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FDA Announces Change in Status of 12 Peptides

BREAKING NEWS APRIL 15, 2026 - In a welcome announcement to the SSRP community, the FDA reported today that it will imminently remove the following bulk drug substances from category 2: BPC-157, LL-37, DiHexa, DSIP, Epitalon, *GHK-Cu (injectable only), KPV, PE

Written by Peptide Therapy Guide Editorial Team
For education only

This guide cannot diagnose a condition or recommend a personal treatment plan. Discuss medical questions with a qualified professional.

BREAKING NEWS

APRIL 15, 2026 - In a welcome announcement to the SSRP community, the FDA reported today that it will imminently remove the following bulk drug substances from category 2: BPC-157, LL-37, DiHexa, DSIP, Epitalon, *GHK-Cu (injectable only), KPV, PEG-MGF, Melanotan II, MOTs-C, Semax, and TB-500. Originally nominated for Category 2 (Bulk Substances that Raise Significant Safety Concerns), the withdrawal of these nominations would indicate that the FDA is reconsidering the validity of respective safety concerns. Removal from Category 2 also lessens restrictions on US compounding pharmacies ability to produce these peptides. The FDA announcement also suggests that its July 2026 meeting will, in short order, explore giving these peptides full approval. *Non-injectibile GHK-Cu has also been singled out for further consideration by February 2027.

William Seeds, MD, Founder of the SSRP Institute and recognized globally as the pioneer and leading authority on peptide therapy, points out, “this is not just exciting news; it’s also a testament to the power of what we know are effective agents that have been shown to accelerate healing, protect immunity, and restore cellular function when applied under the care of a trained provider. It’s about time.”

Learn More

Click here to read the FDA announcement. For future updates like this, education, training, and support, explore what the SSRP community has to offer.

Alpha-Gal Syndrome: An Update on Incidence Rate by the CDC

HEADLINE SCIENCE JAMA recently published a report about the incidence rate of alpha-gal syndrome, which is a serious allergic reaction to a sugar molecule called alpha-gal, which is found in most mammals. It is typically transmitted through a bite from a Lone Star tick or other tick species that injects the molecule into the body, […]

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VIDEO

Cellular Medicine Mondays

Aug 17, 2026

Ep. 101 - Office Hours: PWC26 Virtual Summit Part 3

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Office Hours PWC26 Virtual Summit Part 3 – Episode 101

Office Hours PWC26 Virtual Summit Part 3 – Episode 101

1. Mitochondrial peptides (1:07)
2. MOTS-c cycle (3:50)
3. Injury site specific injection (9:25)
4. BPC-157 dosing (15:18)
5. Trusted labs (20:56)
6. What “redox” means (25:48)
7. Patient with cervical fusion, pain, and decreased range of motion (31:36)
8. Lipedema (37:03)
9. SS-31 and MOTS-c (37:52)
10. NanoVI device (44:49)
11. NAD (48:13)

SSRP Institute Welcomes IntellxxDNA as New Trusted Partner

PARTNER ANNOUNCEMENT WILLOUGHBY, Ohio, [August 12, 2026] — The SSRP Institute welcomes IntellxxDNA to its Trusted Partner Network following a nomination and internal vetting process, aligning with SSRP’s mission to advance science-first, education-driven clinical collaboration. IntellxxDNA provides clinicians with a structured genomic decision support platform that translates complex genetic data into clinically actionable insights. Using […]

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VIDEO

Cellular Medicine Mondays

Aug 10, 2026

Ep. 100 - Office Hours: PWC26 Virtual Summit Part 2

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Office Hours PWC26 Virtual Summit Part 2 – Episode 100

Office Hours PWC26 Virtual Summit Part 2 – Episode 100

  1. Evaluating terrain of the patient (1:43)
  2. SS31 peptide in practice (8:50)
  3. Phenotyping the right patient for GLP-1 therapy (11:18)

William Seeds, MD Aug 6, 2026

A Lipid at the Root of Mitochondrial Aging: Phosphatidylcholine, Methylation, and a Malleable Therapeutic Window

Mitochondrial dysfunction is one of the most firmly established hallmarks of aging, but the field has spent far more energy describing genetic causes of mitochondrial failure—mtDNA mutation, defective OXPHOS, impaired unfolded protein response—than the “natural” drivers that erode mitochondria during ordinary aging. As I discussed in my recent June Journal Club (as well as a […]

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VIDEO

Cellular Medicine Mondays

Aug 3, 2026

Ep. 099 - Office Hours: PWC26 Virtual Summit Part 1

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Office Hours: PWC26 Virtual Summit Part 1 – Episode 099

Office Hours: PWC26 Virtual Summit Part 1 – Episode 099

This special edition of Office Hours features questions submitted during the Peptide World Congress Virtual Summit on July 10 and 11. Dr. Seeds and Dr. Newman address:

  1. GLOW Stack, MOTS c, and Thyroid Function (0:50)
  2. Should the GLOW Stack Be Separated? (3:31)
  3. Peptides in Transplant Medicine (8:02)
  4. Biomarker Monitoring (13:21)
  5. Peptides in Acute and Long Term Stroke Recovery (17:37)
  6. Autoimmunity and the GI Tract (23:00)
  7. Cancer Concerns Related to Hormones and Angiogenesis (26:49)

VIDEO

Cellular Medicine Mondays

Jul 27, 2026

Ep. 098 - Pentosan Polysulfate: Dosing, Safety, and Monitoring

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Dissecting Protocols – Episode 098

Pentosan Polysulfate: Dosing, Safety, and Monitoring

Dr. Seeds examines the subcutaneous use of pentosan polysulfate, addressing concerns about injection site scarring and ocular safety. He discusses dosing, site rotation, cumulative exposure, retinal screening, and strategies for responsible, individualized treatment.(Question Link)

PCAC Meeting Vote Summary

BREAKING NEWS JULY 24, 2026 – The Pharmacy Compounding Advisory Committee (PCAC) has completed its July session, voting on several peptide bulk drug substances for potential inclusion on the FDA’s 503A Bulks List.Recommended FOR inclusion: (Yes-No)• BPC-157 (8–6)• KPV (8–6)• TB-500 (8–6)• MOTS-c (7–5)• Epitalon (7–4)• Semax (8–5)Recommended AGAINST inclusion: (Yes-No)• DSIP (6–7) What happens […]

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VIDEO

Cellular Medicine Mondays

Jul 20, 2026

Ep. 097 - Creatine: Evidence, Pathways, and Hype

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Rabbit Holes – Episode 097

Creatine: Evidence, Pathways, and Hype

Dr. Seeds examines creatine through a cellular medicine lens, separating evidence-supported uses in ATP buffering, performance, and methylation from claims that exceed current clinical data.

William Seeds, MD Jul 14, 2026

The Renin–Angiotensin–Aldosterone System (RAAS): Beyond Blood Pressure Regulation

After a recent Journal Club episode in which I featured, The Renin–Angiotensin–Aldosterone System (RAAS): Beyond Cardiovascular Regulation, I wanted to return to the article and expand a bit on the significance of the Renin–Angiotensin–Aldosterone System (RAAS). As we know, the RAAS system has traditionally been viewed as the body’s primary mechanism for regulating blood pressure, […]

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Peptide Therapy Guide Editorial Team

Editorial team for Peptide Therapy Guide.

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