Barth syndrome muscle strength
Study
Forzinity's accelerated approval is disease-specific; confirmation of clinical benefit is required.1
Longevity
SS-31
Mitochondrial cardiolipin-binding peptide
Forzinity: FDA accelerated approval in 2025 for muscle strength in adults and children with Barth syndrome weighing at least 30 kg.
What does it do?
Energy and endurance
Community
Community claims extend beyond the approved population.5
Molecular information
2Amino-acid sequence
- D-Arg
- Dmt
- Lys
- Phe
4 residues · N → C11
Length4 amino acids
Molecular weight · Da749.2 Da (trihydrochloride)
Molecular formulaC32H49N9O5 · 3HCl2
dR–Dmt–K–FdR = D-arginine; Dmt = 2,6-dimethyltyrosine. C-terminal amide. The approved label gives D-Arg–2,6-dimethyl-Tyr–Lys–Phe–NH2.
This is the Forzinity salt. Labeled dose is expressed as elamipretide equivalent.
Pharmacokinetics
Human data
Reported half-life2.8 hours (study mean)3
Route / formulationSubcutaneous clinical-study elamipretide (SPISC-102)
50%of reference level
Illustrative model using reported human data.
About 3% remaining after 14 h
Five half-lives in this simplified model. This is not a prediction of when effects stop.
About this estimate
FDA integrated review Table 7 reports mean steady-state half-life 2.8 hours (SD 0.3) after 40 mg daily for seven days. This study estimate is not a measured curve for a retail SS-31 powder. The approved label itself gives no numerical half-life.
Population: Healthy volunteers; five participants in the cited 40-mg cohort
100 × 2−time / half-life. Time zero is a reference level, not the moment of administration. Absorption, repeated dosing, metabolites and clinical effects are not modeled. Five half-lives leaves 3.125%, not zero. This curve cannot determine a dosing interval.
Unverified reference estimateNot independently confirmed
Reference half-life4 hours12
Route / formulationSource page: Injectable. Exact PK route not verified.
The checked subcutaneous study mean is 2.8 hours. The source’s 4-hour value is retained as a separate reference claim.
50%of reference level
Illustrative scenario using an unverified reference estimate.
About 3% remaining after 20 h
Five half-lives in this estimated model. This is not a prediction of when effects stop.
About this estimate
Population: Not established by the reference estimate
Source’s stated attribution: Stealth BioTherapeutics trials
Source’s reported peak time: 30 min. This has not been independently confirmed and is not used in the elimination curve.
100 × 2−time / half-life. Time zero is a reference level, not the moment of administration. Absorption, repeated dosing, metabolites and clinical effects are not modeled. Five half-lives leaves 3.125%, not zero. This curve cannot determine a dosing interval.
What to expect
Study outcomes
Randomized primary outcomes were negative
The trial did not show superiority on walking distance or fatigue. Muscle-strength gains emerged during the uncontrolled extension.1
Reported timelines
Reference & communitySource expectations
Energy days 1–3; endurance weeks 1–2; stamina/sleep weeks 2–4; exercise/biomarkers weeks 4–12. Not validated healthy-user forecasts.13
These are reported timelines, not a prediction of your response.
Doses & schedules
Route
Scroll to compare all columns →
| Route | Dose | Frequency | Goal / evidence | Duration | References |
|---|---|---|---|---|---|
| SubQSubcutaneous | 40 mg | Once daily | Barth syndrome function12 participants aged ≥12 years and weighing >30 kgHuman study | 12 weeks per randomized treatment period | 1 |
Population 12 participants aged ≥12 years and weighing >30 kg Context Crossover trial, followed by an open-label extension. | |||||
| SubQSubcutaneous | 40 mg | Daily | ReCLAIM-2 geographic-atrophy trial176 adults aged at least 55 with dry AMD and noncentral geographic atrophyHuman study | 48 weeks; 4-week follow-up | 4 |
Population 176 adults aged at least 55 with dry AMD and noncentral geographic atrophy Context Studied under protocol supervision; this is not a self-administration recommendation. | |||||
| SubQ | 5-10 mg | Once daily | General Mitochondrial SupportReference report | 4-12 weeks continuous use | 13 |
Population Population not independently verified; see the reference and linked research. Context Reported in Pep-Pedia’s educational protocol table. Study attribution and applicability to this exact product are not independently established. Topical and general-wellness claims are separate from approved injectable use; source stack labels do not prove safety. Source tabs Injectable | |||||
| SubQ | 10-20 mg | Once daily pre-workout | Athletic PerformanceReference report | 4-12 weeks continuous use | 13 |
Population Population not independently verified; see the reference and linked research. Context Reported in Pep-Pedia’s educational protocol table. Study attribution and applicability to this exact product are not independently established. Topical and general-wellness claims are separate from approved injectable use; source stack labels do not prove safety. Source tabs Injectable | |||||
| SubQSubcutaneous | 40 mg | Once daily | Clinical ProtocolsReference report | 4-12 weeks continuous use | 13 |
Population Population not independently verified; see the reference and linked research. Context Reported in Pep-Pedia’s educational protocol table. Study attribution and applicability to this exact product are not independently established. Topical and general-wellness claims are separate from approved injectable use; source stack labels do not prove safety. Source route wording SubQ or IV Source tabs Injectable | |||||
| IVIntravenous | 40 mg | Once daily | Clinical ProtocolsReference report | 4-12 weeks continuous use | 13 |
Population Population not independently verified; see the reference and linked research. Context Reported in Pep-Pedia’s educational protocol table. Study attribution and applicability to this exact product are not independently established. Topical and general-wellness claims are separate from approved injectable use; source stack labels do not prove safety. Source route wording SubQ or IV Source tabs Injectable | |||||
| IV | 0.25 mg/kg/hr | Continuous infusion | Acute CardioprotectionReference report | 4-12 weeks continuous use | 13 |
Population Population not independently verified; see the reference and linked research. Context Reported in Pep-Pedia’s educational protocol table. Study attribution and applicability to this exact product are not independently established. Topical and general-wellness claims are separate from approved injectable use; source stack labels do not prove safety. Source tabs Injectable | |||||
| Topical | 0.5% cream | Twice daily | Anti-aging skincareReference report | Continuous use | 13 |
Population Population not independently verified; see the reference and linked research. Context Reported in Pep-Pedia’s educational protocol table. Study attribution and applicability to this exact product are not independently established. Topical and general-wellness claims are separate from approved injectable use; source stack labels do not prove safety. Source tabs Topical | |||||
| TopicalTopical to affected area | 1% gel | 2-3x daily | Wound healing supportReference report | Continuous use | 13 |
Population Population not independently verified; see the reference and linked research. Context Reported in Pep-Pedia’s educational protocol table. Study attribution and applicability to this exact product are not independently established. Topical and general-wellness claims are separate from approved injectable use; source stack labels do not prove safety. Source tabs Topical | |||||
No protocols match these filters.
Study and label doses retain their study context. Reference reports are unvalidated practices, not personal treatment instructions. Ranges remain ranges; escalation stages are labeled.
Reported use periods and breaks. These do not establish a safe cycle or prove that breaks prevent tolerance.
Injectable
- Use period
- 4-12 weeks continuous use
- Break
- No mandatory break required - can be used continuously
Reported timing
Morning for general use, pre-workout for performance, or as directed for clinical protocols
Topical
- Use period
- Continuous use
- Break
- Not required
Reported timing
Morning and evening after cleansing
Side effects & safety
Injection-site reactions
The approved product commonly causes local reactions.
2Allergic reactions
Serious hypersensitivity has occurred.
2Kidney impairment
Severe renal impairment requires product-specific dose adjustment; dialysis was not studied.
2AMD-trial adverse events
Adverse events occurred in 86% with elamipretide versus 71% with placebo; injection-site reactions were most common.
4Safety
Injection reactions are common; serious reactions reported. General long-term “safe” claims exceed evidence.
Stop symptoms
Severe local reactions, allergy, unusual weakness/fatigue, cardiovascular symptoms or headache/vision changes.
Not a complete safety screen. Discuss health decisions with a qualified clinician.
Combinations & interactions
7 entriesCheck cautions and reported pairings. A compatibility claim does not establish that a combination is safe.
NAD+
Unverified pairingUnproven mitochondrial stack.13
Reference report · Pep-Pedia label: SynergisticMOTS-c
Unverified pairingUntested pairing.13
Reference report · Pep-Pedia label: SynergisticHumanin
Unverified pairingUntested pairing.13
Reference report · Pep-Pedia label: SynergisticGHK-Cu
Unverified pairingUntested pairing.13
Reference report · Pep-Pedia label: CompatibleBPC-157
Unverified pairingUntested pairing.13
Reference report · Pep-Pedia label: CompatibleThymosin Beta-4
Unverified pairingUntested pairing.13
Reference report · Pep-Pedia label: CompatibleAspirin, clopidogrel or heparin
Human studySpecific IV studies found no meaningful effect on the tested drug exposure or antithrombotic measures. This does not establish all combinations as safe.2
Research contextNo matching interactions. Try another name or filter.
Reconstitution calculator
Enter your peptide amount and container size. Get a volume and a simple measurement scale.
Suggested final volume mL
Estimated water to add≈ mL
For dry powder, assuming negligible volume displacement. Use bacteriostatic water only if the formulation specifies it.
1 pen unit (one dial step)=
Amounts below are total blend mass. Ingredient amounts are listed separately.
| Pen units | Amount | Volume |
|---|
Ingredients per unit
Other simple scales
Convert a specific amount
Enter an amount to calculate its volume and device setting.
Calculation & assumptions
The suggestion favors a simple 1, 2, or 5 × power-of-ten amount per unit, then the largest final volume that fits. It does not choose a dose or a biologically suitable concentration.
The water estimate applies only to dry powder and assumes negligible powder displacement. Final solution volume, specified diluent, solubility, stability, sterility, cartridge compatibility, and working fill limits must be established separately. No allowance is made for priming or transfer losses.
V2 measurement specification ↗Bacteriostatic water: formulation instructions ↗Reconstitution
Forzinity is supplied as an 80 mg/mL aqueous solution.2
No powder preparation
No diluent is added. This formulation does not validate preparation of research SS-31 powders.2
Reference preparation details
Reported handling information, not a validated formulation or instruction to prepare an injectable product.
Injectable
The source gives a research-powder example, distinct from approved product handling.
- Solvents mentioned
- Bacteriostatic water
- Reported parameters
- 10 mg in 1–2 mL gives 10–5 mg/mL. · Reported storage: refrigeration after mixing.
The source’s IV-filtration suggestion does not validate sterility or a home IV formulation.
Topical
The topical tab repeats injectable preparation text.
It does not establish a topical formulation, concentration or shelf life.
Appearance & documentation
Appearance and a purity certificate cannot establish sterility, identity, or suitability for injection.
Reported appearancePharmaceutical gradeReported appearanceClear solutionReported appearanceCOA availableReported variationLight sensitiveReported variationpH considerationsReported concernDiscoloration
13Vial sizes
Packaging examples, not a market survey. Approved and research products are not interchangeable.
Storage after mixing
Reconstituted research vials
Pep-Pedia reports these handling limits after mixing. They are not validated stability or sterility limits for your vial.
Ready-made products
Product-specific storage; no reconstitution.
Forzinity
2Already a solution; no reconstitution. Do not freeze. Its 8-day limit does not validate the reported 30-day period for research powder.
Storage notes
13Refrigerate after reconstitution, protect from light, use within 30 days
Room temperature, away from heat and light
Storage depends on the formulation, diluent, container, and handling. Follow the specific product label or pharmacist’s instructions.
Pen & syringe measurements
Device units measure volume. Concentration determines the amount in mg.
1 notch = 0.01 mL
Documented 1-unit V2 models
- One dial increment
- 1 unit
- Cartridge capacity
- 3 mL
- Maximum setting
- 60 units · 0.60 mL
Use the numbered dose window. Whole-unit settings only; confirm the specification for your exact model.
1 unit = 0.01 mL
100 units = 1 mL
- 10 units
- 0.10 mL
- 30-unit capacity
- 0.30 mL
- 50 / 100-unit capacity
- 0.50 / 1 mL
Read the printed unit scale. A small line may represent 0.5, 1, or 2 units depending on the syringe.
Use the mL scale
mL syringes and calibrated pipettes
- 0.01 mL
- 10 µL
- 0.10 mL
- 100 µL
- Amount
- mL × mg/mL
Drops, sprays and other pen clicks need their own verified volume per increment. They have no universal conversion.
3 mL is cartridge capacity. It does not mean you must prepare or load 3 mL. The original vial and the pen cartridge are different containers. This reference compares measurement scales; it does not establish product or route compatibility.
Device references
AVERON V2 specifications ↗SilverLeaf V2 unit reference ↗FDA: syringe unit conversions ↗Specifications checked October 12, 2026.Evidence limits
View findings →Broad longevity, cognitive and athletic claims are not established by the Barth-syndrome indication.1
3 distinct primary sources or abstracts checked. Evidence may concern a parent compound, individual blend ingredient, animal, or cell model; it does not necessarily establish a benefit for this exact product.
Evidence definitions →Research findings
Human trialsSource context
Topical and general-wellness claims are separate from approved injectable use; source stack labels do not prove safety.
Compound identity & other names
Elamipretide binds mitochondrial cardiolipin. Forzinity gained accelerated FDA approval for improving muscle strength in Barth syndrome; this is not approval for general anti-aging or athletic performance.
Other names: Elamipretide · Forzinity · MTP-131 · Bendavia · SS-31 (Elamipretide)
Forzinity: FDA accelerated approval in 2025 for muscle strength in adults and children with Barth syndrome weighing at least 30 kg.
Elamipretide; mitochondrial cardiolipin-binding tetrapeptide.2
How it may work
Binds mitochondrial cardiolipin, influencing membrane organization and respiratory function.13
The randomized phase did not meet its primary endpoints
In 12 patients, elamipretide was not superior to placebo for walking distance or fatigue during the initial 12-week randomized crossover trial.
1Approval used longer-term muscle-strength observations
Knee-extensor strength improved during the open-label extension, not the randomized phase. Confirmatory evidence is required under accelerated approval.
1AMD trial missed both primary endpoints
ReCLAIM-2 did not show statistically significant improvement in its two primary endpoints: low-luminance visual acuity and square-root geographic-atrophy area. Secondary imaging signals do not establish clinical efficacy.
4Source checks & newer research
FDA Forzinity drug-trial snapshot
Accelerated approval September 19, 2025 to improve muscle strength in Barth syndrome at body weight ≥30 kg; core trial enrolled 12 patients. Approval does not establish anti-aging or healthy-user endurance benefits.
FDA approval/trial summary14Research areas and evidence gaps
Barth syndrome muscle strength. Forzinity's accelerated approval is disease-specific; confirmation of clinical benefit is required.1
- Broad longevity, cognitive and athletic claims are not established by the Barth-syndrome indication.
- A tiny rare-disease cohort cannot define effects in healthy adults.
Additional uses listed by Pep-Pedia
Approved use. Muscle strength in Barth syndrome, patients at least 30 kg.13
Research. Mitochondrial disease, cardiac function and exercise tolerance.13
Community / preclinical. Energy, muscle, cognition, aging, skin/photoaging and wound-repair claims.13
Community reports Unvalidated
Pep-Pedia describes community interest in energy and exercise endurance. Those claims extend beyond the approved disease population.5
A secondary protocol description, not a clinical recommendation or a representative survey. Dose, product identity, other compounds and outcome reporting are not independently verified.
Search coverage and review status
The targeted check identified relevant additional literature or current regulatory information; checked findings are separated from retained bibliography-only references.
- Checked
- 2026-10-12
- Search
- elamipretide 2025 2026 trial site:pubmed.ncbi.nlm.nih.gov
- Catalog
- Pep-Pedia ↗ · 4 listed references retained
- Targeted search, not an exhaustive systematic review.
- Bibliography-only entries are retained for traceability and are not treated as verified findings.
AI-prepared summaries. Independent medical editorial review is pending.
Community poll 10 topics · Pep-Pedia snapshot
Voluntary, unverified reports. These percentages do not measure effectiveness or safety.
Experience
The source hides 2 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Duration of use
The source hides 10 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Age range
The source hides 1 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Gender
Number of responses to this question: not disclosed.
Primary goal
The source hides 24 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Effectiveness
The source hides 26 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Side effects
The source hides 18 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Dosage frequency
The source hides 7 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Would recommend
The source hides 8 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
How discovered
The source hides 3 additional categories. Their labels and percentages are unavailable.
Number of responses to this question: not disclosed.
Source & limitations
The source displays “2893 responses” for this profile. This is not a confirmed participant count or a denominator for individual questions.
- Voluntary self-reports from Pep-Pedia visitors; identity, treatment, outcomes and timing are unverified. These data are not efficacy or safety estimates.
- The source displays a profile-wide response label, not a confirmed unique participant count. It stays unchanged across questions. Question-specific denominators and absolute option counts are not exposed.
- Only the top five categories are displayed for some questions. Extra categories are retained as an undisplayed-category count; their labels and percentages are unavailable.
- Displayed percentages are rounded. They may not total 100%, especially where categories are hidden.
- This is a dated snapshot, not a live survey or current recommendation.
References
Original sources and review status. Open a reference to read its summary.
1FDA drug-trial snapshot: ForzinityReview status not recorded
AI-PREPARED SUMMARY
The randomized phase did not beat placebo on walking distance or fatigue. Accelerated approval relied on muscle-strength improvement in the extension.
The randomized phase did not meet its primary endpoints
In 12 patients, elamipretide was not superior to placebo for walking distance or fatigue during the initial 12-week randomized crossover trial.
Approval used longer-term muscle-strength observations
Knee-extensor strength improved during the open-label extension, not the randomized phase. Confirmatory evidence is required under accelerated approval.
2Forzinity prescribing informationReview status not recorded
AI-PREPARED SUMMARY
The approved product is a daily subcutaneous treatment for a defined Barth-syndrome population; it has hypersensitivity and injection-site warnings.
3FDA integrated review: human elamipretide pharmacokineticsReview status not recorded
AI-PREPARED SUMMARY
Table 7 reports a 2.8-hour mean steady-state half-life in five healthy volunteers after seven daily 40-mg subcutaneous doses (SPISC-102). The review also gives a broader approximate 3–4-hour elimination summary.
4ReCLAIM-2: elamipretide in geographic atrophyAbstract checked
AI-PREPARED SUMMARY
Online October 2024, 2025 issue. In 176 participants, 40 mg daily for 48 weeks missed both primary visual-acuity and atrophy-area endpoints; favorable secondary imaging findings were nominal.
AMD trial missed both primary endpoints
ReCLAIM-2 did not show statistically significant improvement in its two primary endpoints: low-luminance visual acuity and square-root geographic-atrophy area. Secondary imaging signals do not establish clinical efficacy.
Additional research · Checked 2026-10-12
5Pep-Pedia: ss-31 — community referenceCommunity source checked
AI-PREPARED SUMMARY
Accessed October 12, 2026. Reports commonly discussed protocols; these schedules are unvalidated descriptions, not evidence of safety or efficacy.
6Research catalog: labeled vial examplesCatalog checked
AI-PREPARED SUMMARY
Catalog lists 10 mg and 50 mg research presentations. These are seller label examples, not verified contents, market-frequency estimates or supplier endorsements.
7FDA Forzinity review: Barth-syndrome muscle-strength indication (2025)Primary source checked
AI-PREPARED SUMMARY
Accelerated approval September 19, 2025 to improve muscle strength in Barth syndrome at body weight ≥30 kg; core trial enrolled 12 patients. Approval does not establish anti-aging or healthy-user endurance benefits.
Pep-Pedia bibliography; reconciled with an existing checked primary-source record · Checked 2026-10-12
8Phase 2 Trial for Primary Mitochondrial Myopathy (2018)Pep-Pedia report · Primary source not checked
AI-PREPARED SUMMARY
Pep-Pedia reports: The card claims improved walking/fatigue in mitochondrial myopathy; its population, duration and endpoints need checking against the named trial.
Reported population / model
Human
Reported study details
40mg daily · 12 weeks · 36 patients
Pep-Pedia supplies no original study link for this card. Study identity, design, doses and result remain unverified.
Read the Pep-Pedia report ↗Pep-Pedia reference card; original summary of its reported findings · Checked 2026-10-12
9Cardioprotection in Heart Failure Model (2019)Pep-Pedia report · Primary source not checked
AI-PREPARED SUMMARY
Pep-Pedia reports: Cardiac-injury benefits around surgery are claimed without a primary-study link; exact population and endpoint attribution remain unresolved.
Reported population / model
Human
Reported study details
0.25mg/kg/hr infusion · During cardiac surgery
Pep-Pedia supplies no original study link for this card. Study identity, design, doses and result remain unverified.
Read the Pep-Pedia report ↗Pep-Pedia reference card; original summary of its reported findings · Checked 2026-10-12
10Age-Related Muscle Dysfunction Study (2020)Pep-Pedia report · Primary source not checked
AI-PREPARED SUMMARY
Pep-Pedia reports: Aged-mouse muscle experiments reportedly improved function, ATP and oxidative-stress measures; healthy-user clinical benefit is unestablished.
Reported population / model
Animal model
Reported study details
Various doses · 8 weeks · Aged mice
Pep-Pedia supplies no original study link for this card. Study identity, design, doses and result remain unverified.
Read the Pep-Pedia report ↗Pep-Pedia reference card; original summary of its reported findings · Checked 2026-10-12
11DailyMed: FORZINITY molecular sequencePrimary source checked
AI-PREPARED SUMMARY
Sequence and modifications checked October 12, 2026. dR = D-arginine; Dmt = 2,6-dimethyltyrosine. C-terminal amide. The approved label gives D-Arg–2,6-dimethyl-Tyr–Lys–Phe–NH2.
12Pep-Pedia: SS-31 — reported pharmacokineticsReference estimate; not independently verified human PKCommunity source checked
AI-PREPARED SUMMARY
Lists a half-life of 4 hrs and a peak time of 30 min. Stated attribution: Stealth BioTherapeutics trials. The checked subcutaneous study mean is 2.8 hours. The source’s 4-hour value is retained as a separate reference claim. Five half-lives is not complete clearance, and the source’s “cleared” value is not used as a measured endpoint.
Secondary reference page checked; the underlying quantitative claim is not independently confirmed. · Checked 2026-10-12
13Pep-Pedia: SS-31 — route-specific referenceReference page checked; underlying claims require separate verification.Community source checked
AI-PREPARED SUMMARY
Source page checked across available routes. Protocols, cycles, storage, mechanisms and pairing claims are secondary reports; checking the page does not independently validate those claims. Original concise summaries are used here.
Content coverage audit · Checked 2026-10-12
14FDA Forzinity drug-trial snapshotPrimary source checked
AI-PREPARED SUMMARY
Accelerated approval September 19, 2025 to improve muscle strength in Barth syndrome at body weight ≥30 kg; core trial enrolled 12 patients. Approval does not establish anti-aging or healthy-user endurance benefits.
FDA Forzinity drug-trial snapshot
Accelerated approval September 19, 2025 to improve muscle strength in Barth syndrome at body weight ≥30 kg; core trial enrolled 12 patients. Approval does not establish anti-aging or healthy-user endurance benefits.
Additional primary-source check · Checked 2026-10-12