October 15, 2026

HHS Sends Peptide Interim Access Policy to White House, SURPASS-CVOT Heart Failure Analysis, UK Tirzepatide Price Shock

HHS sends a peptide compounding access policy to the White House, tirzepatide shows heart failure signals, and a UK price rise pushed users to semaglutide.

5 stories · Covering regulatory, clinical-trials, industry, research

Editor's Note

Thursday's main event was procedural but large: HHS and the FDA sent an 'interim access policy for compounding using certain peptides' to the White House budget office for review, the first official trace of the temporary-sales plan the Washington Post described last week. The filing has no details; AP's sources say it would let specialty pharmacies make peptides such as BPC-157 under enforcement discretion, which is not approval and would not change the evidence the FDA's own staff called too thin. In the GLP-1 world, an exploratory SURPASS-CVOT analysis found tirzepatide's advantage over dulaglutide on death and heart failure events held in people who already had heart failure, and a UK telehealth study showed how fast self-paying patients moved to semaglutide when tirzepatide's price jumped. Two smaller papers covered a peptide gel that restored fertility in rats with uterine scarring and the thin evidence for CGRP migraine drugs in children.

Regulatory

HHS and FDA Send an 'Interim Access Policy for Compounding Using Certain Peptides' to the White House for Review

HHS and the FDA submitted an "interim access policy for compounding using certain peptides" to the White House Office of Management and Budget for review, according to a government filing reported by Reuters and the Associated Press on October 15, 2026. The filing gives no details, but AP, citing two people familiar with the plan, reported that it would let specialty compounding pharmacies temporarily make some popular peptides, including BPC-157, through enforcement discretion, meaning the FDA would choose not to act against them. Formally adding the peptides to the FDA's compounding list would still require rulemaking, and FDA staff scientists said in July that none had been studied enough to establish safety and effectiveness.

#compounding #bpc-157 #fda #peptide-regulation #hhs

Clinical Trials

SURPASS-CVOT Analysis: Tirzepatide's Edge Over Dulaglutide on Death and Heart Failure Events Held in Patients Who Already Had Heart Failure

An exploratory analysis of Lilly's SURPASS-CVOT trial, published October 15, 2026 in the European Journal of Preventive Cardiology, compared tirzepatide (up to 15 mg) with dulaglutide (1.5 mg) over about four years in people with type 2 diabetes and atherosclerotic heart disease, 20.3% of whom had a history of heart failure. In that heart failure group, tirzepatide was linked to a lower rate of death or heart failure hospitalization or urgent visits (hazard ratio 0.83) and of MACE-4, a composite that adds coronary revascularization (0.81), with similar but weaker trends in people without heart failure. The authors called the analysis exploratory, since the trial's main result was noninferiority.

#tirzepatide #surpass-cvot #cardiovascular #eli-lilly

Industry

After a Tirzepatide List-Price Increase of Up to 170%, UK Self-Paying Patients Shifted Toward Semaglutide, Telehealth Study of 1 Million Adults Finds

Researchers from the UK telehealth company HeliosX and consultancy Lane Clark & Peacock reported in Diabetes, Obesity and Metabolism on October 14, 2026 a study of 1,033,522 self-paying adults who started semaglutide or tirzepatide through MedExpress between May 2024 and January 2026. After tirzepatide's UK list price rose by up to 170% in September 2025, semaglutide starts rose 31.15 percentage points above the earlier trend and switching from tirzepatide to semaglutide rose 9.26 points before easing. Estimated 12-month weight loss was 19.93% with tirzepatide and 16.40% with semaglutide, though the semaglutide estimate rested on only 979 people.

#tirzepatide #semaglutide #pricing #telehealth #united-kingdom

Research

Peptide Hydrogel Loaded With Puerarin Restores Uterine Lining and Pregnancy Rates in Rats With Intrauterine Adhesions

Researchers at the First Affiliated Hospital of Wenzhou Medical University reported in ACS Applied Materials & Interfaces on October 15, 2026 an injectable, biodegradable peptide hydrogel that slowly releases puerarin, an anti-scarring plant compound, inside the uterus. In rats with intrauterine adhesions, scar tissue that is a leading cause of infertility, the gel acted as a physical barrier, restored the uterine lining's glands and blood vessels, reduced fibrosis, and markedly raised pregnancy rates. The results are from rats.

#peptide-hydrogel #fertility #drug-delivery #preclinical

Research

Review: Evidence for CGRP Migraine Drugs in Children Rests on One Randomized Trial and a Handful of Real-World Studies

A narrative review published October 14, 2026 in Current Pain and Headache Reports found that the evidence for CGRP-targeting migraine treatments in people under 18 consists of one randomized controlled trial, of fremanezumab (Ajovy) in children aged 6 to 17 with episodic migraine, which showed benefit, plus several small real-world studies. CGRP drugs have been used in adults since 2018, and the authors said trials of other CGRP-targeting drugs in children are still pending.

#cgrp #migraine #pediatrics #fremanezumab