Research Library / Mitochondrial / Elamipretide
Mitochondrial researchElamipretide (SS-31)
SS-31 · Bendavia · FORZINITY
A mitochondrial cardiolipin binder. The listed community example (reported daily research range) describes 4–40 mg per administration, once daily, via subcutaneous; this is not a validated dosing recommendation. An illustrative 10 mg vial at an assumed 1 mL final volume yields 10 mg/mL; diluent compatibility remains product-specific. For research and education only, not personal medical guidance.
Quick Reference
- Example vial
- 10mg
- Assumed final volume
- 1mL · not an amount to add
- Concentration
- 10mg/mL · conditional arithmetic
- One U-100 marking
- 100mcg in 0.01 mL
Hypothetical vial math does not reproduce a study formulation or verify a diluent, sterility or storage period.
Research schedules
40 mg · subcutaneous · once daily at the same time; adults with eGFR below 30 mL/minute not on dialysis: 20 mg daily. Insufficient dosing information for dialysis or pediatric renal impairment. Ready-to-use 280 mg/3.5 mL (80 mg/mL) solution; no reconstitution.
Adults and pediatric patients with Barth syndrome weighing at least 30 kgFDA prescribing information, September 2025Subcutaneous and intravenous regimens vary by indication
Other mitochondrial and cardiac-disease populations; not approved indicationsClinicalTrials.govReported schedule context
- Range
- 4–40 mg/day
- Frequency
- Daily
- Route
- Subcutaneous
- Reported half-life
- ~2–4 hours
- Reported cycle
- Study-dependent
This range describes community reports, not FORZINITY labeling. The approved ready-to-use Barth-syndrome product has separate clinical instructions; research powder is not interchangeable.
Cross-reference reviewed October 2026. Half-life and cycles retain this source context.| Context / phase | Amount | Schedule total | Frequency | Timing | Route | Evidence |
|---|---|---|---|---|---|---|
| Reported daily research range | 4–40 mg | 4–40 mg/day | Once daily | Consistent daily time | Subcutaneous | Community-reported |
Repeated community reports do not establish identity, safety, effectiveness or an appropriate exposure. Component schedules do not validate a same-vial blend.
Vial calculator
Linked to Quick Reference and compatible supply calculations.
Read the needle-side edge of the black stopper. Liquid tint is illustrative.
Scale illustration · one U-100 marking = 0.01 mL.
Arithmetic yield at this example amount
2 example portions per vial
2 full amounts; 0 mg remaining. Yield is not a storage or reuse period.
See the calculation
Concentration = vial content ÷ final volume. Volume = example amount ÷ concentration. U-100 markings = mL × 100.
Original example & formulation context
5 mg · 10 mg/mL · 0.5 mL · 50 units
FORZINITY is a ready-to-use elamipretide solution containing phosphate and benzyl alcohol. It does not require reconstitution and is distinct from a generic 10 mg SS-31 powder. The calculation assumes the stated final solution volume, which may differ from liquid added. It does not verify dissolution, solvent compatibility, sterility, chemical stability or storage. See the source-linked preparation notes below.
Supplies & vial yield
10 mg (hypothetical) · 1 mL assumed final solution volume; diluent product-specific · Reported daily research range
Vial counts and final solution totals below use the selected 10 mg example at 1 mL. The original schedule totals stay unchanged.
Schedule phases used for planning
| Phase | Amount | Frequency | Weekly total |
|---|---|---|---|
| Selected planning schedule | 4–40 mg | Once daily | 28–280 mg/week |
Peptide vials
| Horizon | Total | Vials* |
|---|---|---|
| 4 weeks | 112–1120 mg | 12–112 × 10 mg |
| 8 weeks | 224–2240 mg | 23–224 × 10 mg |
| 12 weeks | 336–3360 mg | 34–336 × 10 mg |
Liquid planning
| Horizon | Final volume* | Diluent supplies |
|---|---|---|
| 4 weeks | 12–112 mL | Not established |
| 8 weeks | 23–224 mL | Not established |
| 12 weeks | 34–336 mL | Not established |
Administration count
| Horizon | Administrations |
|---|---|
| 4 weeks | 28 |
| 8 weeks | 56 |
| 12 weeks | 84 |
Original schedule counts. Check the calculated volume against syringe capacity; no split-dose technique is assigned.
Original vial-life context
4 weeks: 0.25–2.5 administrations
8 weeks: 0.25–2.5 administrations
12 weeks: 0.25–2.5 administrations
Applies to the original planning basis above; not a product stability period.
Ranges reflect the low and high ends of the selected displayed schedule (community-reported). Vials are rounded up; one new U-100 syringe is counted per subcutaneous administration. Liquid totals are conditional final solution volumes, not verified quantities to add. Diluent bottle counts are withheld pending product-specific preparation instructions. Arithmetic does not establish storage or reuse periods.
*Conditional mass and final-volume arithmetic. No stability, sterility, safe reuse period or verified diluent quantity is established. Cleansing materials, sterile supplies, labels and sharps disposal follow the actual research procedure.
Protocol overview & research context
- Identity
- Elamipretide · SS-31 · Bendavia · FORZINITY
- Evidence / status
- FDA accelerated approval. FDA accelerated approval September 19, 2025 for muscle strength in Barth syndrome, age groups weighing at least 30 kg; other uses investigational
- Clinical route, frequency & duration
FORZINITY approved-product label: 40 mg · subcutaneous · once daily at the same time; adults with eGFR below 30 mL/minute not on dialysis: 20 mg daily. Insufficient dosing information for dialysis or pediatric renal impairment. Ready-to-use 280 mg/3.5 mL (80 mg/mL) solution; no reconstitution.
Other clinical development: Subcutaneous and intravenous regimens vary by indication
- Community purpose
- Mitochondrial function, cellular energy, fatigue, and healthy-aging research.
- Reported timing / route
- Daily · Subcutaneous. Schedule-specific timing remains in the Community tab.
- Reported half-life
- ~2–4 hours · community-reference context, not a shelf life.
- Reported cycle
- Study-dependent. Planning horizons do not establish a validated cycle.
Loading, titration and maintenance
A separate loading phase is not identified in this library entry. Titration, maintenance and stopping rules depend on the specific product or study; a listed range is not automatically an escalation plan.
Reconstitution & formulation
FORZINITY is a ready-to-use elamipretide solution containing phosphate and benzyl alcohol. It does not require reconstitution and is distinct from a generic 10 mg SS-31 powder.
Other vehicles and approaches discussed
Community guides discuss saline, PBS and BAC-water powder preparations, but these do not reproduce the approved formulation or establish comparative compatibility or shelf life.
- Evidence context
- Product / laboratory / report distinctions apply
- Cloudiness / gel signal
- Finished product versus research powder
- Product details to verify
- Verify the exact product, sequence/salt form, buffer and excipients, concentration, route, container and product-specific storage instructions.
Sources apply to the named product, laboratory method or report only. Laboratory solvents and community repetition do not establish an injectable preparation, sterility, chemical stability or a beyond-use period. No solvent-mixing or salvage recipe is provided.
Preparation references reviewed October 20, 2026.
Preparation documentation checklist
- Confirm identity, nominal content, salt form, buffer and excipients.
- Verify the actual product's diluent, amount to add and intended method.
- Calculate concentration from final solution volume, and cross-check units.
- Record lot, concentration, diluent, preparation date, storage and discard instructions.
This checklist does not replace a validated preparation procedure.
Storage, clarity & stability
- Unopened product
- Follow its documented temperature, light protection, shipping and expiration requirements.
- Prepared material
- Chemical stability and microbial safety are formulation-specific. A diluent bottle's discard period does not establish the compound's storage period.
- Visible-change context
- Finished product versus research powder
Unexpected cloudiness, particles or gel
For a product intended to form a clear solution, do not use or attempt to salvage unexpected persistent clouding, strings, precipitate, thickening or gel. Labeled suspensions, including some triptorelin depots, have their own expected appearance and instructions.
Why vial yield does not establish shelf life
Arithmetic portions assume the material remains usable. Chemical degradation, contamination, handling losses and required discard limits may reduce practical yield. Freezing, warming, acidifying or further diluting cannot be assumed to restore quality.
No universal refrigerated, room-temperature or 90-day beyond-use period is assigned by the calculator.
How it works
Mitochondria-targeting cardiolipin-interacting tetrapeptide
A mitochondrial cardiolipin binder. FORZINITY has indication-specific accelerated approval for Barth syndrome; research-use SS-31 powders are not the approved product.
Community-reported purpose
Mitochondrial function, cellular energy, fatigue, and healthy-aging research.
Reported purposes and marketing use-cases are not an approved indication or proof of efficacy.
Clinical findings & study landscape
FORZINITY approved-product label
Protocol: 40 mg · subcutaneous · once daily at the same time; adults with eGFR below 30 mL/minute not on dialysis: 20 mg daily. Insufficient dosing information for dialysis or pediatric renal impairment. Ready-to-use 280 mg/3.5 mL (80 mg/mL) solution; no reconstitution.
Population: Adults and pediatric patients with Barth syndrome weighing at least 30 kg
Read the cited evidenceOther clinical development
Protocol: Subcutaneous and intravenous regimens vary by indication
Population: Other mitochondrial and cardiac-disease populations; not approved indications
Read the cited evidenceFindings apply to the tested product, population and methods. A registry listing, mechanistic study or evidence-landscape link is not itself proof of efficacy or validation of an online vial.
Safety, evidence limits & regulatory status
Compound-specific safety context
Injection-site reactions and hypersensitivity require attention. Contains benzyl alcohol; not for neonates. Accelerated approval requires confirmation of clinical benefit. The label does not validate generic research powders or anti-aging use.
Development and regulatory status
FDA accelerated approval September 19, 2025 for muscle strength in Barth syndrome, age groups weighing at least 30 kg; other uses investigational
Approval of a named product does not extend to every vial, formulation, route, blend or indication carrying a related name.
What this guide cannot establish
The library does not authenticate a product or determine a personal starting dose, missed-dose rule, restart regimen, interaction plan or combination protocol. Study schedules, community reports and vial calculations retain separate evidence labels.
Frequently asked questions
What is Elamipretide?
A mitochondrial cardiolipin binder. FORZINITY has indication-specific accelerated approval for Barth syndrome; research-use SS-31 powders are not the approved product.
Mitochondria-targeting cardiolipin-interacting tetrapeptide
Does vial strength mean the amount per administration?
No. A vial's label states nominal contents. The amount used in a study belongs to its assigned product and protocol. Changing vial strength changes concentration and yield, not the study's assigned amount.
Why does changing final volume change the U-100 value?
A larger final volume reduces concentration for the same mass. U-100 markings are volume measurements: one marking equals 0.01 mL. They are not biological international units of a peptide.
What happens when a calculation exceeds one syringe or vial?
Available mass and syringe capacity are separate limits. The calculator flags a result above 1 mL; it does not provide a splitting or combining technique.
Is there a loading phase or standard cycle?
A separate loading phase is not identified in this entry. Do not infer one from a range of reported amounts.
Study-dependent
Which diluent and storage period should this material use?
FORZINITY is a ready-to-use elamipretide solution containing phosphate and benzyl alcohol. It does not require reconstitution and is distinct from a generic 10 mg SS-31 powder.
Calculation examples do not establish solvent compatibility, sterility or shelf life.
Where do I track or calculate a multi-phase schedule?
The Free Planner supports saved research examples and multi-phase planning. This guide's calculator is local to the page and does not save a protocol automatically.
Open Free PlannerReferences & evidence trail
- Clinical / regulatory / evidence landscapeFDA prescribing information, September 2025: FORZINITY approved-product label
- Clinical / regulatory / evidence landscapeClinicalTrials.gov: Other clinical development
- Product labelFORZINITY prescribing information
- Community/vendor report — unvalidatedSS-31 community preparation guide
Clinical sources remain attached to their studies; laboratory and community formulation sources retain their own limits. Preparation review dates do not imply that every clinical study was newly reviewed today.
Independent educational research reference. Not medical advice or an individualized dosing recommendation.