InfoSynergy
Coenzyme Q10
CoQ10 is often used in mitochondrial care, but it does not replace Forzinity or prove off-label benefit.
Recommendation: Coordinate mitochondrial supplements with the treating specialist.
Elamipretide (SS-31)
Peptide ·Moderate evidence ·Reviewed May 2026
Elamipretide is a mitochondria-targeting tetrapeptide that binds cardiolipin on the inner mitochondrial membrane. As of September 19, 2025, Forzinity (elamipretide) is FDA-approved under accelerated approval to improve muscle strength in adults and children with Barth syndrome weighing at least 30 kg; all wellness, longevity, myopathy, heart failure, and fatigue uses remain investigational or off-label. It should be handled as a prescription specialty drug where approved, not a research peptide supplement.
What it's good for
- FDA accelerated approval for Barth syndrome muscle strength in patients weighing at least 30 kg, with confirmatory evidence still important3
- Cardiolipin-binding mitochondrial mechanism1,2
- Studied in primary mitochondrial myopathy and other mitochondrial disorders1,2
- Off-label longevity use is not established
The bottom line
Evidence rating moderate. Most-documented uses: fda accelerated approval for barth syndrome muscle strength in patients weighing at least 30 kg, with confirmatory evidence still important, cardiolipin-binding mitochondrial mechanism, studied in primary mitochondrial myopathy and other mitochondrial disorders. 3 sources indexed (2020–2025), with 3 interaction records on file.
The science
How it works, mechanistically.
Core mechanism
Elamipretide localizes to the inner mitochondrial membrane and associates with cardiolipin, helping stabilize cristae structure, electron transport, and ATP production while reducing pathologic reactive oxygen species in models. Clinical trial results have varied by disease: Barth syndrome received accelerated approval based on muscle-strength data, while primary mitochondrial myopathy phase 3 endpoints were not met. Injection-site reactions are common.1,2
Class
Mitochondrial cardiolipin-binding tetrapeptide
Found in food
None as a dietary supplement
Low-status signs
No recognized dietary deficiency state exists for this peptide
Dosing
Dosing & protocol.
Common range
Forzinity label: 40 mg subcutaneously once daily for indicated Barth syndrome patients; no approved wellness dose
Recommended form
FDA-approved Forzinity under specialist prescription for Barth syndrome; avoid research products
Approved product is subcutaneous injection. Oral research products are not established substitutes.
Forms
Forms & what to buy.
Ranked by evidence and value.
Forzinity Injection Recommended
FDA-approved subcutaneous elamipretide product for indicated Barth syndrome patients. Use exactly per prescribing information.
Clinical-Trial Elamipretide
Investigational use for non-Barth indications. Protocol-specific monitoring.
Research SS-31 Product
Not a substitute for FDA-approved product. Identity and sterility are uncertain.
Cost
What it actually costs.
Real-world pricing across three quality tiers. Assumes FDA-approved specialty injection.
BudgetBest value
$9000 /mo
$300 per dose
Mid
$27000 /mo
$900 per dose
Premium
$75000 /mo
$2500 per dose
Specialty-drug costs and coverage vary widely; research products are not substitutes for Forzinity. Updated 2026-06-04.
Goals
Goal-based dosing.
Barth Syndrome Muscle Strength
Dose: 40 mg subcutaneously once daily for patients weighing at least 30 kg3
Timing: Daily per label
FDA accelerated approval; specialist monitoring required.
Primary Mitochondrial Myopathy
Dose: No approved dose for this indication1,2
Timing: Study protocol only
Phase 3 trial did not meet primary endpoints.
Longevity or Fatigue Wellness
Dose: No approved dose1
Timing: Not applicable
Off-label wellness benefit is not established.
Lab work
Markers to track.
What to test, the optimal window inside the conventional range, and how long a response takes.
Lactate
May be followed in mitochondrial disease care but is not a direct response marker for all patients.1,2
Optimal
0.5–2 mmol/L
Conventional
0.5–2.2 mmol/L
Responds in
Baseline and per specialist plan
0.5optimal2.2
Interpret with symptoms, genetics, and exercise testing.
Creatine kinaseAcylcarnitine profile
Creatine Kinase CK
May help assess muscle injury but is not specific to elamipretide response.3
Optimal
40–170 U/L
Conventional
40–200 U/L
Responds in
As clinically indicated
40optimal200
Recent exercise can raise CK.
LactateASTALT
Why people use it
Symptoms it's matched to.
Where this appears in the symptom-to-supplement map, ranked by relevance.
Muscle weakness
28% relevance
FDA approval is for improving muscle strength in Barth syndrome patients meeting label criteria.3
MusculoskeletalModerate evidenceForzinity under specialist care
Not for nonspecific weakness without diagnosis.
Exercise intolerance
16% relevance
Mitochondrial disease trials are relevant, but PMM phase 3 endpoints were not met.1,2
EnergyEmerging evidenceSpecialist-directed only
Evaluate cardiopulmonary and mitochondrial causes.
Mitochondrial disease fatigue
12% relevance
Mechanism is mitochondrial, but benefit is diagnosis-specific.1,2
EnergyEmerging evidenceSpecialist-directed only
Avoid research products.
Safety
Full safety detail.
Side effects
- Injection-site pain
- Injection-site erythema or pruritus
- Nausea
- Headache
- Dizziness
- Hypersensitivity reaction
- Unknown long-term off-label safety
Contraindications
- Use outside FDA-approved Barth syndrome indication without specialist oversight3
- Known hypersensitivity to elamipretide or excipients1,2
- Pregnancy and breastfeeding without specialist review
- Research-grade or compounded products substituted for Forzinity
- Mitochondrial symptoms without diagnostic evaluation1,2
Interactions
Interaction records.
InfoCaution
Creatine
Creatine may affect muscle performance metrics and complicate interpretation of treatment response.
Recommendation: Keep supplement use stable during monitored strength testing.
ModerateCaution
Alpha-Lipoic Acid
Alpha-lipoic acid can lower glucose and is used for mitochondrial redox claims, complicating adverse-effect attribution.
Recommendation: Use only with clinician awareness in mitochondrial protocols.
Sources
Sources, by evidence tier.
Numbered references. Citations throughout the page link here.
Randomized controlled trials
2- 1Efficacy and Safety of Elamipretide in Individuals With Primary Mitochondrial Myopathy: The MMPOWER-3 Randomized Clinical TrialNeeds sourceNo linkKaraa A et al. · Neurology · 2023
Primary endpoints were not met
- 2A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathyNeeds sourceNo linkKaraa A et al. · Journal of Cachexia, Sarcopenia and Muscle · 2020
Short-term crossover data suggested signals
Reference material
1- 3Drug Trials Snapshots: ForzinityNeeds sourceNo linkUS Food and Drug Administration · FDA Drug Trials Snapshots · 2025
Approved September 19, 2025 under accelerated approval; the initial randomized portion did not show superiority on primary endpoints.
Keep exploring
Deep dives & adjacent profiles.
This page is educational. Do not start, stop, or change a supplement or medication based on it without checking with a qualified healthcare professional.
Use this with your stack
Elamipretide (SS-31) in NutriStack.
Add it to your stack, see how it interacts with everything else you take, and get a Stack Score that updates the moment it does.