Phase 1 HCXT-2001, an oral macrocyclic IL-23R peptide, could be paired with emvistegrast as a daily oral IBD treatment, according to Gilead.
Gilead Sciences announced on October 22, 2026, that it has entered into a definitive
"HCXT-2001 adds a potentially differentiated oral approach to our growing inflammation pipeline, reflecting our commitment to addressing significant unmet patient needs," said
HCXT-2001 targets IL-23R, which Gilead described in its release as a clinically validated target in immune-mediated inflammatory diseases, including inflammatory bowel disease (IBD), with potential applications in psoriasis.1 The program was originally developed by PepStar, a privately held, clinical-stage biotechnology company.1
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Gilead will pay $1.275 billion in upfront cash, subject to customary adjustments, payable at closing. The transaction is subject to customary closing conditions and is expected to close in the fourth quarter of 2026.1 Gilead expects the deal to reduce its generally accepted accounting principles (GAAP) and non-GAAP earnings per share by approximately $0.79 to $0.83 in the fourth quarter of 2026.1
"We are excited for Gilead to take HCXT-2001 forward and believe their scientific expertise and global development capabilities can help realize the full potential of this novel oral IL-23R inhibitor," said
Dr Berger's reference to combination use points to emvistegrast (GS-1427), Gilead's investigational once-daily oral inhibitor of α4β7 integrin. On October 19, 2026, Gilead reported that emvistegrast met the primary end point of a phase 2 study (SWIFT) in 238 adults with moderately to severely active ulcerative colitis.3 At week 12, 66% of patients receiving emvistegrast 200 mg achieved clinical response vs 37% with placebo (nominal p<.001). Gilead plans to begin a phase 3 monotherapy study in 2027.3
Gilead’s inflammation focus areas include IBD, type 2 inflammatory diseases, lupus, and B cell–mediated autoimmune diseases.1
HCXT-2001 enters a class that already includes an approved product. In March 2026, FDA approved Johnson & Johnson's icotrokinra (Icotyde), an oral peptide IL-23R antagonist, for moderate to severe plaque psoriasis in adults and pediatric patients 12 years and older.4 Icotrokinra is also being studied in moderately to severely active ulcerative colitis and Crohn's disease in the ICONIC-UC and ICONIC-CD trials.4
HCXT-2001 is in phase 1 testing, and its safety and efficacy have not been established. It has not yet been approved by any regulatory authority.1 Neither company disclosed clinical data for the program, and the registered phase 1 study enrolls healthy adults rather than patients with IBD.2 The deal has not yet closed. Combination use with emvistegrast is a stated potential, not a tested regimen, and the emvistegrast SWIFT results have not been peer reviewed.
