An FDA-approved prescription product containing elamipretide exists under the brand name Forzinity. On September 19, 2025, FDA granted Forzinity accelerated approval to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kilograms. This approval applies only to the approved product, formulation, manufacturing system, population and labeled indication. The Ryse SS-31 product is separate laboratory-research material. It is not Forzinity, generic Forzinity or an FDA-approved prescription product and should not be assumed pharmaceutically or clinically equivalent. Last verified July 27, 2026.
What Researchers Study This Peptide For
Published research has examined this peptide in laboratory, animal and, where available, human studies involving the following areas:
Evidence represented: Laboratory • Animal • Human clinical
- Mitochondrial membrane biologyMechanistic
- Cardiolipin-related researchLaboratory
- Cellular energy productionLaboratory and animal
- Oxidative-stress measurementsLaboratory and animal
- Mitochondrial-disease clinical researchHuman clinical
- Muscle and cardiac research modelsAnimal and human
These topics describe areas of scientific investigation. Findings vary by study design, research model, formulation and evidence quality and should not be interpreted as established human outcomes.
What should you know first?
What Is SS-31?
SS-31 is a synthetic peptide composed of four amino acids and designed for research involving mitochondrial membranes.
It is commonly called elamipretide in pharmaceutical and clinical research. Laboratory work examines its association with cardiolipin and measurements involving mitochondrial structure, electron transport and cellular-energy pathways.
Those measurements do not establish a general human benefit or verify a Ryse product.
What Does the Name SS-31 Mean?
SS-31 belongs to a research group called Szeto–Schiller peptides; the initials refer to scientists associated with the class, and the number identifies this peptide in the series.
Older publications may use SS-31, MTP-131 or Bendavia. Elamipretide is the pharmaceutical or nonproprietary name.
Is SS-31 the Same as Elamipretide?
The names can refer to the same intended peptide sequence in scientific literature, but a shared name does not make different products equivalent.
- SS-31 is a research or development name.
- Elamipretide is the pharmaceutical or nonproprietary name.
- MTP-131 and Bendavia occur in older development records.
- Products may differ in salt, formulation, concentration and manufacturing controls.
- Ryse material is not Forzinity or verified pharmaceutical material.
Mitochondria, Cardiolipin and SS-31 Research
Mitochondria are cellular structures involved in energy conversion, signaling, metabolic regulation and programmed cell responses.
Cardiolipin is a specialized lipid found mainly in the inner mitochondrial membrane, where it is associated with membrane structure, cristae and electron-transport proteins. Researchers study SS-31 interactions with cardiolipin using biochemical assays, isolated mitochondria, cell cultures, animal models and clinical studies.
Measuring mitochondrial activity in any model does not by itself establish a health result in people.
SS-31 Versus MOTS-c
SS-31 and MOTS-c both appear in mitochondrial research, but they are different molecules with different origins, structures and research contexts.
SS-31
- Synthetic tetrapeptide
- Also known as elamipretide
- Studied in cardiolipin and mitochondrial-membrane research
- Has a specific FDA-approved pharmaceutical form for one narrow indication
- Ryse SS-31 is not that approved product
MOTS-c
- Mitochondrial-derived peptide encoded within mitochondrial DNA
- Commonly described as 16 amino acids
- Studied in metabolic-signaling and cellular-stress models
- Does not share SS-31’s structure
- Is not interchangeable with SS-31
What questions are researchers studying?
Published work examines SS-31 or pharmaceutical elamipretide in tightly defined laboratory, animal and clinical settings.
These are research contexts, not claims that Ryse SS-31 is approved, pharmaceutically equivalent, safe, effective or suitable for personal use.
- Cardiolipin, inner-membrane and cristae research
- Electron-transport and cellular-respiration measurements
- Oxidative-stress and ATP-related laboratory measurements
- Skeletal-muscle and primary mitochondrial myopathy research
- Barth syndrome clinical research
- Cardiovascular, kidney, neurological and retinal research models
- Pharmacokinetics, peptide stability and analytical identity
What should you know first?
Evidence status: extensive preclinical research, human clinical research and one narrow FDA-approved use for a specific prescription product.
The evidence includes biochemical and cell studies, animal models, phase 1 through phase 3 research, extension studies and accelerated approval for Forzinity’s labeled indication.
- The evidence does not establish approval for general mitochondrial support, fatigue, athletic performance, aging, longevity, cardiovascular or neurological conditions.
- It does not establish equivalence between Ryse SS-31 and Forzinity.
- It does not establish research-product injectable safety, personal dosing or self-administration.
- It does not verify a particular commercial batch.
What do human studies tell us?
Preclinical models can clarify mechanisms and support decisions about human trials, but their findings cannot automatically be applied to people.
Broader SS-31 research examines mitochondrial membranes, cardiolipin, electron transport, cellular respiration, oxidative-stress markers and tissue responses under experimental stress. Findings depend on the model and measured endpoint.
Pharmaceutical elamipretide has been studied in Barth syndrome, primary mitochondrial myopathy, retinal, cardiovascular, kidney and muscle-function settings. Outcomes vary by population, trial phase, endpoint, duration and formulation.
The phase 3 MMPOWER-3 trial did not meet its primary walking-distance or fatigue endpoints. Clinical research involving regulated pharmaceutical material does not establish Ryse-product quality, sterility, equivalence or human safety.
What is its regulatory status?
Forzinity and Ryse SS-31 are separate products with different regulatory and quality contexts.
FDA-approved Forzinity
- Contains elamipretide isolated as a hydrochloride salt
- Accelerated approval for a defined Barth syndrome indication
- For patients weighing at least 30 kg
- Manufactured under an approved application and FDA labeling
- Continued approval may depend on confirmatory evidence
Ryse SS-31
- Laboratory research only
- Not Forzinity or generic Forzinity
- Not an FDA-approved drug and has no approved indication
- Salt form is not specified by verified catalog and label records
- Requires batch-specific analytical review
Sharing the terms SS-31 or elamipretide does not establish identical salt, formulation, purity, sterility, manufacturing controls, pharmaceutical equivalence or clinical performance.
What are the limits of the current evidence?
FDA approval is narrow and applies only to Forzinity; broader SS-31 findings remain condition-, formulation- and model-specific.
- Forzinity received accelerated approval, and continued approval may depend on confirmatory evidence.
- Not every clinical trial met its primary endpoints.
- Laboratory and animal findings do not establish human effectiveness or safety.
- Clinical-trial material is not automatically equivalent to commercial research material.
- Published studies do not verify a Ryse batch.
- A COA does not establish pharmaceutical equivalence, human safety or FDA approval.
- Research findings provide no personal-use instructions.
Product Identity and SS-31 COA Documentation
A label reading SS-31 or elamipretide does not establish the exact peptide form, quality or pharmaceutical equivalence.
The repository verifies Ryse 10 mg and 50 mg SS-31 catalog records, labels identifying SS-31/Elamipretide or 50 mg vial, and one bundled COA titled SS-31 10mg. The 10 mg record is used as the matching documented product.
The verified catalog and label do not identify acetate, hydrochloride or another salt, so no Ryse salt form is assigned here.
Purity estimates relative composition under a stated method; identity evaluates consistency with an expected molecule. Salt-form verification, sterility and endotoxin require separate evidence.
None establishes Forzinity origin, approval or human safety.
- Match product, strength, batch or lot, laboratory and test date.
- Check whether SS-31 or elamipretide and an exact salt or counterion are identified.
- Compare theoretical and observed molecular masses.
- Review chromatography, mass-spectrometry data and report limitations.
- Confirm identity and purity are reported separately.
- Reject unsupported Forzinity-equivalence or sterility claims.
How should laboratories approach storage and handling?
Follow verified product-specific documentation and institutional procedures for the exact peptide and molecular form.
No product-specific storage temperature or Ryse salt form was verified in the catalog or label, so neither is supplied here. Forzinity handling instructions are not transferred to Ryse material.
No solvent, preparation, route, dose or personal-use instructions are provided.
- Maintain accurate product and batch identification.
- Record storage conditions, duration and transfers.
- Review stability documentation for the exact form.
- Protect material from environmental exposure only where specified.
- Follow institutional handling and applicable disposal procedures.
Frequently Asked Questions
What is SS-31?
A synthetic, mitochondria-targeting tetrapeptide studied in cardiolipin and inner-membrane research.
Is SS-31 the same as elamipretide?
The names may describe the same intended peptide in literature, but different products are not automatically equivalent.
What does SS-31 stand for?
SS refers to the Szeto–Schiller peptide class; 31 identifies this peptide within the research series.
What type of peptide is SS-31?
A synthetic, aromatic-cationic, mitochondria-targeting peptide.
How many amino acids are in SS-31?
Four; scientific and FDA sources describe elamipretide as a tetrapeptide.
What are mitochondria?
Cellular structures involved in energy conversion, metabolic regulation, signaling and programmed cell responses.
What is cardiolipin?
A specialized lipid found mainly in the inner mitochondrial membrane and associated with its structure and proteins.
Why do researchers study SS-31?
To examine cardiolipin interactions, mitochondrial membranes, cellular measurements and defined clinical questions.
Are there human studies involving SS-31?
Yes. Pharmaceutical elamipretide has been studied in several defined populations, with mixed results across programs.
Is SS-31 FDA approved?
An FDA-approved prescription product containing elamipretide exists under the brand name Forzinity for one specific indication. Ryse SS-31 is not Forzinity and is not FDA approved.
What is Forzinity?
An FDA-approved prescription elamipretide product for a specific Barth syndrome indication.
What is Forzinity approved for?
It received accelerated approval to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kilograms.
What does accelerated approval mean?
FDA may approve a product using a surrogate or intermediate endpoint, with continued approval potentially requiring confirmatory evidence.
Is Ryse SS-31 the same as Forzinity?
No. Ryse SS-31 is separate laboratory-research material, not Forzinity, generic Forzinity or a verified pharmaceutical equivalent.
Is SS-31 approved for fatigue or anti-aging?
No. Forzinity’s approval does not cover general fatigue, athletic performance, mitochondrial support, anti-aging or longevity.
Is SS-31 the same as MOTS-c?
No. SS-31 is a synthetic tetrapeptide; MOTS-c is a different mitochondrial-derived peptide.
Is SS-31 intended for human consumption?
Ryse SS-31 is not. It is intended only for legitimate laboratory research.
What does an SS-31 COA show?
It may report selected identifiers, analytical methods and results for a defined sample and batch.
Does a COA prove equivalence to Forzinity?
No. It does not establish pharmaceutical, bioequivalence, manufacturing, approval or human-safety claims.
Does a COA prove safety?
No. A COA reports selected tests, not general human safety.
What is the difference between identity and purity?
Identity evaluates consistency with an expected molecule; purity estimates relative composition under a stated method.
Is this page medical advice?
No. It provides research-literacy information and no medical or personal-use guidance.
Selected SS-31 Studies
External publications and clinical-trial records are provided for scientific-literacy purposes. FDA approval applies only to the approved Forzinity product and labeled indication. Inclusion does not establish that the Ryse research product is equivalent, approved, safe, effective or suitable for personal use.
FORZINITY (elamipretide) injection — Prescribing Information
The official label verifies the approved product, elamipretide hydrochloride description, labeled indication and accelerated-approval context.
The mitochondria-targeted peptide SS-31 binds lipid bilayers and modulates surface electrostatics as a key component of its mechanism of action
A peer-reviewed membrane-biophysics study examining SS-31 interactions with lipid bilayers and cardiolipin-related systems.
Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical Trial
A phase 3 trial that did not meet its primary walking-distance or fatigue endpoints, illustrating limits on generalizing elamipretide findings.
Research Use Only
Information on this page is provided solely for general scientific education and laboratory-research literacy. It is not medical or veterinary advice and does not provide dosing, reconstitution, administration or personal-use guidance.
An FDA-approved prescription product containing elamipretide exists under the brand name Forzinity. Forzinity received accelerated approval to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kilograms. That approval applies only to the specific approved product, manufacturing process, formulation, population and labeled indication.
The Ryse SS-31 product is a separate laboratory-research material. It is not Forzinity, generic Forzinity or an FDA-approved prescription product and should not be assumed pharmaceutically equivalent, bioequivalent or clinically interchangeable with approved or investigational elamipretide.
Ryse Peptides products are intended only for legitimate laboratory research where legally permitted. They are not intended for human or veterinary consumption and are not intended to diagnose, treat, cure, mitigate or prevent disease.