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BPC-157, a Peptide Discovered in 1989, Faces FDA Advisory Review on Compounding Use

Predrag Sikiric's research on the 15-amino-acid peptide began in 1983 and reached an FDA advisory committee scheduled for this summer. The compound is now part of a U.S. policy debate on access to unapproved peptides.

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1 source·Jun 1, 8:30 AM(7 hrs ago)·3m read
BPC-157, a Peptide Discovered in 1989, Faces FDA Advisory Review on Compounding UseStat
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D. student at the University of Zagreb School of Medicine. He and a small team collected gastric juice from clinics, emergency rooms, a hospital in Split, shipments from Bosnia and Herzegovina, and pig slaughterhouses, storing samples in a communal refrigerator in the Department of Pharmacology.

In 1989 the group isolated a 15-amino-acid peptide they named BPC-157. Sikiric later changed the acronym to stand for both "Bože Pomozi Croatia" and "Body Protection Compound," adding the number 157 because July 15, 1990, had been rumored as Croatia's independence date. Croatia declared independence in summer 1991, and war followed.

Pathology professor Sven Seiwerth, who has worked on the project since the 1980s, volunteered as a physician on the front lines while his wife and two young children remained at home. In 1993 Sikiric signed a development contract with the Croatian pharmaceutical company PLIVA.

PLIVA collaborated with Parke-Davis; a 1995 study at the company's Ann Arbor facility found BPC-157 protected rats' colons from harsh chemicals given one hour later.

Researchers at PLIVA and the University of Pécs reported that the peptide protected freshly isolated rat stomach cells. PLIVA conducted two early-stage clinical trials of BPC-157 for ulcerative colitis in the early 2000s. A 2005 short write-up stated the second trial showed a positive effect that did not reach statistical significance.

Michael Parnham, recruited to PLIVA in 1998 as senior scientific adviser, published two papers with colleagues comparing BPC-157 wound healing in rats to standard therapy; the peptide promoted early development of granulation tissue but barely outperformed an existing drug.

In 2006 PLIVA's research institute was sold to GlaxoSmithKline and the rest of the company was acquired by Barr Pharmaceuticals, which Teva Pharmaceuticals bought in 2008. GSK dropped the BPC-157 project.

At the end of 2009 licensing rights and all PLIVA-generated data returned to Sikiric. S. government database.

In a 2025 review Sikiric and his team reported the trial found BPC-157 safe and well-tolerated, though the data have not been published. K. criminologist Luke Turnock.

Sikiric said he felt happiness upon learning of this use and described the essential purpose of the drug as being useful for the people. An FDA advisory committee will consider allowing pharmacies to compound and sell seven unapproved peptides, including BPC-157, this summer.

In an April post on X, Health and Human Services Secretary Robert F. Kennedy Jr. wrote that the committee will weigh the full clinical, pharmacological, and safety evidence for each peptide. The next day he asserted that these peptides are like supplements and therefore might not need to go through clinical trials.

University of Illinois professor Jacob Sherkow said the potential policy shift marks a departure from the FDA's prior treatment of injectable peptides as drugs requiring rigorous evidence. Sikiric, now 72, granted Undark access to his team in May.

Students were interviewed. His main laboratory building was damaged by an earthquake in 2020, leaving boxes and equipment piled in his office, which contains houseplants, a Croatian flag, and photographs of colleagues. Sikiric typically works full days without taking a break to eat.

His father was a prominent patent attorney and outspoken critic of the Communist party who was jailed multiple times. D. research in a European pharmacology journal toward the end of the 1980s.

In 1989 Harvard professor Sandor Szabo invited him to a scientific conference in Canada after reading those papers. Sikiric's theory builds on work by endocrinologist Hans Selye, who published a 1936 Nature paper on the biological stress response, and researcher André Robert, who demonstrated cytoprotection of the stomach lining by prostaglandins.

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