
After daily subcutaneous injection of 2 to 80 mg, ilapipritide exposure increases proportionally with increasing dose, with minimal accumulation. Maximum ilapipritide concentrations are reached 0.5 to 1 hour after subcutaneous injection. The absolute bioavailability after subcutaneous injection is approximately 92%. Exposure is comparable after subcutaneous injection into the thigh or abdomen.
Elimination Route
Ilamipretide and its metabolites M1 and M2 are excreted in the urine. In patients with normal renal function, approximately 100% of the ilapipritide dose is recovered in the urine 48 hours after administration, present as ilapipritide, M1, or M2.
Volume of Distribution
Ilamipretide is distributed in systemic water, with a volume of distribution of approximately 0.5 L/kg.
Protein Binding
Protein binding is approximately 39%.
Metabolism/Metabolites
Elamipretide is metabolized via C-terminal degradation into M1 tripeptide and M2 dipeptide metabolites, which are not pharmacologically active. Its metabolic pathway is not fully elucidated.
References
[1]. https://pubchem.ncbi.nlm.nih.gov/compound/11764719
Additional Infomation
Elamipretide is a mitochondrial cardiolipin binder currently under investigation for its efficacy in treating diseases related to mitochondrial dysfunction. Ilamipreptide is a synthetic tetrapeptide that selectively binds to cardiolipin, a phospholipid on the inner mitochondrial membrane. This interaction can improve mitochondrial morphology and function. In September 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to FORZINITY™ (imlamipreptide) for improving muscle strength in adults and children with Barth syndrome weighing at least 30 kg. Ilamipreptide is a protein-based drug that has completed up to three Phase III clinical trials (covering all indications) and has 10 investigational indications.
These protocols are for reference only. InvivoChem does not independently validate these methods.
Physicochemical Properties
Molecular Formula
C34H53N9O7
Molecular Weight
699.84
Exact Mass
699.406
CAS #
1334953-95-5
Related CAS #
736992-21-5;1334953-95-5 (acetate);2244098-12-0 (HCl); 1606994-55-1
PubChem CID
163336973
Sequence
H-D-Arg-Tyr(2,6-diMe)-Lys-Phe-NH2.CH3CO2H; D-arginyl-2,6-dimethyl-L-tyrosyl-L-lysyl-L-phenylalaninamide acetic acid
SequenceShortening
RXKF
Appearance
Solid powder
Hydrogen Bond Donor Count
10
Hydrogen Bond Acceptor Count
10
Rotatable Bond Count
19
Heavy Atom Count
50
Complexity
1020
Defined Atom Stereocenter Count
4
SMILES
CC1=CC(=CC(=C1C[C@@H](C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC2=CC=CC=C2)C(=O)N)NC(=O)[C@@H](CCCN=C(N)N)N)C)O.CC(=O)O
InChi Key
UEYRJRBULBAAEG-NFWUDPOKSA-N
InChi Code
InChI=1S/C32H49N9O5.C2H4O2/c1-19-15-22(42)16-20(2)23(19)18-27(41-29(44)24(34)11-8-14-38-32(36)37)31(46)39-25(12-6-7-13-33)30(45)40-26(28(35)43)17-21-9-4-3-5-10-21;1-2(3)4/h3-5,9-10,15-16,24-27,42H,6-8,11-14,17-18,33-34H2,1-2H3,(H2,35,43)(H,39,46)(H,40,45)(H,41,44)(H4,36,37,38);1H3,(H,3,4)/t24-,25+,26+,27+;/m1./s1
Chemical Name
(S)-6-amino-N-((S)-1-amino-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-((R)-2-amino-5-guanidinopentanamido)-3-(4-hydroxy-2,6-dimethylphenyl)propanamido)hexanamide acetate
Synonyms
SS31; MTP 131 acetate; SS-31; MTP131 acetate; Elamipretide Acetate; 1334953-95-5; MTP 131 acetate; acetic acid;(2S)-6-amino-2-[[(2S)-2-[[(2R)-2-amino-5-(diaminomethylideneamino)pentanoyl]amino]-3-(4-hydroxy-2,6-dimethylphenyl)propanoyl]amino]-N-[(2S)-1-amino-1-oxo-3-phenylpropan-2-yl]hexanamide; MTP 131 (acetate);SS 31; MTP-131 acetate
HS Tariff Code
2934.99.9001
Storage

Powder      -20°C    3 years

                     4°C     2 years

In solvent   -80°C    6 months

                  -20°C    1 month

Shipping Condition
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
Solubility Data
Solubility (In Vitro)
May dissolve in DMSO (in most cases), if not, try other solvents such as H2O, Ethanol, or DMF with a minute amount of products to avoid loss of samples
Solubility (In Vivo)
Note: Listed below are some common formulations that may be used to formulate products with low water solubility (e.g. < 1 mg/mL), you may test these formulations using a minute amount of products to avoid loss of samples.

Injection Formulations
(e.g. IP/IV/IM/SC)
Injection Formulation 1: DMSO : Tween 80: Saline = 10 : 5 : 85 (i.e. 100 μL DMSO stock solution 50 μL Tween 80 850 μL Saline)
*Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH ₂ O to obtain a clear solution.
Injection Formulation 2: DMSO : PEG300Tween 80 : Saline = 10 : 40 : 5 : 45 (i.e. 100 μL DMSO 400 μLPEG300 50 μL Tween 80 450 μL Saline)
Injection Formulation 3: DMSO : Corn oil = 10 : 90 (i.e. 100 μL DMSO 900 μL Corn oil)
Example: Take the Injection Formulation 3 (DMSO : Corn oil = 10 : 90) as an example, if 1 mL of 2.5 mg/mL working solution is to be prepared, you can take 100 μL 25 mg/mL DMSO stock solution and add to 900 μL corn oil, mix well to obtain a clear or suspension solution (2.5 mg/mL, ready for use in animals).
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Injection Formulation 4: DMSO : 20% SBE-β-CD in saline = 10 : 90 [i.e. 100 μL DMSO 900 μL (20% SBE-β-CD in saline)]
*Preparation of 20% SBE-β-CD in Saline (4°C,1 week): Dissolve 2 g SBE-β-CD in 10 mL saline to obtain a clear solution.
Injection Formulation 5: 2-Hydroxypropyl-β-cyclodextrin : Saline = 50 : 50 (i.e. 500 μL 2-Hydroxypropyl-β-cyclodextrin 500 μL Saline)
Injection Formulation 6: DMSO : PEG300 : castor oil : Saline = 5 : 10 : 20 : 65 (i.e. 50 μL DMSO 100 μLPEG300 200 μL castor oil 650 μL Saline)
Injection Formulation 7: Ethanol : Cremophor : Saline = 10: 10 : 80 (i.e. 100 μL Ethanol 100 μL Cremophor 800 μL Saline)
Injection Formulation 8: Dissolve in Cremophor/Ethanol (50 : 50), then diluted by Saline
Injection Formulation 9: EtOH : Corn oil = 10 : 90 (i.e. 100 μL EtOH 900 μL Corn oil)
Injection Formulation 10: EtOH : PEG300Tween 80 : Saline = 10 : 40 : 5 : 45 (i.e. 100 μL EtOH 400 μLPEG300 50 μL Tween 80 450 μL Saline)


Oral Formulations
Oral Formulation 1: Suspend in 0.5% CMC Na (carboxymethylcellulose sodium)
Oral Formulation 2: Suspend in 0.5% Carboxymethyl cellulose
Example: Take the Oral Formulation 1 (Suspend in 0.5% CMC Na) as an example, if 100 mL of 2.5 mg/mL working solution is to be prepared, you can first prepare 0.5% CMC Na solution by measuring 0.5 g CMC Na and dissolve it in 100 mL ddH2O to obtain a clear solution; then add 250 mg of the product to 100 mL 0.5% CMC Na solution, to make the suspension solution (2.5 mg/mL, ready for use in animals).
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Oral Formulation 3: Dissolved in PEG400
Oral Formulation 4: Suspend in 0.2% Carboxymethyl cellulose
Oral Formulation 5: Dissolve in 0.25% Tween 80 and 0.5% Carboxymethyl cellulose
Oral Formulation 6: Mixing with food powders


Note: Please be aware that the above formulations are for reference only. InvivoChem strongly recommends customers to read literature methods/protocols carefully before determining which formulation you should use for in vivo studies, as different compounds have different solubility properties and have to be formulated differently.

 (Please use freshly prepared in vivo formulations for optimal results.)
Preparing Stock Solutions 1 mg 5 mg 10 mg
1 mM 1.4289 mL 7.1445 mL 14.2890 mL
5 mM 0.2858 mL 1.4289 mL 2.8578 mL
10 mM 0.1429 mL 0.7144 mL 1.4289 mL

*Note: Please select an appropriate solvent for the preparation of stock solution based on your experiment needs. For most products, DMSO can be used for preparing stock solutions (e.g. 5 mM, 10 mM, or 20 mM concentration); some products with high aqueous solubility may be dissolved in water directly. Solubility information is available at the above Solubility Data section. Once the stock solution is prepared, aliquot it to routine usage volumes and store at -20°C or -80°C. Avoid repeated freeze and thaw cycles.

Calculator

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An example of molarity calculation using the molarity calculator is shown below:
What is the mass of compound required to make a 10 mM stock solution in 5 ml of DMSO given that the molecular weight of the compound is 350.26 g/mol?
  • Enter 350.26 in the Molecular Weight (MW) box
  • Enter 10 in the Concentration box and choose the correct unit (mM)
  • Enter 5 in the Volume box and choose the correct unit (mL)
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  • The answer of 17.513 mg appears in the Mass box. In a similar way, you may calculate the volume and concentration.

Dilution Calculator allows you to calculate how to dilute a stock solution of known concentrations. For example, you may Enter C1, C2 & V2 to calculate V1, as detailed below:

What volume of a given 10 mM stock solution is required to make 25 ml of a 25 μM solution?
Using the equation C1V1 = C2V2, where C1=10 mM, C2=25 μM, V2=25 ml and V1 is the unknown:
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  • The answer of 62.5 μL (0.1 ml) appears in the Volume (Start) box
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Note: Chemical formula is case sensitive: C12H18N3O4  c12h18n3o4
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In vivo Formulation Calculator (Clear solution)
Step 1: Enter information below (Recommended: An additional animal to make allowance for loss during the experiment)
Step 2: Enter in vivo formulation (This is only a calculator, not the exact formulation for a specific product. Please contact us first if there is no in vivo formulation in the solubility section.)
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Calculation results

Working concentration mg/mL;

Method for preparing DMSO stock solution mg drug pre-dissolved in μL DMSO (stock solution concentration mg/mL). Please contact us first if the concentration exceeds the DMSO solubility of the batch of drug.

Method for preparing in vivo formulation:Take μL DMSO stock solution, next add μL PEG300, mix and clarify, next addμL Tween 80, mix and clarify, next add μL ddH2O,mix and clarify.

(1) Please be sure that the solution is clear before the addition of next solvent. Dissolution methods like vortex, ultrasound or warming and heat may be used to aid dissolving.
             (2) Be sure to add the solvent(s) in order.

Clinical Trial Information
A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration
CTID: NCT02314299
Phase: Phase 1/Phase 2
Status: Completed
Date: 2015-10-26
A Phase 1 Study Examining the Pharmacokinetics and Tolerability of a Single Oral Dose of Bendavia (MTP-131)
CTID: NCT01754818
Phase: Phase 1
Status: Completed
Date: 2013-02-06
ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD)
CTID: NCT06373731
Phase: Phase 3
Status: Active, not recruiting
Date: 2025-11-17
FRDA Investigator Initiated Study (IIS) With Elamipretide
CTID: NCT05168774
Phase: Phase 1/Phase 2
Status: Completed
Date: 2025-12-12
A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function
CTID: NCT02436447
Phase: Phase 1
Status: Completed
Date: 2015-11-18
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of 4 Weeks Treatment with Subcutaneous Elamipretide on Left Ventricular Function in Subjects with Stable Heart Failure with Preserved Ejection Fraction
EudraCT: 2015-005615-32
Phase: Phase 2
Status: Completed
Date: 2016-05-18
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)
EudraCT: 2021-003907-16
Phase: Phase 3
Status: Completed
Date: 2022-03-02
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment with Elamipretide in Patients Hospitalized with Congestion due to Heart Failure
EudraCT: 2016-000126-19
Phase: Phase 2
Status: Completed
Date: 2016-08-01
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of Multiple Subcutaneous Injections of Elamipretide on Left Ventricular Function in Subjects with Stable Heart Failure with Reduced Ejection Fraction
EudraCT: 2014-005724-10
Phase: Phase 2
Status: Completed
Date: 2016-06-07
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 Myopathy Followed by an Open-Label Treatment Extension
EudraCT: 2017-002447-15
Phase: Phase 3 Status: Completed, Prematurely Ended Date: 2018-06-22
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