Regulatory Tracker
Peptide Regulatory Status (2026)
The peptide regulatory landscape has changed significantly since February 2026, when HHS reinstated 14 previously restricted compounds for legal compounding. This page tracks the current FDA approval status, compounding legality, and HHS classification for every compound in our database.
This page tracks current regulatory status only. For the historical narrative and forward-looking analysis, see the 2026 State of Peptides & GLP-1 Regulation report.
Tracker facts for search and AI answers
What this regulatory tracker answers
Tracker scope
61 peptide and GLP-1 compounds plus 18 pipeline approval pages
The index separates currently regulated peptide entries from pipeline approval/timeline pages.
Last review
April 6, 2026
Regulatory status changes can affect compounding, prescribing, and patient access assumptions.
How to use it
Check FDA approval, compounding legality, HHS status, and pipeline launch timing separately
Approved, compounded, investigational, and watchlist status are different access categories.
Next step
Open the compound or status page before treating a product as available
The index is a triage page; individual pages carry the detailed mechanism, evidence, and access read.
Approval and Timeline Pages
Pipeline approval pages for the names people will search next
Triple agonists
Retatrutide
Not approved in the US for broad obesity use as of this tracker update.
2027 earliest if the Phase 3 and filing path stay clean.
Triple agonists
Survodutide
Not approved in the US for obesity at this stage.
2027 to 2028 if the late-stage data and filing sequence stay on track.
Triple agonists
Mazdutide
China progress is more advanced; US approval is still not the current reality.
US timeline remains uncertain and should be treated as later than the China story.
Dual agonists
Amycretin (Zenagamtide)
Not yet approved for broad obesity use.
2027 to 2028 is the realistic window if development continues smoothly.
Dual agonists
MariTide (maridebart cafraglutide)
Not approved in the US for broad obesity use.
2027 to 2028 if Amgen converts the mechanism into a clean filing story.
Dual agonists
VK2735
Not approved in the US today.
2027 is the optimistic window if the late-stage path stays clean.
Dual agonists
CagriSema
FDA-filed, which is materially closer to market than a Phase 3-only program.
Late 2026 to 2027 depending on decision timing and launch rollout.
Dual agonists
Pemvidutide
Not approved and still meaningfully pre-launch.
2028 or later is the realistic broad-launch frame.
Dual agonists
CT-388
Not approved in the US today.
2028 or later if the development path accelerates cleanly.
Dual agonists
Ecnoglutide (XW003)
Advanced program, but not a broadly approved US obesity product in this tracker.
2027 to 2028 depending on geography and filing strategy.
Next-generation GLP-1
Orforglipron
FDA milestone reached in April 2026 per the current FormBlends pipeline tracker.
Near-term commercial rollout is the live question now, not distant approval speculation.
Next-generation GLP-1
PF-3944 (MET-097i)
Not approved today for broad US obesity use.
2027 or later if the Phase 3 and filing process hold together.
Next-generation GLP-1
Aleniglipron
Not approved.
2028 or later if development continues cleanly.
Next-generation GLP-1
Danuglipron
Not approved in the US today.
2028 or later if the program stabilizes.
Next-generation GLP-1
Elecoglipron (AZD5004)
Not approved and still early in development.
2029 or later if development stays alive and improves.
Amylin pathway
Petrelintide
Not approved.
2028 or later if the program advances cleanly.
Amylin pathway
Cagrilintide
Standalone broad-obesity approval is not the current story.
Standalone broad launch timing is less clear than the combination story.
Amylin pathway
AZD6234
Not approved.
2028 or later if AstraZeneca advances it aggressively.
Track company-level FDA actions
Our Safety Newsroom tracks FDA warning letters, recalls, and enforcement actions for specific GLP-1 telehealth companies and compounding pharmacies.
Visit Safety Newsroom →What Changed in 2026
14 Peptides Reinstated for Compounding (February 2026)
HHS Secretary RFK Jr. announced that 14 peptides previously restricted by the FDA would return to legal compounding status. This reversed restrictions put in place in late 2023 that had limited access to compounds like BPC-157, thymosin alpha-1, and others through compounding pharmacies. The decision followed pressure from practitioners, patients, and industry groups who argued the restrictions reduced access without improving safety.
FDA Compounding Rules Remain in Effect
While individual peptides were reinstated, the overall FDA framework for compounding hasn't changed. Compounded medications must still be prepared by registered 503A or 503B pharmacies, prescribed by a licensed physician, and intended for an individual patient (503A) or distributed without patient-specific prescriptions (503B outsourcing facilities).
GLP-1 Compounding Under Scrutiny
Semaglutide and tirzepatide compounding remains legal as of April 2026, though brand manufacturers (Novo Nordisk and Eli Lilly) continue to challenge the legal basis for compounding these drugs. The FDA's determination of ongoing drug shortages is the key factor: as long as shortages persist, compounding pharmacies can legally prepare these medications.
Compound Status Table
This table covers every individual compound in our database. Click any compound name to read the full profile.
| Compound | Evidence | FDA Approved | Compounding Legal | 2026 HHS Status |
|---|---|---|---|---|
| 5-Amino-1MQ(Metabolic) | Emerging Evidence | No | Yes | -- |
| AHK-Cu Copper Peptide(Skin & Hair) | Emerging Evidence | No | Yes | -- |
| Anastrozole(HRT) | Moderate Evidence | Yes | Yes | -- |
| AOD-9604(Weight Loss) | Moderate Evidence | No | No | Expected to return to Category 1 (compoundable) per HHS announcement, pending formal publication |
| BPC-157(Recovery) | Moderate Evidence | No | Yes | Reinstated for compounding (Feb 2026) |
| CJC-1295(Growth Hormone) | Moderate Evidence | No | Yes | Reinstated for compounding (Feb 2026) |
| CJC-1295 with DAC(Growth Hormone) | Moderate Evidence | No | Yes | Reinstated for compounding (Feb 2026) |
| Clomiphene Citrate(HRT) | Moderate Evidence | Yes | Yes | -- |
| DHEA(HRT) | Moderate Evidence | Yes | Yes | Not affected (OTC supplement and FDA-approved intravaginal form) |
| Dihexa(Cognitive) | Emerging Evidence | No | No | -- |
| DSIP(Cognitive) | Emerging Evidence | No | No | Expected to return to Category 1 (compoundable), pending formal publication |
| DSIP(Sleep & Stress) | Emerging Evidence | No | No | -- |
| Enclomiphene(HRT) | Strong Evidence | No | Yes | Not affected by 2026 peptide reclassification (small molecule SERM) |
| Epithalon(Longevity) | Emerging Evidence | No | Yes | Not specifically addressed in 2023/2026 regulatory actions |
| Estradiol(HRT) | Strong Evidence | Yes | Yes | Not affected (FDA-approved compound) |
| Follistatin 344(Muscle Growth) | Emerging Evidence | No | No | Category 2 (restricted); reclassification status unclear pending formal FDA publication |
| Follistatin 344(Growth) | Emerging Evidence | No | No | -- |
| GHK-Cu(Skin and Healing) | Moderate Evidence | No | Yes | Reinstated for compounding (Feb 2026) |
| GHRP-2(Growth Hormone) | Moderate Evidence | No | No | Expected to remain Category 2 (restricted from compounding) |
| GHRP-2(Growth Hormone) | Moderate Evidence | No | Yes | Reinstated for compounding (Feb 2026) |
| GHRP-6(Growth Hormone) | Moderate Evidence | No | No | Expected to remain Category 2 (restricted from compounding) |
| GHRP-6(Growth Hormone) | Moderate Evidence | No | Yes | Reinstated for compounding (Feb 2026) |
| Glutathione(Immune) | Moderate Evidence | No | Yes | Not affected by peptide compounding restrictions |
| Gonadorelin(HRT) | Moderate Evidence | Yes | Yes | Available through compounding pharmacies without restrictions |
| HCG(HRT) | Strong Evidence | Yes | Yes | Available through compounding pharmacies under biologic compounding provisions |
| Hexarelin(Growth Hormone) | Moderate Evidence | No | No | Not on Category 2 list; not affected by 2026 reclassification |
| Humanin(Anti-Aging) | Emerging Evidence | No | Yes | Not specifically addressed in 2023/2026 regulatory actions |
| IGF-1 LR3(Muscle Growth) | Emerging Evidence | No | No | Not on Category 2 list; not affected by 2026 reclassification |
| Ipamorelin(Growth Hormone) | Moderate Evidence | No | Yes | Reinstated for compounding (Feb 2026) |
| Kisspeptin(Hormonal) | Moderate Evidence | No | Yes | Not specifically addressed in 2023/2026 regulatory actions |
| KPV(Recovery) | Emerging Evidence | No | Yes | -- |
| Larazotide(Gut Health) | Moderate Evidence | No | Yes | -- |
| LL-37(Immune) | Moderate Evidence | No | Yes | -- |
| Melanotan II(Skin and Healing) | Emerging Evidence | No | No | Expected to remain Category 2 (restricted) due to safety concerns |
| MK-677(Growth Hormone) | Moderate Evidence | No | Yes | Not affected by 2023 peptide restrictions (non-peptide compound) |
| MOTS-c(Metabolic) | Emerging Evidence | No | Yes | Not specifically addressed in 2023/2026 regulatory actions |
| NAD+(Longevity) | Moderate Evidence | No | Yes | Not affected by 2023 restrictions |
| NMN(Anti-Aging) | Moderate Evidence | No | Yes | Not affected (dietary supplement) |
| Orforglipron(Weight Loss) | Strong Evidence | Yes | No | FDA-approved product; standard drug compounding rules apply |
| Oxytocin(Sexual Wellness) | Emerging Evidence | Yes | Yes | -- |
| Pregnenolone(HRT) | Moderate Evidence | No | Yes | -- |
| Progesterone(HRT) | Strong Evidence | Yes | Yes | Not affected (FDA-approved compound) |
| PT-141(Sexual Health) | Strong Evidence | Yes | Yes | Not affected (FDA-approved compound) |
| Retatrutide(Weight Loss) | Strong Evidence | No | No | Investigational, not eligible for compounding |
| Selank(Cognitive) | Emerging Evidence | No | Yes | Not specifically addressed in 2023/2026 regulatory actions |
| Semaglutide(Weight Loss) | Strong Evidence | Yes | Yes | Compounding permitted under 503A/503B with documented medical necessity |
| Semax(Cognitive) | Emerging Evidence | No | Yes | Not specifically addressed in 2023/2026 regulatory actions |
| Sermorelin(Growth Hormone) | Moderate Evidence | No | Yes | Not affected by 2023 restrictions |
| SNAP-8(Skin & Hair) | Emerging Evidence | No | Yes | -- |
| SS-31(Anti-Aging) | Emerging Evidence | No | Yes | Not specifically addressed in 2023/2026 regulatory actions |
| TB-500(Recovery) | Emerging Evidence | No | Yes | Reinstated for compounding (Feb 2026) |
| Tesamorelin(Growth Hormone) | Strong Evidence | Yes | Yes | Not affected by 2023 restrictions or 2026 reclassification |
| Tesamorelin(Growth Hormone) | Strong Evidence | Yes | Yes | -- |
| Tesofensine(Weight Loss) | Moderate Evidence | No | Yes | Not a peptide; not affected by peptide compounding regulations |
| Testosterone Cypionate(HRT) | Strong Evidence | Yes | Yes | Not affected (FDA-approved compound) |
| Testosterone Enanthate(HRT) | Strong Evidence | Yes | Yes | -- |
| Thymosin Alpha-1(Immune) | Strong Evidence | No | Yes | Reinstated for compounding (Feb 2026) |
| Thymosin Beta-4(Recovery) | Moderate Evidence | No | Yes | Reinstated for compounding (Feb 2026) alongside TB-500 |
| Thymulin(Immune) | Emerging Evidence | No | No | -- |
| Tirzepatide(Weight Loss) | Strong Evidence | Yes | Yes | Compounding limited to documented medical necessity under 503A |
| VIP(Recovery) | Moderate Evidence | No | Yes | -- |
How to Read This Table
FDA Approved
A "Yes" means the compound has gone through full FDA clinical trials and received approval for specific medical uses. Most peptides are not FDA-approved, which doesn't mean they're unsafe. It means they haven't gone through the multi-year, multi-billion-dollar approval process.
Compounding Legal
A "Yes" means the compound can be legally prepared by FDA-registered compounding pharmacies when prescribed by a licensed physician. The February 2026 HHS reclassification restored compounding rights for 14 peptides that had been restricted.
Evidence Grade
Our evidence grading reflects the quality and quantity of published research. "Strong" means multiple human clinical trials in peer-reviewed journals. "Moderate" means limited human data with extensive animal research. "Emerging" is primarily preclinical. "Anecdotal" means limited published data.
2026 HHS Status
This tracks the compound's status following the February 2026 HHS announcement. "Reinstated" means it was previously restricted and is now available again for compounding. Compounds not affected by the 2023 restrictions show no change.
Frequently Asked Questions
Which peptides were reinstated for compounding in 2026?
Is it legal to buy compounded peptides?
What is the difference between FDA-approved and compounded peptides?
How often does this page get updated?
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