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FDA PCAC reviews 7 peptides for the 503A bulks list (BPC-157, KPV, TB-500, MOTs-C, Emideltide, Semax, Epitalon). Read our compounder's decision tree. Read our briefing →
FDA PCAC reviews 7 peptides for the 503A bulks list in July. Read →
FDA PCAC: 7 peptides under review. Read →
Mitochondrial-derived peptide
Vialdyne primary owner
This Vialdyne page is the primary SEO owner for buyers evaluating MOTS-c (Human) through a pharmacy QA, clinic procurement, or regulated-sourcing workflow. It should answer whether the buyer can request a batch COA, release-test scope, destination-market review, and add-on documentation before moving into pricing or repeat inventory planning.
Overview
Sequence MRWQEMGYIFYPRKLR, 16 residues, encoded inside the 12S rRNA region of the human mitochondrial genome, MOTS-c is one of the better-characterised members of the mitochondrial-derived peptide (MDP) class. MDPs are a relatively recent addition to the peptide therapeutics universe: they are translated from short open reading frames sitting inside mitochondrial ribosomal RNAs, a class of peptides the textbooks did not acknowledge until the early 2010s. MOTS-c signalling itself runs retrograde, from mitochondrion to nucleus, through AMPK-axis activation; the published research portfolio spans glucose metabolism, insulin-sensitivity endpoints, exercise-capacity studies, body-weight regulation, and the broader landscape of age-related mitochondrial decline. For 503A pharmacies tracking the regulatory pipeline: MOTS-c is currently scheduled on the FDA PCAC July 2026 agenda for review against the 503A bulks list, with proposed indications covering obesity and osteoporosis. For compounding pharmacy buyers, Vialdyne releases MOTS-c acetate as a lyophilised powder against a ≥99.0% main-peak HPLC specification. The standard batch packet pairs RP-HPLC peak integration with ESI-MS at the 2174.6 Da theoretical mass, Karl Fischer water, and counter-ion quantitation; LC-MS/MS sequence verification is available as a documented add-on. Plasma half-life is short, on the order of minutes to a couple of hours, so MOTS-c functions as a tool for acute mitochondrial-signalling protocols rather than sustained-elevation work, repeat dosing or sustained-release formulation is required to hold biological exposure across longer windows. Four nominal strengths from 10 to 40 mg cover both aliquot-scale bench work and small-batch dispensing inside a single qualified supplier line.
Applications & buyer fit
Mitochondrial-targeted peptides ship primarily to research labs studying OXPHOS, ROS biology, and mitochondrial dysfunction in disease models. The lipophilic / cationic character that drives mitochondrial accumulation also makes these peptides somewhat oxidation-prone in solution, working stocks should be prepared fresh or held at -80 °C rather than -20 °C when the workflow permits.
Sourced for
Buyer fit
Documentation that ships
Procurement note: The cationic / lipophilic character makes these peptides oxidation-prone in solution; working stocks are best held cold and prepared fresh.
Primary buyer fit: 503A / 503B compounding pharmacies and academic and contract research laboratories.
Specifications
Certificate of Analysis
Representative COA previews for MOTS-c (Human); request the certificate matched to the offered or supplied lot from sales. These are previews — request the full high-resolution certificate for any lot.
VerifiedRequest full COA →MOTS-c (Human)
VD260428-MS10139 · 99.48%
VerifiedRequest full COA →MOTS-c (Human)
VD260428-MOT140 · 99.66%
VerifiedRequest full COA →MOTS-c (Human)
VD260428-MS20141 · 99.40%
VerifiedRequest full COA →MOTS-c (Human)
VD260428-MS40142 · 99.01%
Independent analytical testing
Product- and strength-matched first-page previews are shown separately from Vialdyne's lot-specific Batch COAs. Reference the report number when requesting the complete, high-resolution file from sales.
Third-party testing in Tianjin
Independent HPLC and mass-spectrometry reports from Qorix , the professional, authoritative third-party analytical laboratory at tjqxgd.com, affiliated with the Tianjin International Joint Academy of Biomedicine.
Regulatory note
MOTS-c is presently before the FDA's PCAC (July 2026) for addition to the 503A bulks list, the proposed indications being obesity and osteoporosis.
Selected literature
Frequently asked questions
MOTS-c was among the earliest mitochondrial-derived peptides (MDPs) identified, a class of short peptides translated from previously-overlooked open reading frames inside mitochondrial ribosomal RNA. The discovery rewrote the textbook claim that mitochondrial DNA encodes only 13 OXPHOS-subunit protein products and exposed a second layer of nucleus-targeted signalling peptides emerging from mitochondrial transcripts. MOTS-c itself signals retrograde, mitochondrion-to-nucleus, activating AMPK-axis pathways and modulating nuclear gene expression in response to metabolic stress. That mechanism is fundamentally distinct from the receptor-pharmacology playbook that dominates the rest of the metabolism and longevity peptide space.
Both molecules sit inside mitochondrial biology but engage it from opposite directions. MOTS-c is an endogenously-encoded signalling peptide that travels retrograde from mitochondrion to nucleus through AMPK and related metabolic-sensor pathways; the effect is gene-expression modulation. SS-31 (Elamipretide) is a synthetic mitochondria-targeted peptide that partitions into the inner mitochondrial membrane and physically protects cardiolipin from peroxidation; the effect is direct biochemical preservation of OXPHOS machinery. The selection criterion is the experimental endpoint, metabolic-signalling and gene-expression work points to MOTS-c, while oxidative-stress and OXPHOS-integrity work points to SS-31.
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