Mito Stack

elamipretide: drug concentration in plasma (ng/mL).

Published fixed-parameter elamipretide model with the reported absorption delay.

Fixed reference profile: Fixed tabulated SPICP-105 parameters from 41 healthy participants; no particular reference age or weight is asserted. Elamipretide hydrochloride solution, 40 mg active moiety in 0.5 mL in the source comparator.; Subcutaneous abdomen.

Changing dose or schedule explores a scenario; it does not personalize the reference profile or establish a studied regimen.

Input dose basis: Milligrams of active elamipretide. The 40 mg active dose corresponds to 46.8 mg hydrochloride salt; enter active mass only.

Source exposure scope: Same-product comparator: a single 40 mg active elamipretide hydrochloride-formulation injection into the abdomen. Other doses and repeated schedules are model scenarios.

Elamipretide fixed source model

elamipretide-fda-2025-spicp105 · version 1

• Applicant SPICP-105 column in FDA Table 129; covariate multipliers fixed at one and no random effects. This is not a claimed population-average or personalized curve.
• The 2.63-minute absorption delay is included. No acetate or thigh-injection adjustment is applied.
• CL/F,Vc/F,Q/F,Vp/F are apparent; do NOT multiply by label92%F. No acetate1.05 or thigh0.957 factor for HCl/abdomen reference.

Model structure

Two compartments with absorption

Apparent clearance (CL/F)

10.04167 L/hour

Apparent central volume (Vc/F)

1.96 L

Absorption rate (ka)

0.5541667 /hour

Absorption delay

0.04383333 hours

Apparent intercompartmental clearance (Q/F)

1.895833 L/hour

Apparent peripheral volume (Vp/F)

8.89 L

Input mass conversion

1 mg modelled mass per mg entered

• Fixed tabulated typical values are used without person-specific covariates. The inspected table does not expose the centering age/weight; do not label this as a 70 kg person.
• Different formulation/site and population exposure summaries must not be pooled as one cohort.
• Requires implementing the reported absorption lag for faithful timing.
• Table 129 covariate continuation lists acetate 1.05,thigh 0.957,age 0.994 andweight 0.995 effects onKa, fixed weight allometry; tabulated values are used only without individual adjustments, not a personalized model.
• The source-model 40 mg peak is about 1470 ng/mL and AUC 3983 ng·h/mL; separate same-product observed geometric means were 1440 and 3950. Similarity does not make these identical study statistics.
• Only parent elamipretide is modeled; the M1 and M2 metabolites are excluded.

• FDA Forzinity integrated review — Tables 124 and 129

  Table 129 applicant SPICP-105 column: CL/F 241 L/day, Vc/F 1.96 L, Q/F 45.5 L/day, Vp/F 8.89 L, Ka 13.3/day and 2.63-minute lag. Table 124 gives the separate 40 mg HCl/abdomen comparator.

• Forzinity prescribing information — active mass and formulation

  Section 11 distinguishes 40 mg active elamipretide from 46.8 mg hydrochloride salt. The label is not the source of Table 129 model coefficients.

Legacy 12 h has no administered-human timing support in reviewed sources.

One 1 mg input peaks at 1 relative unit after a single dose. Other amounts scale proportionally; overlapping doses add when accumulation is on. Different compounds use separate relative scales.

Timing half-life used

12 hours

Absorption half-life assumed

3 hours

Reference amount for the relative scale

1 mg

• Absorption half-life is assumed to be one quarter of the slower timescale (3 h); it is not a measured absorption parameter.
• A single 1-unit input has a peak of 1 relative unit; scaling and repeated-dose addition are mathematical assumptions. This normalization is independent of the example dose.
• Do not substitute the modified analog CB4211 or engineered R13A-MOTS-c for native MOTS-c.
• Endogenous biomarker concentrations cannot calibrate an entered exogenous dose.

• MOTS-c is an exercise-induced mitochondrial-encoded regulator of age-dependent physical decline and muscle homeostasis.

  Legacy 12 h has no administered-human timing support in reviewed sources.

mots-c-relative-timing-2026-10 · version 1