linaprazan glurate (X842) / Cinclus Pharma, Jiangsu Sinorda Biomedicine - LARVOL DELTA

A Single-arm, Prospective Real-world Study of Linaprazan Glurate Capsules in the Treatment of Reflux Esophagitis (ChiCTR) - P=N/A | N=400 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Kunming Medical University; The First Affiliated Hospital of Kunming Medical University

New trial • Real-world evidence • Gastrointestinal Disorder

A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) (clinicaltrials.gov) - P3 | N=500 | Active, not recruiting | Sponsor: Cinclus Pharma Holding AB | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate (clinicaltrials.gov) - P1 | N=121 | Recruiting | Sponsor: Cinclus Pharma Holding AB | Unknown status ➔ Recruiting | Trial completion date: Dec 2024 ➔ Nov 2026 | Trial primary completion date: Dec 2024 ➔ Nov 2026

Enrollment open • Trial completion date • Trial primary completion date • Gastroesophageal Reflux Disease

A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) (clinicaltrials.gov) - P3 | N=500 | Recruiting | Sponsor: Cinclus Pharma Holding AB | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Maintenance of Healing in Participants With Healed Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Cinclus Pharma Holding AB | N=1050 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Cinclus Pharma Holding AB

Trial initiation date • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

CX842A2303: A randomized, phase 3 multicenter clinical trial to confirm the clinical efficacy and evaluate the safety of linaprazan glurate compared to lansoprazole in participants with healed erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) (clinicaltrialsregister.eu) - P2/3 | N=12 | Not yet recruiting | Sponsor: Cinclus Pharma Holding AB (publ)

New P2/3 trial • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

CX842A2301: A randomized, phase 3 multicenter study to confirm the clinical efficacy of linaprazan glurate compared to lansoprazole in participants with erosive esophagitis (EE) due to gastroesophageal reflux disease (GERD) (clinicaltrialsregister.eu) - P2/3 | N=382 | Recruiting | Sponsor: Cinclus Pharma Holding AB (publ)

New P2/3 trial • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

A Study to Investigate the Effect of Linaprazan Glurate on the Pharmacokinetics of Amoxicillin (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Cinclus Pharma Holding AB | Recruiting ➔ Completed

Trial completion • Gastroenterology • Gastroesophageal Reflux Disease

Drug Interaction Study on Linaprazan Glurate Capsules (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Jiangsu Sinorda Biomedicine Co., Ltd | Recruiting ➔ Completed

Trial completion

A Randomized, Phase 3 Multicenter Clinical Trial to Confirm the Clinical Efficacy and Evaluate the Safety of Linaprazan Glurate Compared to Lansoprazole in Participants With Healed Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) (clinicaltrials.gov) - P3 | N=1050 | Not yet recruiting | Sponsor: Cinclus Pharma Holding AB

New P3 trial • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

A Study to Investigate the Effect of Linaprazan Glurate on the Pharmacokinetics of Amoxicillin (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Cinclus Pharma Holding AB

New P1 trial • Gastroenterology • Gastroesophageal Reflux Disease

Drug Interaction Study on Linaprazan Glurate Capsules (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Jiangsu Sinorda Biomedicine Co., Ltd

New P1 trial

OPTIMISED BIOPHARMACEUTICAL AND PHARMACOKINETIC PROPERTIES OF A LINAPRAZAN GLURATE TABLET FORMULATION TO BE USED IN PHASE 3 (UEGW 2025) - "An optimized linaprazan glurate HCl tablet formulation has been developed for Phase 3, with a later tmax and an approximately 2-fold higher bioavailability than the initial tablet and only a minor impact of food intake on linaprazan AUCinf. In addition, the linaprazan glurate HCl tablet provided dose-proportional increase in linaprazan plasma exposure as reflected by AUC and Cmax."

P3 data • PK/PD data • Gastrointestinal Disorder

Pharmacological characterization of linaprazan glurate (X842), a novel potassium-competitive acid blocker, in vitro and in vivo. (PubMed, Front Pharmacol) - "Linaprazan, X842, and vonoprazan selectively inhibited acid formation from gastric H+/K+-ATPase in a potassium-dependent manner. X842 is a prodrug that exerts pharmacological effects both independently and through its metabolized active compound linaprazan, with both a fast onset and a long duration of action. X842 could be a potential drug candidate worthy of further clinical study."

Journal • Preclinical

The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis (clinicaltrials.gov) - P3 | N=380 | Completed | Sponsor: Jiangsu Sinorda Biomedicine Co., Ltd

New P3 trial • Gastrointestinal Disorder • GAST

Mass Balance Study of [14C]X842 in Healthy Adult Male Subjects (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Jiangsu Sinorda Biomedicine Co., Ltd

New P1 trial • Gastroenterology • Gastroesophageal Reflux Disease

Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis (clinicaltrials.gov) - P2 | N=90 | Completed | Sponsor: Jiangsu Sinorda Biomedicine Co., Ltd | Recruiting ➔ Completed

Trial completion • Gastrointestinal Disorder • GAST

A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) (clinicaltrials.gov) - P3 | N=500 | Not yet recruiting | Sponsor: Cinclus Pharma Holding AB

New P3 trial • Gastroenterology • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

OPTIMISED BIOPHARMACEUTICAL AND PHARMACOKINETIC PROPERTIES OF A LINAPRAZAN GLURATE TABLET FORMULATION TO BE USED IN PHASE 3 STUDIES (DDW 2025) - "An optimized linaprazan glurate HCl tablet formulation has been developed for Phase 3, with a later t max and an approximately 2-fold higher bioavailability than the initial tablet and only a minor impact of food intake on linaprazan AUC inf . In addition, the linaprazan glurate HCl tablet provided dose-proportional increase in linaprazan plasma exposure as reflected by AUC and C max . Reference: Flezar M et al."

P3 data • PK/PD data

PHARMACOKINETICS AND PHARMACODYNAMICS OF LINAPRAZAN GLURATE AFTER MULTIPLE ORAL DOSES UP TO 14 DAYS IN HEALTHY SUBJECTS (DDW 2025) - "The PK and PD properties of LG indicate a strong clinical efficacy potential in patients with acid related disease to be confirmed in a phase 3 program. A rapid onset of effect was observed in all dosing groups, with sustained maintenance of pH>4 in all subjects and a pH>5 HTR exceeding 80% at steady state in the two highest dosing groups. Repeated oral doses of LG at 25, 50, and 75 mg QD and BID over 14 days were safe and well-tolerated."

Clinical • PK/PD data

Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects (clinicaltrials.gov) - P1 | N=75 | Completed | Sponsor: Cinclus Pharma Holding AB | Active, not recruiting ➔ Completed

Trial completion • Gastroesophageal Reflux Disease

Clinical Trial: Dose-Finding Study of Linaprazan Glurate, A Novel Potassium-Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis. (PubMed, Aliment Pharmacol Ther) - P2 | "Linaprazan glurate demonstrated high 4-week healing rates compared to lansoprazole, with a good safety profile, supporting its further development."

Journal • Gastroesophageal Reflux Disease • Gastrointestinal Disorder

A Randomized, Comparative Trial of a Potassium-Competitive Acid Blocker (X842) and Lansoprazole for the Treatment of Patients with Erosive Esophagitis. (PubMed, Clin Transl Gastroenterol) - "Our findings confirmed that X842 had efficacy and a favourable safety profile similar to those of lansoprazole. Therefore, X842, a novel P-CAB, is expected to become a promising therapeutic agent for EE."

Journal • Gastrointestinal Disorder

PHARMACOKINETICS AND PHARMACODYNAMICS OF LINAPRAZAN GLURATE AFTER MULTIPLE ORAL DOSES UP TO 14 DAYS IN HEALTHY SUBJECTS (UEGW 2024) - "A rapid onset of pH>4 HTR was seen with LG with a clear dose response. The two highest dosing groups achieved above 90% pH>4 HTR excluding the initial 90 min after the first dose.Repeated oral doses of LG 25, 50 and 75 mg QD and BID for 14 days were safe and well tolerated."

Clinical • PK/PD data • Gastroenterology • Pain