Drug companion protocol
Forzinity
Active ingredient: Elamipretide
A mitochondria-targeted tetrapeptide, also known as elamipretide, approved in the U.S. as Forzinity for a narrow Barth syndrome indication.
Quickstart Highlights
- Drug class
- Mitochondrial cardiolipin binder
- Route
- Subcutaneous injection
- Schedule
- FDA-approved Forzinity is once-daily subcutaneous elamipretide for Barth syndrome patients weighing at least 30 kg; the 10 mg vial page is an editorial research protocol and not the Forzinity label
- Evidence score
- 62
Quickstart highlights
- 💉Subcutaneous injection
- 🔬Mitochondrial cardiolipin binder
- 🧪Lyophilised powder — requires reconstitution with bacteriostatic water
- 📋Prescription required
How this works
Mechanism of action and pharmacokinetic profile from published data.
SS-31 / elamipretide is a mitochondria-targeted tetrapeptide that binds cardiolipin in the inner mitochondrial membrane. It is intended to stabilize mitochondrial bioenergetics and reduce oxidative stress in selected disease contexts.
- Time to peak (Tmax)
- Refer to approved label for Forzinity PK details.
- Clearance
- Refer to approved label for renal impairment and other clinical considerations.
- Elimination half-life
- The FDA label should be used for approved Forzinity pharmacokinetics; editorial 10 mg vial protocols are not label-equivalent.
- Bioavailability
- Forzinity is administered subcutaneously; research lyophilized SS-31 protocols are separate from the approved product.
Dosing & Reconstitution Guide
Full preparation, protocol, and administration reference for compounded lyophilised formulations.
Protocol overview
FDA-approved Forzinity is once-daily subcutaneous elamipretide for Barth syndrome patients weighing at least 30 kg; the 10 mg vial page is an editorial research protocol and not the Forzinity label.
Dose escalation phases
Editorial SS-31 10 mg vial advanced reference
| Phase | Dose | Frequency | Guidance |
|---|---|---|---|
| Weeks 5-8 split injection Week 5-8 | 15 mg | daily split injections | Editorial advanced research reference. Advanced editorial dosing is not a prescribing protocol; use medical supervision for any approved elamipretide use. |
| Optional weeks 9-12 split injection Week 9-12 | 20 mg | daily split injections | Editorial optional advanced research reference. Advanced editorial dosing is not a prescribing protocol and is not the Forzinity label. |
Editorial SS-31 10 mg vial standard reference
| Phase | Dose | Frequency | Guidance |
|---|---|---|---|
| Weeks 1-2 Week 1-2 | 5 mg | once daily | Editorial starter reference. Not the Forzinity label. Do not treat as approved dosing. |
| Weeks 3-8 Week 3-8 | 10 mg | once daily | Editorial standard reference. Not the Forzinity label. Do not treat as approved dosing. |
Forzinity approved label reference
| Phase | Dose | Frequency | Guidance |
|---|---|---|---|
| Daily labeled dose Week 0+ | 40 mg | once daily | FDA-approved Barth syndrome label reference for patients weighing at least 30 kg. Use the FDA label and prescriber instructions; reduce dose in severe renal impairment per label. |
Supplies needed
- ◦Research vial or approved Forzinity product — Do not interchange the editorial 10 mg lyophilized SS-31 vial instructions with the FDA-approved Forzinity ready-to-use vial label.
10 mg vial — dosing tables
Editorial 10 mg vial standard protocol (10 mg/mL)
| Phase / Dose | U-100 Units | Volume (mL) |
|---|---|---|
| Weeks 1-2 | 50 | 0.50 |
| Weeks 3-8 | 100 | 1.00 |
Editorial 10 mg vial advanced protocol (10 mg/mL)
| Phase / Dose | U-100 Units | Volume (mL) |
|---|---|---|
| Weeks 1-2 | 50 | 0.50 |
| Weeks 3-4 | 100 | 1.00 |
| Weeks 5-8 split injection reference | 150 | 1.50 |
| Optional weeks 9-12 split injection reference | 200 | 2.00 |
30 mg vial — dosing tables
Editorial 30 mg vial standard protocol (10 mg/mL)
| Phase / Dose | U-100 Units | Volume (mL) |
|---|---|---|
| Weeks 1-2 | 50 | 0.50 |
| Weeks 3-8 | 100 | 1.00 |
Editorial 30 mg vial advanced protocol (10 mg/mL)
| Phase / Dose | U-100 Units | Volume (mL) |
|---|---|---|
| Weeks 1-2 | 50 | 0.50 |
| Weeks 3-4 | 100 | 1.00 |
| Weeks 5-8 split injection reference | 150 | 1.50 |
| Optional weeks 9-12 split injection reference | 200 | 2.00 |
50 mg vial — dosing tables
Editorial 50 mg vial standard protocol (16.67 mg/mL)
| Phase / Dose | U-100 Units | Volume (mL) |
|---|---|---|
| Weeks 1-2 | 30 | 0.30 |
| Weeks 3-8 | 60 | 0.60 |
Editorial 50 mg vial advanced protocol (16.67 mg/mL)
| Phase / Dose | U-100 Units | Volume (mL) |
|---|---|---|
| Weeks 1-2 | 30 | 0.30 |
| Weeks 3-4 | 60 | 0.60 |
| Weeks 5-8 | 90 | 0.90 |
| Optional weeks 9-12 split injection reference (2 x 60 units) | 120 | 1.20 |
Reconstitution steps
Vial size
10 mg
BAC water to add
1 mL
Resulting concentration
10 mg/mL
At 10 mg/mL, 1 U-100 unit = 0.01 mL = 0.1 mg (100 mcg). This applies to the editorial 10 mg research-vial protocol, not the ready-to-use Forzinity vial.
Editorial research-vial protocol: add 1.0 mL bacteriostatic water slowly down the vial wall, avoid vigorous shaking, gently swirl or roll until clear, label with reconstitution date, protect from light, and refrigerate.
Vial size
30 mg
BAC water to add
3 mL
Resulting concentration
10 mg/mL
At 10 mg/mL, 1 U-100 unit = 0.01 mL = 0.1 mg (100 mcg). This matches the 10 mg vial concentration, but the vial contains more total doses.
Editorial 30 mg vial protocol: add 3.0 mL bacteriostatic water slowly down the vial wall, avoid vigorous shaking, gently swirl or roll until clear, label with reconstitution date, protect from light, and refrigerate.
Vial size
50 mg
BAC water to add
3 mL
Resulting concentration
16.67 mg/mL
At about 16.67 mg/mL, 1 U-100 unit = 0.01 mL = about 0.167 mg (167 mcg). This changes the units for the same mg dose versus 10 mg/mL vials.
Editorial 50 mg vial protocol: add 3.0 mL bacteriostatic water slowly down the vial wall, avoid vigorous shaking, gently swirl or roll until clear, label with reconstitution date, protect from light, and refrigerate.
Injection steps
- 1Follow the applicable product instructions
For approved Forzinity use, follow the FDA label and prescriber training. For a research vial, use the applicable research protocol.
Storage instructions
Before reconstitution
Editorial protocol describes frozen lyophilized storage around -20 C, protected from light and moisture.
After reconstitution
Refrigerate reconstituted solution at 2-8 C and protect from light.
Editorial page describes use within 4 weeks.
Important notes
- !Label distinction
Forzinity label dosing, storage, and safety instructions supersede editorial research-vial protocol pages when the approved product is used.
Concentration calculations are standard compounding arithmetic. Protocol phases are drawn from published Phase 2 trial data. Your prescriber and dispensing pharmacy determine the actual dose, vial size, and escalation schedule for your treatment.
Your journey
Where you are in a typical protocol, and what one dose cycle looks like. Educational — your prescriber tailors the plan to you.
Protocol timeline
Starter reference
Weeks 1–25 mgevery 1dWhat to expect: editorial research-vial start
Focus on: site rotation, do not treat as approved dosing
Common adjustments: not equivalent to Forzinity label
Standard reference
Weeks 3–810 mgevery 1dWhat to expect: editorial 10 mg/day reference
Focus on: monitor injection-site reactions, avoid unsupported use claims
Common adjustments: not equivalent to Forzinity label
Advanced split-dose reference
Weeks 5–1215 mgevery 1dWhat to expect: editorial 15-20 mg/day split-injection reference
Focus on: split injection sites, monitor adverse reactions
Common adjustments: medical supervision emphasized by source
Approved Barth syndrome label reference
Weeks 0+40 mgevery 1dWhat to expect: FDA-approved indication-specific daily dose
Focus on: use approved product labeling, monitor hypersensitivity
Common adjustments: renal impairment dose reduction per label
Daily companion
Practical playbooks for managing symptoms, eating around side effects, tracking what matters, and reporting back to your clinician.
Food guidance by situation
Prefer: site rotation, steady hydration
Limit: reusing injection sites
Avoid: confusing research-vial instructions with Forzinity labeling
The approved Forzinity label and editorial SS-31 vial protocol both emphasize subcutaneous administration and site considerations.
What to track
Suggested check-in cadence: daily.
Injection-site reaction
scale 0 10
Energy
scale 0 10
Sleep quality
scale 0 10
Unexpected symptoms
text
Safety and interactions
Share this information with your prescriber for personalised care decisions.
Red-flag symptoms — seek urgent care
- Hypersensitivity symptomsUrgent careSeek urgent care for breathing difficulty, swelling, widespread rash, or serious allergic symptoms during elamipretide exposure.
- Hypersensitivity symptoms. Serious allergic symptoms such as breathing difficulty, widespread rash, swelling, or severe skin reaction need urgent medical assessment.
Structured warnings
Approved label differs from research-vial protocol
Forzinity is the FDA-approved elamipretide product for a narrow Barth syndrome indication. The 10 mg vial SS-31 protocol page is an editorial research protocol and is not the Forzinity label.
Benzyl alcohol and hypersensitivity label warnings
Forzinity labeling warns about benzyl alcohol toxicity in neonates and serious hypersensitivity reactions. Use the approved label for Forzinity-specific safety decisions.
Hypersensitivity symptoms
Serious allergic symptoms such as breathing difficulty, widespread rash, swelling, or severe skin reaction need urgent medical assessment.
Indication and approval status
Improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.
Adult and pediatric Barth syndrome patients weighing at least 30 kg, per Forzinity label.
Other mitochondrial, metabolic, or longevity uses are not represented as approved indications here.
Clinical trial or prescriber-directed contexts only.
Who should not take this
Forzinity is contraindicated in people with serious hypersensitivity to elamipretide or excipients. It is not approved for neonates because the formulation contains benzyl alcohol. Research-vial SS-31 protocols are not equivalent to the FDA-approved Forzinity product label.
Missed-dose guidance
If a Forzinity dose is missed, skip it and take the next dose at the scheduled time.
Do not take a double dose of Forzinity.
No approved missed-dose rule exists for the editorial 10 mg SS-31 research-vial protocol.
Do not double doses based on an editorial schedule; use the approved Forzinity label or prescriber instructions when applicable.
When to seek help
Severe, persistent, spreading, or infected-appearing injection-site reaction.
Contact the prescriber; urgent care if systemic allergic symptoms occur.
Breathing difficulty, swelling, widespread rash, or serious allergic symptoms.
Seek urgent medical care and do not rechallenge without medical direction.
Approved injection sites
Abdomen
For Forzinity, rotate daily and use abdomen at least 2 inches from the navel; editorial SS-31 protocol also describes site rotation.
Avoid: Do not inject where skin is tender, bruised, red, hard, scarred, or stretch-marked.
Thigh
For Forzinity, outer thigh is an approved site; rotate injection site daily.
Avoid: Avoid tender, bruised, red, hard, scarred, or stretch-marked skin.
Structured storage
Forzinity ready-to-use vial
after first opening
Use label storage instructions
Discard vials 8 days after first opening per label.
Ready-to-use Forzinity is not the same as a lyophilized 10 mg research vial.
research lyophilized vial
before reconstitution
-20 C
Editorial protocol says store frozen, sealed, dry, and protected from light.
research reconstituted vial
after reconstitution
2-8 C
Editorial page describes 4 weeks.
Not the approved Forzinity storage label.
Storage and handling
FDA-approved Forzinity is a ready-to-use solution with label-specific storage and discard instructions. Lyophilized 10 mg SS-31 vial handling from editorial protocol pages should not be treated as the approved product label.
Research evidence
Published studies, labels, regulator pages, and curated protocol sources connected to this profile.
API source references
SS-31 10 mg vial PeptideDosages protocol
Editorial research protocol page for SS-31 10 mg vial; not the FDA-approved Forzinity label.
Open source ↗Forzinity prescribing information
FDA prescribing information for Forzinity (elamipretide) injection, initial U.S. approval 2025.
Open source ↗SS-31 30 mg vial PeptideDosages protocol
Editorial research protocol page for SS-31 30 mg vial; not the FDA-approved Forzinity label.
Open source ↗SS-31 50 mg vial PeptideDosages protocol
Editorial research protocol page for SS-31 50 mg vial; not the FDA-approved Forzinity label.
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