The company is investing to be first-in-class in secure, legal, U.S.-based peptide manufacturing and dispensing — positioning it to serve patients and providers as an FDA advisory committee signals a widening lawful pathway for compounded peptides.

FISHERS, Ind., Aug. 5, 2026 /PRNewswire/ -- 1Elevan Biopharmaceuticals, Inc. ("1Elevan Bio"), an emerging 503A compounding pharmacy headquartered in Fishers, Indiana, is investing substantially in the infrastructure needed to be the trusted partner for patients and providers seeking peptide therapeutics. They are building toward an expansive model from domestic API manufacturing to pharmacy dispensing to real-world monitoring of patient outcomes and adverse events.

The build-out comes as the U.S. Food and Drug Administration's Pharmacy Compounding Advisory Committee (PCAC), at a meeting held July 23–24, 2026, considered seven peptides for inclusion on the affirmative list of bulk drug substances that may be used by pharmacies compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. The Committee recommended that six be added (BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax), while voting against the addition of Emideltide, covering all four substances 1Elevan Bio addressed in the public comment it submitted to the docket on July 9, 2026.

"Our focus is on ensuring patients and providers have a partner they can trust for the long run," said Darrin Carrico, President and CEO of 1Elevan Bio. "We are seeing prescribers ask about these substances by name, and patients who are already seeking them out today. As a result, we have been working to put in place what we anticipate can become some of the most rigorous, compliance-first manufacturing and pharmacy infrastructure in the space, with the goal that if and when patients and providers are looking for both continuity and a secure, legal source, we are positioned to help offer that."

The investment beyond compounding capabilities signals 1Elevan Bio's commitment to supporting the entire patient journey. Practically, that means securing American manufacturing, engaging providers, and ensuring tailored medicines are accessible to patients. This "whole-of-value-chain" approach is both a differentiator for the company and aligned with the executive team's experience in empowering patients.

"Many companies in this space are focusing on one piece of the chain whether it be manufacturing, or pharmacy, or a telehealth front end," Carrico said. "We are investing across every stage of the process, because that's what it takes to actually be truly first-in-class — U.S.-based supply, a licensed pharmacy dispensing it, and real outcomes data on how it performs. That's the standard we believe patients and providers deserve, and we're building to meet it."

Importantly, the Committee's action is a recommendation and does not change what any pharmacy may lawfully compound today. PCAC's votes are advisory and not binding on the FDA, and pharmacies will not be permitted to compound these substances until final rulemaking is in place. The remaining pathway requires formal placement on the Bulks List through notice-and-comment rulemaking.

1Elevan Bio has offered to serve as a resource to the Committee and to FDA as the agency considers reasonable conditions for use and will continue to participate in the rulemaking process.

About 1Elevan Biopharmaceuticals

Founded in 2022, 1Elevan Bio is transforming healthcare through integrated therapeutics and innovative care delivery. We provide FDA-compliant peptides, specialized compounding services, hormone replacement therapies, and solid organ transplant therapeutics. 1Elevan Bio combines pharmacy operations with future cGMP manufacturing to expand safe, provider-directed access to high-quality therapeutics — grounded in validated sourcing, structured compliance, and long-term domestic investment. Our commitment to precision medicine and advanced delivery systems is redefining how diseases are treated—with enhanced efficacy, superior safety, and better patient outcomes. Learn more at https://1elevan.com.

Media Contact: media@1elevan.com

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SOURCE 1Elevan Bio