Regulated path
Compounded or prescribed access should happen through licensed clinicians and pharmacies where lawfully available.
2026 FDA Peptide Compounding Watchlist
Follow profile-linked peptide-related FDA compounding signals, filter by watch status or use case, and jump directly to each research profile.
Editorial resource only. PeptideUnicorn does not prescribe, dispense, or route care.
Overview
20 peptides tracked
- PCAC Review 7
- Safety-Risk Signal 6
- Category 3 2
- Route-Specific 1
- Approved-Drug Context 2
- Monitor 2
Top use cases
- Growth hormone 6
- Recovery 4
- Body composition 4
- Metabolic 3
- Cognitive 3
- Longevity 3
Editorial confidence
High 16
Medium 2
Low 2
Confidence reflects source clarity and analogous jurisdiction signals, not a prediction.
Last updated: 28 May 2026
This tracker is an editorial summary of public regulatory signals. It is not medical or legal advice, and it does not route care or sales.
20 peptides shown
| Peptide | Common name | FDA signal | Watch status | Confidence | Use cases | MHRA status | TGA status | Last updated | Source |
|---|---|---|---|---|---|---|---|---|---|
| BPC-157 FDA has identified peptide-related safety concerns and scheduled BPC-157-related substances for PCAC discussion. | Body Protection Compound 157 | Safety-risk page; PCAC review scheduled | PCAC review July 2026 | High Shifted | RecoveryGI research | Research chemical; not licensed as a medicine | Unapproved/prescription context depends on product claim and access pathway | 2026-05-28 | FDA PCAC notice |
| KPV FDA discusses KPV on its safety-risk page and scheduled KPV-related substances for PCAC review. | Lysine-Proline-Valine | Safety-risk page; PCAC review scheduled | PCAC review July 2026 | High Shifted | ImmuneGI researchWound healing | Research chemical; not licensed as a medicine | Not listed; supply claims require case-by-case review | 2026-05-28 | FDA PCAC notice |
| TB-500 FDA safety-risk language discusses TB-500, and TB-500-related substances are scheduled for PCAC review. | Thymosin Beta-4 fragment | Safety-risk page; PCAC review scheduled | PCAC review July 2026 | High | RecoveryWound healing | Research chemical; not licensed as a medicine | Unapproved/prescription context depends on product claim and access pathway | 2026-05-28 | FDA PCAC notice |
| CJC-1295 FDA safety-risk language identifies concerns around CJC-1295, including limited clinical data and reported adverse events. | Growth hormone releasing hormone analog | FDA safety-risk page | Safety-risk signal | High | Growth hormoneBody composition | Research chemical; not licensed as a medicine | Unapproved/prescription context depends on product claim and access pathway | 2026-05-28 | FDA safety-risk page |
| Ipamorelin FDA lists ipamorelin acetate under 503B Category 2 and discusses peptide-related safety concerns. | Growth hormone secretagogue | 503B Category 2; safety-risk page | Safety-risk signal | High | Growth hormoneRecovery | Research chemical; not licensed as a medicine | Unapproved/prescription context depends on product claim and access pathway | 2026-05-28 | FDA safety-risk page |
| AOD-9604 FDA's safety-risk page discusses AOD-9604 and notes limited safety information and reported serious adverse events. | Modified hGH fragment 176-191 | FDA safety-risk page | Safety-risk signal | High | Weight lossMetabolic | Research chemical; not licensed as a medicine | Unapproved/prescription context depends on product claim and access pathway | 2026-05-28 | FDA safety-risk page |
| Selank FDA's safety-risk page discusses selank acetate and notes limited information about safety issues in humans. | Tuftsin analog | FDA safety-risk page | Safety-risk signal | High | CognitiveStress research | Research chemical; not licensed as a medicine | Not listed; supply claims require case-by-case review | 2026-05-28 | FDA safety-risk page |
| Semax FDA discusses semax on its safety-risk page and scheduled semax-related substances for PCAC review. | ACTH fragment analog | Safety-risk page; PCAC review scheduled | PCAC review July 2026 | High | CognitiveNeuroprotection | Research chemical; not licensed as a medicine | Not listed; supply claims require case-by-case review | 2026-05-28 | FDA PCAC notice |
| Thymosin Alpha-1 FDA's safety-risk page discusses thymosin-alpha 1 and says available safety information is inadequate for compounded-use conclusions. | Thymalfasin | FDA safety-risk page | Safety-risk signal | High | ImmuneInfectious disease research | Research chemical; not licensed as a medicine | Unapproved/prescription context depends on product claim and access pathway | 2026-05-28 | FDA safety-risk page |
| GHK-Cu FDA's May 2026 503A update added non-injectable GHK-Cu back to Category 1 while injectable GHK-Cu remains a safety-risk signal. | Copper tripeptide-1 | Route-specific 503A signal | Route-specific | High | Skin and hairLongevity | Cosmetic/research framing varies by product claim | Cosmetic/research framing varies by product claim | 2026-05-28 | FDA 503A category PDF |
| MOTS-c FDA discusses MOTs-C on its safety-risk page and scheduled MOTs-C-related substances for PCAC review. | Mitochondrial open reading frame peptide | Safety-risk page; PCAC review scheduled | PCAC review July 2026 | High | MetabolicLongevity | Research chemical; not licensed as a medicine | Not listed; supply claims require case-by-case review | 2026-05-28 | FDA PCAC notice |
| Epitalon FDA discusses epitalon on its safety-risk page and scheduled epitalon-related substances for PCAC review. | Epithalon tetrapeptide | Safety-risk page; PCAC review scheduled | PCAC review July 2026 | High | LongevitySleep | Research chemical; not licensed as a medicine | Not listed; supply claims require case-by-case review | 2026-05-28 | FDA PCAC notice |
| Melanotan II FDA's safety-risk page discusses melanotan II and cites serious adverse-event case reports. | Melanocortin receptor agonist | FDA safety-risk page | Safety-risk signal | High | Skin and hairSexual health | Unlicensed medicine; enforcement history around tanning products | Restricted; not approved for tanning use | 2026-05-28 | FDA safety-risk page |
| PT-141 Bremelanotide has an FDA-approved drug form, but that does not automatically resolve broader compounded or research-product sourcing questions. | Bremelanotide | FDA-approved drug context | Approved-drug context | Medium | Sexual health | Prescription medicine context where supplied | Prescription-only context where supplied | 2026-05-28 | FDA compounding overview |
| DSIP FDA discusses emideltide/DSIP on its safety-risk page and scheduled DSIP-related substances for PCAC review. | Delta sleep-inducing peptide | Safety-risk page; PCAC review scheduled | PCAC review July 2026 | High | SleepCognitive | Research chemical; not licensed as a medicine | Not listed; supply claims require case-by-case review | 2026-05-28 | FDA PCAC notice |
| Sermorelin Sermorelin remains relevant to growth-hormone-releasing peptide research, but it was not confirmed in the current FDA source set used for this watchlist update. | GRF 1-29 | No current 503A peptide signal confirmed in reviewed FDA sources | Monitor | Low | Growth hormoneBody composition | Research chemical; not licensed as a medicine | Unapproved/prescription context depends on product claim and access pathway | 2026-05-28 | FDA compounding overview |
| Tesamorelin Tesamorelin has an established pharmaceutical context, but compounded or research-product sourcing remains a separate regulatory question. | Growth hormone releasing factor analog | FDA-approved drug context | Approved-drug context | Medium | MetabolicBody composition | Prescription medicine context where supplied | Prescription-only context where supplied | 2026-05-28 | FDA compounding overview |
| Hexarelin Hexarelin is a growth-hormone secretagogue of anti-doping concern, but it was not confirmed in the current FDA source set used for this watchlist update. | Growth hormone secretagogue | No current 503A peptide signal confirmed in reviewed FDA sources | Monitor | Low | Growth hormoneRecovery | Research chemical; not licensed as a medicine | Not listed; supply claims require case-by-case review | 2026-05-28 | FDA compounding overview |
| GHRP-2 FDA's May 2026 503A PDF lists GHRP-2 in Category 3, while FDA's safety-risk page lists GHRP-2 for injectable and nasal routes under 503B Category 2. | Growth hormone releasing peptide-2 | 503A Category 3; 503B Category 2 safety-risk signal | Category 3 | High | Growth hormoneBody composition | Research chemical; not licensed as a medicine | Not listed; supply claims require case-by-case review | 2026-05-28 | FDA 503A category PDF |
| GHRP-6 FDA's May 2026 503A PDF lists GHRP-6 in Category 3, while FDA's safety-risk page lists GHRP-6 under 503B Category 2. | Growth hormone releasing peptide-6 | 503A Category 3; 503B Category 2 safety-risk signal | Category 3 | High | Growth hormoneAppetite | Research chemical; not licensed as a medicine | Not listed; supply claims require case-by-case review | 2026-05-28 | FDA 503A category PDF |
What this means for readers
Research path
Research-vendor coverage is education-only. PeptideUnicorn does not recommend research chemicals for personal use.
Wait and see
Watchlist entries should be treated as unresolved until primary-source regulatory guidance is clearer.
Methodology
How we maintain the tracker
Tracker rows are maintained from primary regulatory sources and editorial review. Confidence reflects source clarity, public FDA category language, safety-risk language, and whether the peptide has a clearer prescription or research-only pathway in comparable jurisdictions.
We do not prescribe, dispense, route care, or rank regulatory outcomes by affiliate value.
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Latest tracker updates
KPV added to PCAC tracker coverage
2026-05-28Row-level tracker audit added KPV because FDA's July 2026 PCAC notice lists KPV-related bulk drug substances for discussion.
Source: US regulatory referenceTracker language updated to FDA source signals
2026-05-28PeptideUnicorn replaced forecast-style category labels with source-based signals: PCAC review, FDA safety-risk page, Category 3, route-specific, approved-drug context, and monitor.
Source: US regulatory referenceFDA posts July 2026 PCAC peptide agenda
2026-05-28FDA's July 23-24, 2026 PCAC notice covers BPC-157, KPV, TB-500, MOTs-C, DSIP, Semax, and Epitalon-related bulk drug substances.
Source: US regulatory referenceGHK-Cu route-specific 503A status updated
2026-05-14FDA's May 14, 2026 503A PDF adds GHK-Cu, except injectable routes of administration, back to Category 1 after a nominator clarified the withdrawal scope.
Source: US regulatory reference Coverage Queue
FDA-listed signals still waiting on profile coverage
The main table only includes rows with a PeptideUnicorn profile link. These additional FDA-listed peptide-related or adjacent substances are visible here until profile pages, source notes, and review status are completed.
Cathelicidin LL-37
FDA safety-risk page
FDA lists cathelicidin LL-37 in withdrawn safety-risk language; no profile row exists yet.
FDA source →Dihexa acetate
FDA safety-risk page
FDA lists dihexa acetate in withdrawn safety-risk language; profile coverage is pending.
FDA source →Kisspeptin-10
503A Category 2 signal
FDA lists kisspeptin-10 under Category 2 of the 503A interim policy; profile coverage is pending.
FDA source →PEG-MGF
FDA safety-risk page
FDA lists pegylated mechano growth factor in withdrawn safety-risk language; profile coverage is pending.
FDA source →Ibutamoren mesylate
Adjacent 503A/503B signal
FDA lists ibutamoren mesylate under Category 2; it is adjacent to peptide-hormone coverage rather than a peptide profile.
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