Meta Information
ID:ss-31
Name:
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-05-21T22:30:00Z
Model
phase-a-upgrade-claude-sonnet-4.6
Interactions
Target id:
/condition/renal-impairment
Target name:
Renal Impairment
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
SS-31 is cleared from the body by the kidneys. Impaired kidney function can cause the peptide to accumulate to potentially toxic levels, increasing the risk of adverse effects.
Actionable advice:
This should be used only under strict medical supervision, with potential dose adjustments, in those with any degree of kidney disease.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
The FORZINITY dose should be reduced by one half administered subcutaneously once daily in adults with severe renal impairment (eGFR less than 30 mL/min) who are not on dialysis
Label source:
FDA label: Elamipretide (Forzinity)
Action type:
adjust_with_prescriber
Target id:
/class/nephrotoxic-agents
Target name:
Nephrotoxic Agents (NSAIDs, ACEi, ARBs)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Concurrent use of SS-31 with other drugs known to be potentially harmful to the kidneys (like high-dose NSAIDs or certain antibiotics) can compound the risk of renal injury. [class-derived from: class_pharmacology]
Actionable advice:
Other kidney-toxic drugs should not be used simultaneously unless medically necessary and closely monitored by a physician.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Exact phrase from label:
Elamipretide exposure (AUC) increased by 39% in subjects with creatinine clearance 60 to 89 mL/min, 75% in subjects with creatinine clearance 30 to 59 mL/min, and 125% in subjects with creatinine clearance less than 30 mL/min not on dialysis
Label source:
FDA label: Elamipretide (Forzinity) [class-derived for nephrotoxic-agents]
Action type:
avoid
Target id:
/condition/pregnancy
Target name:
Pregnancy
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
The safety of SS-31 during human pregnancy has not been established. The potential risks to a developing fetus are unknown.
Actionable advice:
This should be strictly avoided during pregnancy or when planning to become pregnant.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
there are no data with FORZINITY use in pregnant women to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
Label source:
FDA label: Elamipretide (Forzinity)
Action type:
avoid
Target id:
/condition/lactation
Target name:
Breastfeeding (Lactation)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
It is not known if SS-31 passes into breast milk or what its effects might be on a nursing infant.
Actionable advice:
It should be avoided completely while breastfeeding.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
there is no data to evaluate the presence of FORZINITY in human milk, the effect on the breastfed infant, or the effects on milk production
Label source:
FDA label: Elamipretide (Forzinity)
Action type:
avoid
Target id:
/biomarker/advanced-renal-function-panel
Target name:
Advanced Renal Function Panel (eGFR, Creatinine, Cystatin C)
Severity:
major
Interaction type:
requirement
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Due to its renal clearance pathway, regular monitoring of kidney function is a critical safety requirement to ensure the drug is being cleared properly and not accumulating.
Actionable advice:
Obtain baseline and periodic kidney function tests (e.g., eGFR, creatinine) before and during SS-31 therapy.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
Elamipretide exposure (AUC) increased by 39% in subjects with creatinine clearance 60 to 89 mL/min, 75% in subjects with creatinine clearance 30 to 59 mL/min, and 125% in subjects with creatinine clearance less than 30 mL/min not on dialysis
Label source:
FDA label: Elamipretide (Forzinity)
Action type:
monitor
Target id:
/intervention/coenzyme-q10
Target name:
Coenzyme Q10 (CoQ10)
Severity:
minor
Interaction type:
synergistic
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
CoQ10 is an essential component of the electron transport chain for ATP production. Its role may complement SS-31's action of stabilizing the mitochondrial membrane where this process occurs.
Actionable advice:
Consider taking concurrently, as it may provide additive support for mitochondrial energy production.
Validation status:
validated_via_primary_literature
Evidence tier:
tier_b
Evidence basis:
primary_literature_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
CoQ10 is essential for the production of energy and also has antioxidative properties.
Label source:
PubMed: Evidence of plasma CoQ10-lowering effect by HMG-CoA reductase inhibitors: a double-blind, placebo-controlled study. (PMID 8463436)
Action type:
informational_none
Target id:
/intervention/l-carnitine
Target name:
L-Carnitine
Severity:
minor
Interaction type:
synergistic
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
L-Carnitine facilitates the transport of fatty acids into the mitochondria for beta-oxidation. This may synergize with SS-31 by providing fuel for the energy production machinery that SS-31 helps to stabilize.
Actionable advice:
Consider taking concurrently for potentially enhanced support of mitochondrial metabolism.
Validation status:
validated_via_primary_literature
Evidence tier:
tier_b
Evidence basis:
primary_literature_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Acylcarnitines (ACs) play a pivotal role in metabolism, most notably by facilitating the transport of fatty acids (FAs) into mitochondria for β-oxidation, a key step in cellular energy production.
Label source:
PubMed: Simultaneous determination of acylcarnitines, fatty acids, and amino acids by 3-nitrophenylhydrazine derivatization and ultra-high performance liquid chromatography/tandem mass spectrometry. (PMID 42166804)
Action type:
informational_none
Target id:
/intervention/alpha-lipoic-acid
Target name:
Alpha-Lipoic Acid (ALA)
Severity:
minor
Interaction type:
synergistic
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
ALA is a potent mitochondrial antioxidant. This action may complement SS-31's ability to reduce mitochondrial reactive oxygen species (ROS) production, offering dual protection against oxidative stress.
Actionable advice:
Consider taking concurrently to potentially enhance mitochondrial antioxidant defenses.
Validation status:
validated_via_pubmed
Evidence tier:
tier_b
Evidence basis:
pubmed_abstract_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Therapeutic strategies for mitochondrial diseases include the use of agents enhancing electron transfer chain function (coenzyme Q10, idebenone, riboflavin, dichloroacetate, and thiamine), agents acting as energy buffer (creatine), antioxidants (vitamin C, vitamin E, lipoic acid, cysteine donors, and EPI-743), amino acids restoring nitric oxide production (arginine and citrulline), cardiolipin protector (elamipretide), agents enhancing mitochondrial biogenesis (bezafibrate, epicatechin, and RTA 408), nucleotide bypass therapy, liver transplantation, and gene therapy.
Label source:
PubMed: Molecular genetics and metabolism (2017)
Source url:
Exact phrase from label:
SS-31 is a mitochondria-targeting peptide that has been used in the treatment of many diseases by scavenging ROS and ameliorating mitochondrial function.
Label source:
PubMed: Free radical research (2021)
Source url:
Exact phrase from label:
We observed increased mitochondrial ROS production that was restored by SS-31 treatment.
Label source:
PubMed: Scientific reports (2018)
Action type:
informational_none
Target id:
/circadian/wake
Target name:
Waking Up
Severity:
minor
Interaction type:
synergistic
Nature:
temporal
Temporal spacing:
Hours before target:
null
Hours after target:
1
Description:
Mitochondrial activity follows a circadian rhythm, with higher energy demands in the morning. Administering SS-31 upon waking may align its effects with the body's natural metabolic cycle.
Actionable advice:
Administer in the morning, within an hour of waking, for potential alignment with circadian bioenergetics.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Exact phrase from label:
Patients should receive the dose at the same time each day
Label source:
FDA label: Elamipretide (Forzinity)
Action type:
informational_none
Target id:
/class/anticoagulants-antiplatelets
Target name:
Anticoagulants and Antiplatelets
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
As SS-31 is administered by subcutaneous injection, there is a theoretical increased risk of bruising or hematoma formation at the injection site in individuals taking blood-thinning medications.
Actionable advice:
Exercise caution and monitor injection sites for excessive bruising if you are taking anticoagulant or antiplatelet drugs.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
For current labeling information, please visit https://www.fda.gov/drugsatfda
• 5 hours after the last intravenous bolus dose of heparin, or • 4 hours after cessation of a continuous intravenous infusion of heparin, or • 24 hours after the last subcutaneous heparin injection.
Label source:
Action type:
monitor