Cinclus Pharma Completes Screening in Phase III HEEALING1 Trial of Linaprazan Glurate

Cinclus Pharma Holding AB has completed screening of patients in the pivotal Phase III HEEALING1 trial evaluating linaprazan glurate in erosive gastroesophageal reflux disease (GERD). The company is on track to deliver topline results in Q4 2026.

Linaprazan glurate is a next-generation potassium-competitive acid blocker (PCAB) and a prodrug of linaprazan, designed to optimize pharmacokinetics by providing sustained acid suppression with lower peak plasma concentrations. In the Phase II LEED study, linaprazan glurate achieved four-week healing rates of up to 93% in patients with moderate to severe erosive GERD, compared with 38% for lansoprazole, a standard proton pump inhibitor (PPI). In patients with only partial response after 8 weeks of PPI treatment, linaprazan glurate showed 100% healing after 4 weeks of treatment in the best dosing group. Standard PPI therapy fails to heal a significant proportion of the most severe patients, representing a substantial unmet medical need in an estimated 19 million patients worldwide.

The HEEALING1 study is a randomized, double-blind trial comparing linaprazan glurate to the current standard of care, a PPI, with a primary focus on superior healing rates, faster healing time, and improved symptom control. The trial enrolls approximately 500 patients in eight European countries and includes an up to eight-week treatment period. The primary endpoint is superiority to lansoprazole in healing of patients with moderate to severe erosive GERD (LA grade C/D) after 4 weeks; secondary endpoints include healing and symptom relief for up to 8 weeks. The second Phase III study, HEEALING2, which will also evaluate maintenance therapy and represents the final study prior to regulatory submission, is planned to commence in both the US and Europe following the HEEALING1 topline results.

The Chief Medical Officer said data from previous preclinical and clinical studies have demonstrated significant potential for linaprazan glurate, and that HEEALING1 is designed to confirm those results in a larger, well-powered patient population. The CEO said HEEALING1 has enrolled on schedule and the upcoming topline readout is a key clinical milestone for the company.

In parallel, Cinclus Pharma is conducting a Phase I trial to investigate the pharmacokinetics and ECG effects of single doses of linaprazan glurate administered as oral tablets to healthy participants. The randomized, double-blind, placebo-controlled study uses quadruple masking and aims to map drug levels, assess heart rhythm effects, and confirm basic safety. The study was first submitted on July 15, 2022, and the latest update was posted on June 15, 2026; it is still listed as recruiting.

The company has also cited strong global partnerships and regulatory progress, supported by a solid cash position and growing licensing revenues, with market momentum for P-CABs remaining robust.