The Latest News in the Peptide World

This summer was a busy one in the peptide space. We're seeing game-changing innovations in peptide science, with drugs that can be delivered orally, act as targeted therapies, and serve as the basis for cancer vaccines and tissue regeneration scaffolds. These recent advancements are highlighting the incredible versatility of peptides, moving beyond traditional applications to address a range of diseases from rare genetic disorders to common metabolic conditions and cancers.

Check out our Q3 news roundup below.

Cerapedics announced that the first patient in the U.S. has been treated with their PearlMatrix™ P-15 Peptide Enhanced Bone Graft. The P-15 Peptide, a sequence derived from Type-1 collagen, acts as a cell attachment factor to promote bone regeneration by providing numerous attachment sites for bone-forming cells. Cerapedics recently received FDA approval for the P-15 Peptide.

Amphix Bio has received FDA Orphan Drug Designation for its therapeutic, AMFX-200, which utilizes a new technology platform called Supramolecular Therapeutic Peptides (STPs). These peptides are designed to act as both a drug to activate cell receptors and a physical scaffold to support tissue regeneration, with preclinical studies showing they can help restore motor function after a single injection.

TerSera Therapeutics presented real-world data on prescription patterns for ziconotide (PRIALT®), a non-opioid pain medication derived from a marine snail peptide. The data shows a positive shift in clinical practice toward using ziconotide as a monotherapy and at lower starting doses, aligning with established guidelines for this peptide-based drug.

EndoCyclic Therapeutics was awarded a "Perfect 10" NIH grant for ENDO-205, a non-hormonal therapeutic for endometriosis that uses a novel pH-sensitive peptide mechanism. The therapeutic selectively eliminates lesions at the disease site while leaving healthy tissue untouched, potentially offering the first-ever disease-modifying therapy for endometriosis.

NervGen Pharma's therapeutic peptide, NVG-291-R, a rodent variant of NVG-291, has shown significant functional recovery in preclinical studies of traumatic hearing loss and peripheral nerve injury.The peptide can restore hearing and promote axonal regeneration by targeting nervous system repair.

Merck’s Enlicitide, a macrocyclic peptide that inhibits PCSK9, was effective in reducing LDL cholesterol in adults with hyperlipidemia in Phase 3 trials.

Protagonist Therapeutics announced that its hepcidin-mimetic peptide, Rusfertide, has been granted Breakthrough Therapy Designation by the FDA for the treatment of erythrocytosis in patients with polycythemia vera. The designation was based on positive data from a Phase 3 study, which demonstrated that Rusfertide effectively controlled hematocrit levels, reduced the need for phlebotomy, and improved patient-reported fatigue.

ReAlta Life Sciences was granted Orphan Drug Designation by the European Medicines Agency (EMA) for RLS-0071 (Pegtarazimod), a synthetic peptide, to treat graft-versus-host disease (GvHD). The therapeutic peptide works by inhibiting inflammatory pathways driven by neutrophils which are responsible for the tissue damage that occurs when transplanted immune cells attack the patient.

Rein Therapeutics' lead drug candidate, LTI-03, is a peptide-based therapy for Idiopathic Pulmonary Fibrosis (IPF). Recently published data showed that LTI-03 effectively reduced multiple scarring pathways and lowered collagen production in diseased patient lung tissue without causing cell damage unlike other approved drugs.

Inotrem's drug candidate, Nangibotide, is an immunomodulatory peptide being developed to treat septic shock. The peptide inhibits the TREM-1 pathway, responsible for amplifying the body's inflammatory response. Nanbigotide has shown promise in improving outcomes for high-risk patients.

OPKO Health and Entera Bio announced that their abstract on an oral GLP-2 tablet for treating Short Bowel Syndrome has been selected for the 2025 ESPEN Congress. The new tablet combines a long-acting GLP-2 agonist peptide from OPKO with Entera's N-Tab™ technology to offer a convenient oral alternative to the current daily injectable therapy.

Neurocrine Biosciences has initiated a Phase 1 clinical study for NBIP-01435, a long-acting peptide that acts as a corticotropin-releasing factor type 1 receptor antagonist. The investigational peptide is being developed as a potential treatment for congenital adrenal hyperplasia (CAH), with the goal of improving androgen control and enabling lower glucocorticoid dosing.

In a Phase 1 clinical trial, a new pancreatic cancer vaccine, which uses peptides to train the immune system's T cells to recognize and destroy cancer cells, showed promise in preventing recurrence. The vaccine, which targets the common KRAS gene mutation, led to durable immune responses and longer relapse-free survival in high-risk patients.

ProteinQure announced that it has dosed the first patient in a Phase I clinical trial for its novel peptide therapeutic, PQ203, for patients with advanced metastatic solid tumors. The drug was designed using ProteinQure’s AI platform, and works by targeting the Sortilin receptor. PQ203 has shown promise in preclinical models of Triple Negative Breast Cancer (TNBC).

Greenwich LifeSciences announced that its immunotherapy product, GLSI-100, has received FDA Fast Track designation for treating HER2-positive breast cancer. The product is based on the GP2 peptide, a nine-amino-acid segment of the HER2 protein, which has shown an 80% reduction in metastatic breast cancer recurrence in previous studies.

Avacta's drug, AVA6000, is a peptide drug conjugate designed to be activated specifically within the tumor microenvironment. The data presented at the 2025 ESMO Congress shows that the drug is well-tolerated with fewer side effects than conventional chemotherapy, while also demonstrating promising signs of efficacy, particularly in patients with salivary gland cancers.

Johnson & Johnson has submitted an application for FDA approval of Icotrokinra, a novel oral peptide that selectively blocks the IL-23 receptor to treat plaque psoriasis. In clinical trials, the drug demonstrated superiority to other treatments and a favorable safety profile, with potential to become a new standard of care.

Altimmune has initiated a Phase 2 trial for Pemvidutide, a peptide-based drug that acts as a dual receptor agonist for GLP-1 and glucagon. The trial, called RESTORE, is evaluating the drug's efficacy and safety in treating alcohol-associated liver disease by focusing on its ability to reduce liver stiffness and fat while also promoting weight loss.

In a major win for obesity treatment, the peptide-based dual receptor agonist, Zepbound KwikPen (tirzepatide injection), is now approved and available in Canada. The Zepabound KwikPen uses peptides to activate GIP and GLP-1 hormone receptors, offering a new approach to managing obesity by mimicking the body's natural hunger and satiety signals.

Novo Nordisk's oral semaglutide has received EU approval to reduce cardiovascular death, heart attack, and stroke in people with type 2 diabetes. This marks a significant milestone as it's the first and only oral GLP-1 RA (glucagon-like peptide 1 receptor agonist) to offer this proven cardiovascular benefit.

Novo Nordisk's oral Wegovy is putting a spotlight on the viability of high-dose peptides for drug development. The drug demonstrates that peptides, which typically break down in the stomach, can be delivered orally through the use of an absorption enhancer, paving the way for more convenient treatments.