A Randomized, Phase 3, Double-blind, Double-dummy, Active Comparator-controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Linaprazan Glurate Compared to Lansoprazole in Maintenance of Healing in Participants With Healed Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD) of Los Angeles (LA) Grades A to D

The goal of this clinical trial is to investigate how well linaprazan glurate can maintain healed erosive esophagitis (EE) caused by GERD in participants who have participated in a prior healing trial, compared to lansoprazole (an approved treatment for GERD). Researchers will also examine:
* the effect of linaprazan glurate on heartburn symptoms compared to lansoprazole.
* whether linaprazan glurate treatment is safe and tolerable, based on symptoms and procedures such as blood and urine tests, endoscopy, and electrocardiograms (measure the heart's electrical activity). Endoscopy means that the doctor will insert a thin, flexible tube with a camera down the throat to look at each participant's esophagus area and collect small tissue samples (called biopsies).
* the side effects that may happen during treatment with linaprazan glurate.
Participants must be between 18 to 80 years old and have participated in a prior healing trial with healed EE (due to GERD) confirmed by an endoscopy either from the prior healing trial or from the initial period of this trial. Participants cannot participate if they are not healed, had to stop trial treatment because of a side effect in a prior healing trial, or if they have a condition that could make it unsafe.
The study is a randomized, double-blind, active comparator-controlled clinical trial lasting for almost 14 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups:
* Linaprazan glurate - High dose
* Linaparazan glurate - Low dose, and
* Lansoprazole - marketed approved dose Everyone will take a total of 2 tablets and 1 capsule orally every day for up to 52 weeks. The tablets and capsule will be separated into a morning dose and an evening dose. Some tablets or capsules will be placebos (look like medicine but contain no active drug).
Participants will complete several questionnaires on an electronic device during treatment. An endoscopy will be performed after 24 weeks of treatment to determine if healing has been maintained. If healing has been maintained, the participant will continue taking trial treatment and another endoscopy will be performed at 52 weeks. If healing has not been maintained at 24 weeks or if the participant has reached 52 weeks, the participant will stop taking trial treatment and return for a follow up visit.

Start Date01 Mar 2026

Sponsor / Collaborator

Cinclus Pharma Holding AB

CTR20254718

/ RecruitingPhase 3

多中心、随机、双盲双模拟、阳性药平行对照的Ⅲ期临床研究评价X842胶囊用于十二指肠溃疡患者的有效性和安全性

[Translation] A multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled phase III clinical trial was conducted to evaluate the efficacy and safety of X842 capsules in patients with duodenal ulcers.

主要目的：评价X842胶囊每日1次50mg连续给药4到6周对十二指肠溃疡的内镜下溃疡愈合的有效性，以验证X842胶囊在6周内的内镜下溃疡愈合受试者比例非劣效于兰索拉唑肠溶胶囊；次要目的：与兰索拉唑肠溶胶囊相比，评价X842胶囊改善十二指肠溃疡受试者的临床症状（上腹疼痛、胃烧灼感、反酸、恶心、呕吐、嗳气和腹胀）的有效性；与兰索拉唑肠溶胶囊相比，评价X842胶囊治疗十二指肠溃疡的安全性；观察X842胶囊用于十二指肠溃疡患者后血清胃泌素的治疗前后变化情况。

[Translation]

Primary objective: To evaluate the efficacy of X842 capsules at a dose of 50 mg once daily for 4 to 6 weeks in promoting endoscopic ulcer healing of duodenal ulcers, verifying that X842 capsules were non-inferior to lansoprazole enteric-coated capsules in the proportion of subjects with endoscopic ulcer healing within 6 weeks. Secondary objectives: To evaluate the efficacy of X842 capsules in improving clinical symptoms (upper abdominal pain, heartburn, acid reflux, nausea, vomiting, belching, and abdominal distension) in subjects with duodenal ulcers compared to lansoprazole enteric-coated capsules; to evaluate the safety of X842 capsules in treating duodenal ulcers compared to lansoprazole enteric-coated capsules; and to observe changes in serum gastrin levels before and after treatment with X842 capsules in patients with duodenal ulcers.

Start Date17 Dec 2025

Sponsor / Collaborator

Shanghai Sinorda Pharmaceutical Technology Co., Ltd.

[+1]

CTIS2024-518194-34-00

/ CompletedPhase 1

An open, single arm, single-center, Phase 1 trial investigating the effect of 7-days-repeated administration of linaprazan glurate on the pharmacokinetics of repeated doses of an approved antibiotic in healthy participants

Start Date11 Nov 2025

Sponsor / Collaborator

Cinclus Pharma Holding AB

100 Clinical Results associated with Linaprazan glurate

100 Translational Medicine associated with Linaprazan glurate

100 Patents (Medical) associated with Linaprazan glurate

Literatures (Medical) associated with Linaprazan glurate

01 May 2025·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Clinical Trial: Dose‐Finding Study of Linaprazan Glurate, A Novel Potassium‐Competitive Acid Blocker, Versus Lansoprazole for the Treatment of Erosive Oesophagitis

Article

Author: Unge, Peter ; Andersson, Kjell ; Popadiyn, Ivan ; Rosenholm, Maria ; Yektaei, Elham ; Vaezi, Michael ; Sharma, Prateek ; Larsson, Kajsa ; Armstrong, David ; Rosztóczy, Andras

ABSTRACT:

Background:

Linaprazan glurate, a potassium‐competitive acid blocker, is in development for the treatment of erosive oesophagitis and other acid‐related diseases.

Aim:

To evaluate the 4‐week healing rate and safety of four linaprazan glurate dosing regimens in patients with erosive oesophagitis.

Methods:

This double‐blind, dose‐finding study compared linaprazan glurate to lansoprazole. We included patients with endoscopically confirmed erosive oesophagitis (validated by a central review board) if they had Los Angeles (LA) grade C/D or LA grade A/B with partial response to at least 8 weeks of proton pump inhibitor therapy. Patients were randomised to 4 weeks of linaprazan glurate (25, 50, 75 or 100 mg twice daily) or lansoprazole (30 mg once daily), followed by 4 weeks of open‐label lansoprazole.

Results:

Of 248 patients randomised, central review confirmed erosive oesophagitis in 182 at screening endoscopy. Across all doses, linaprazan glurate achieved a 4‐week healing rate of 71.1% in intention‐to‐treat (ITT) analysis and 80.9% in per protocol (PP) analysis. In comparison, lansoprazole achieved healing rates of 60.6% (ITT) and 59.1% (PPS). The best performing linaprazan glurate dosing group outperformed lansoprazole by 28% in patients with LA grade A/B with partial PPI response and by more than 50% in patients with LA grade C/D.

Conclusions:

Linaprazan glurate demonstrated high 4‐week healing rates compared to lansoprazole, with a good safety profile, supporting its further development.

Trial Registration:

ClinicalTrials.gov: NCT05055128; EudraCT: 2020‐003319‐91

01 Nov 2024·Current gastroenterology reports

Potassium-competitive Acid Blockers: Current Clinical Use and Future Developments

Review

Author: Scarpignato, Carmelo ; Hunt, Richard H

Abstract:

Purpose of the Review:

Acid suppression with proton pump inhibitors (PPIs) represents the standard of care in the treatment of acid-related diseases. However, despite their effectiveness, PPIs display some intrinsic limitations, which underlie the unmet clinical needs that have been identified over the past decades. The aims of this review are to summarize the current status and future development of the new class of antisecretory drugs (potassium-competitive acid blockers, P-CABs) that have recently been introduced into medical practice.

Recent Findings:

Over the past decades, clinical needs unmet by the current acid suppressants have been recognized, especially in the management of patients with GERD, Helicobacter pylori infection and NSAID-related peptic ulcer. The failure to address these needs is mainly due to their inability to achieve a consistent acid suppression in all patients and, particularly, to control nighttime acidity. It was then realized that an extended duration of acid suppression would exert additional benefits. The available data with P-CABs show that they are able to address these unmet clinical needs.

Summary:

Four different P-CABs (vonoprazan, tegoprazan, fexuprazan and keverprazan) are currently available. However, only two of them are approved outside Asia. Vonoprazan is available in North, Central and South America while tegoprazan is marketed only in Latin American countries. Two other compounds (namely linazapran glurate and zestaprazan) are presently under clinical development. While clinical trials on GERD have been performed with all P-CABs, only vonoprazan and tegoprazan have been investigated as components of Helicobacter pylori eradication regimens. The available data show that—in the above two clinical indications—P-CABs provide similar or better efficacy in comparison with PPIs. Their safety in the short-term overlaps that of PPIs, but data from long-term treatment are needed.

01 May 2024·Journal of pharmaceutical and biomedical analysis

Absorption, distribution, metabolism and excretion of linaprazan glurate in rats

Article

Author: Jin Xiu ; Ying Yang ; Donghui Liu ; Ming Lu ; Xingxing Diao ; Chen Yang ; Xinyue Zhang ; Yali Yuan ; Yuandong Zheng ; Pingsheng Hu

Linaprazan (AZD0865, TX07) is one of potassium-competitive acid blockers. However, linaprazan is rapidly excreted from the body, shortening its acid inhibition property. Linaprazan glurate (X842) is a prodrug of linaprazan with a prolonged inhibitory effect on gastric acid secretion. Linaprazan glurate has entered clinical trials, but few studies have reported its metabolism in non-clinical and clinical settings. In this study, we studied the pharmacokinetics, tissue distribution, mass balance, and metabolism of linaprazan glurate in rats after a single oral dose of 2.4 mg/kg (100 µCi/kg) [¹⁴C]linaprazan glurate. The results demonstrated that linaprazan glurate was mainly excreted via feces in rats with 70.48% of the dose over 168 h. The plasma AUC₀_-_∞ of linaprazan glurate in female rats was 2 times higher than that in male rats. Drug-related substances were mainly concentrated in the stomach, eyes, liver, small intestine, and large intestine after administration. In blood, drug-related substances were mostly distributed into plasma instead of hemocytes. In total, 13 metabolites were detected in rat plasma, urine, feces, and bile. M150 (2,6-dimethylbenzoic acid) was the predominant metabolite in plasma, accounting for 80.65% and 67.65% of AUC_0-24_h in male and female rats, respectively. Based on the structures, linaprazan glurate was mainly hydrolyzed into linaprazan, followed by a series of oxidation, dehydrogenation, and glucuronidation in rats. Besides, CES2 is the main metabolic enzyme involved in the hydrolysis of linaprazan glurate to linaprazan.

News (Medical) associated with Linaprazan glurate

18 Feb 2026

·cincluspharma.com

Year-end report – Advancing toward Phase III readout

“The past year was marked by significant progress for Cinclus Pharma. Our first Phase III study has had a promising start, and we expect to present topline results during the second half of the year. The strategic licensing agreement with Zentiva provides a strong platform for successful commercialization in Europe and lays a solid foundation for expansion into other markets. Following the inclusion of linaprazan glurate on China’s national reimbursement list, our Chinese partner plans to launch the product on the market in 2026. With superior acid control compared to existing treatment options, linaprazan glurate has the potential to meet the substantial medical need among patients suffering from the more severe forms of erosive GERD, which we aim to confirm in the ongoing Phase III study”, says Christer Ahlberg CEO of Cinclus Pharma. “The past year was marked by significant progress for Cinclus Pharma. Our first Phase III study has had a promising start, and we expect to present topline results during the second half of the year. The strategic licensing agreement with Zentiva provides a strong platform for successful commercialization in Europe and lays a solid foundation for expansion into other markets. Following the inclusion of linaprazan glurate on China’s national reimbursement list, our Chinese partner plans to launch the product on the market in 2026. With superior acid control compared to existing treatment options, linaprazan glurate has the potential to meet the substantial medical need among patients suffering from the more severe forms of erosive GERD, which we aim to confirm in the ongoing Phase III study”, says Christer Ahlberg CEO of Cinclus Pharma. Financial summary, October-December 2025 » Net sales amounted to TSEK 13,632 (4,580). » Operating income/loss (EBIT) amounted to TSEK -62,011 (-56,889). » Net income/loss for the period was TSEK -61,184 (-54,259) and earnings/loss per share before and after dilution were SEK -1.31 (-1.17). » Total cash flow for the period amounted to TSEK -50,814 (-79,197). » Cash and cash equivalents at the end of the period amounted to TSEK 487,254 (566,716). Financial summary, January-December 2025 » Net sales amounted to TSEK 57,470 (4,580). » Operating income/loss (EBIT) amounted to TSEK -199,558 (-169,639). » Net income/loss for the period was TSEK -183,972 (-168,031) and earnings/loss per share before and after dilution were SEK -3.95 (-4.54). » Total cash flow for the period amounted to TSEK -77,836 (476,833). » Cash and cash equivalents at the end of the period amounted to TSEK 487,254 (566,716). Significant events during the period October-December 2025 Financial summary, October-December 2025 Financial summary, January-December 2025 Significant events during the period October-December 2025 » In early October, it was announced that the first patient had been dosed in the company’s Phase III study, HEEALING 1, which aims to confirm the efficacy of linaprazan glurate in patients with erosive gastroesophageal reflux disease. » In the beginning of October Cinclus Pharma presented an abstract on linaprazan glurate at the United European Gastroenterology Week (UEGW) in Berlin. The abstract highlights positive data on the optimized tablet formulation developed for Phase III studies and future commercialization. » In October Cinclus Pharma received positive feedback from a recent Chemistry, Manufacturing and Controls (CMC) meeting with the FDA. During the meeting, the FDA provided clear guidance and alignment with the company’s proposed CMC strategy preparation for the upcoming new drug application (NDA) submission. » Cinclus Pharma announced in November that it had sponsored a scientific abstract highlighting the clinical and economic costs of PPI treatment failures in patients with severe erosive GERD. The abstract was presented at the ISPOR Europe 2025 conference in Glasgow. » Cinclus Pharma hosted a virtual event to share insights on clinical practice for erosive Gastroesophageal Reflux Disease (GERD) patients in December. The event featured Professor Prateek Sharma from the Cancer Center in Kansas City who provided insights on the current treatment landscape and the unmet medical need among patients with erosive GERD, as well as the potential of Cinclus Pharma’s drug candidate linaprazan glurate. » Cinclus Pharma has recruited Magnus Christensen as CFO. He will assume his new role in the spring of 2026. » Linaprazan glurate earns China’s National Reimbursement Listing for the treatment of erosive GERD. This enables broad patient access, and the product is now expected to be launched on the Chinese market in 2026. Significant events after the end of the period Significant events after the end of the period » At an Extraordinary General Meeting on 19 January, Kjell Andersson was elected as a new board member after Peter Unge had announced his wish to step down from his position on the company’s board. » In January, Cinclus Pharma announced that the European Medicines Agency (EMA) has provided positive feedback following scientific advice regarding Chemistry, Manufacturing and Controls (CMC) for linaprazan glurate. » In February, FDA provided a positive assessment of Cinclus Pharma’s nonclincial development plan for linaprazan glurate following a scientific advice meeting. Presentation of the interim report A webcast will be held on February 18, 2026, at 10:00 CET via Inderes. If you wish to participate via webcast please use the link below. Via the webcast you are able to ask written questions. https://cinclus-pharma.events.inderes.com/q4-report-2025 If you wish to participate via teleconference please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference. https://events.inderes.com/cinclus-pharma/q4-report-2025/dial-in Presentation of the interim report For additional information, please contact: For additional information, please contact: Christer Ahlberg, CEO Phone: +46 70 675 33 30 e-mail: christer.ahlberg@cincluspharma.com Henrik Vikström, IR Phone: +46 70 952 80 06 e-mail: henrik.vikström@cincluspharma.com About Cinclus Pharma About Cinclus Pharma Cinclus Pharma Holding AB (publ) is a late-stage clinical pharmaceutical company developing drugs for the treatment of acid-related diseases and disorders of the upper gastrointestinal tract. The company's leading drug candidate is linaprazan glurate, a prodrug of P-CAB linaprazan, which was originally developed by AstraZeneca. Linaprazan glurate has the potential to heal erosions in the esophageal mucosa and relieve symptoms of gastroesophageal reflux disease (GERD) more effectively than current treatments like proton pump inhibitors (PPI). The safety and efficacy of linaprazan and linaprazan glurate have been documented in over 30 phase I and two phase II studies involving more than 3,000 participants. The first Phase III study commenced in 2025. GERD affects approximately 133 million adults in the US and EU, and there is a significant need for new drugs to treat the most severe cases: around 10 million patients. Linaprazan glurate is developed to meet these needs. For more information, visit www.cincluspharma.com. Attachments Attachments Year End Report 2025

Phase 3License out/inPhase 2Executive ChangeFinancial Statement

16 Jun 2025

·cincluspharma.com

Cinclus Pharma secures EMA and FDA pediatric study waivers for linaprazan glurate in H. pylori infection

Cinclus Pharma AB (publ), a clinical-stage pharmaceutical company developing next generation treatments for acid-related diseases, today announced that the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have granted exemption from the requirement to conduct pediatric studies with linaprazan glurate for the treatment of Helicobacter pylori (H. pylori) infection. In addition to treating eGERD, linaprazan glurate can in combination with antibiotics potentially be used to treat infections caused by H. pylori, a bacterium found in the stomach. H. pylori infection is a globally prevalent bacterial infection that affects more than half of the world’s population and is associated with gastritis, ulcers and gastric cancer. The WHO lists H. pylori as one of the antibiotic-resistant bacteria that poses the greatest threat to human health. Today, H. pylori infection is treated with acid-inhibiting drugs in combination with two or three antibacterial agents. Antibiotic resistance in these treatments is high and increasing, which is seen as a major problem. Cinclus Pharma’s linaprazan glurate, with its unique acid control properties, has potential to be at least as effective or better than current standard treatments while requiring only a single narrow spectrum antibiotic - thereby reducing the antibiotic use and the risk of resistance. The EMA and FDA waivers remove all requirements for pediatric studies, which would otherwise have been mandatory to obtain market approval in the EU and the US respectively for the treatment of H. pylori infection. "These regulatory waivers represent a meaningful milestone for Cinclus Pharma, streamlining the potential development of linaprazan glurate in H. pylori and enabling us to pursue this significant market opportunity more efficiently. With a differentiated profile and reduced reliance on antibiotics, linaprazan glurate has the potential to redefine the treatment paradigm for H. pylori infection. A potential approval for H. pylori infection would extend the data exclusivity of linaprazan glurate from 5 to 10 years in the US and from 10 to 11 years in Europe.", says Christer Ahlberg, CEO of Cinclus Pharma. Cinclus Pharma has full global commercial rights outside China for linaprazan glurate for the treatment of H. pylori as this indication was not part of the recently announced agreement with Zentiva for the commercialization and manufacture of linaprazan glurate on the European market. For additional information, please contact: Christer Ahlberg, CEO Phone: +46 70 675 33 30 e-mail: christer.ahlberg@cincluspharma.com Henrik Vikström, IR Phone: +46 70 952 80 06 e-mail: henrik.vikström@cincluspharma.com About Cinclus Pharma Cinclus Pharma Holding AB (publ) is a late-stage clinical pharmaceutical company developing drugs for the treatment of acid-related diseases and disorders of the upper gastrointestinal tract. The company's leading drug candidate is linaprazan glurate, a prodrug of P-CAB linaprazan, which was originally developed by AstraZeneca. Linaprazan glurate has the potential to heal erosions in the esophageal mucosa and relieve symptoms of gastroesophageal reflux disease (GERD) more effectively than current treatments like proton pump inhibitors (PPI). The safety and efficacy of linaprazan and linaprazan glurate have been documented in over 30 phase I and two phase II studies involving more than 3,000 participants. Planning for phase III studies is currently underway, with an expected start in 2025. GERD affects approximately 133 million adults in the US and EU, and there is a significant need for new drugs to treat the most severe cases: around 10 million patients. Linaprazan glurate is developed to meet these needs. For more information, visit www.cincluspharma.com. Attachments Cinclus Pharma secures EMA and FDA pediatric study waivers for linaprazan glurate in H. pylori infection

License out/inPhase 2Phase 1

22 May 2025

·www.fiercepharma.com

Zentiva inks €220M deal to commercialize AstraZeneca GI cast-off in Europe

Cinclus Pharma was founded in 2014 by a group of former AstraZeneca employees who wanted to take linaprazan further. Former Sanofi subsidiary Zentiva has signed off on up to 220 million euros for the rights to commercialize and manufacture an ex-AstraZeneca asset for gastric-acid-related diseases in Europe.Under the terms of the deal, Zentiva is paying Cinclus Pharma 13 million euros upfront, with a near-term milestone payment of 5 million euros to follow next year, according to a May 22 release. The total possible value of the agreement, at 220 million euros, includes the upfront payment and all commercial and regulatory milestones. In return, Zentiva has secured the rights to commercialize and manufacture linaprazan glurate in Europe. Cinclus can also receive tiered double-digit royalties on net sales in Europe. The partnership applies to the U.K., Switzerland and all the countries in the European Economic Area.“This alliance establishes a fully integrated set of capabilities covering everything necessary to bring linaprazan glurate to the market across Europe,” Cinclus CEO Christer Ahlberg said in the release. “This collaboration not only de-risks our path to European approval but also positions us to capture significant global value, particularly in the U.S. market where we retain full commercial rights and see a substantial commercial opportunity.”Linaprazan glurate is a potassium-competitive acid blocker that Cinclus is developing for severe erosive gastroesophageal reflux disease (eGERD). Cinclus, which is based in Sweden, plans to test the asset in a phase 3 trial starting in the third quarter of this year.Linaprazan glurate was approved by Chinese regulators as a GERD treatment in December 2024, and Cinclus has previously set out plans to launch the drug itself in China this year. eGERD occurs when stomach acid backs up into the esophagus, damaging the gastric tube’s lining. The condition can cause heartburn, trouble swallowing and chest pain, among other symptoms.Linaprazan was initially developed by AstraZeneca and tested in phase 1 and 2 trials between 2001 and 2005, according to Cinclus’ website. Cinclus was founded in 2014 by a group of former AstraZeneca employees who wanted to take the molecule further after the Big Pharma lost interest in the drug.Cinclus unveiled data from a phase 2 dose-selection study of linaprazan in November 2022. The study compared linaprazan with over-the-counter competitor lansoprazole but was not statistically powered to test whether there was a significant difference between the two, Cinclus said at the time. A post hoc analysis of the data found that eGERD patients treated with linaprazan glurate had higher rates of healing, as assessed by an endoscopic evaluation, than those given lansoprazole, Cinclus said.Zentiva also has a history with Big Pharma; the Czech drugmaker was a subsidiary of Sanofi from 2008 to 2018, with a focus on generics. Zentiva was acquired by private equity firm Advent International in 2018 and is now taking a turn into brand-name products.“This partnership marks a key milestone for Zentiva as we continue expanding our portfolio beyond generics into high-value specialty medicines,” Zentiva Chief Scientific Officer Martin Albert said in the release. “Linaprazan glurate is a complementary asset that perfectly fits our strategy to leverage our excellence in generics and deliver game-changing treatments to patients across Europe.”

Drug ApprovalPhase 1License out/inPhase 2Acquisition

100 Deals associated with Linaprazan glurate

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Esophagitis, Peptic	China	Shanghai Sinorda Pharmaceutical Technology Co., Ltd.	01 Dec 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Esophagitis	Phase 3	-	Cinclus Pharma Holding AB	01 Mar 2026
Helicobacter pylori infection	Phase 3	China	Shanghai STA Pharmaceutical PRODUCT Co., Ltd.	21 Jan 2026
Helicobacter pylori infection	Phase 3	China	Shanghai Sinorda Pharmaceutical Technology Co., Ltd.	21 Jan 2026
Duodenal Ulcer	Phase 3	China	Shanghai Sinorda Pharmaceutical Technology Co., Ltd.	17 Dec 2025
Erosive esophagitis	Phase 3	United States	Cinclus Pharma Holding AB	03 Oct 2025
Erosive esophagitis	Phase 3	Bulgaria	Cinclus Pharma Holding AB	03 Oct 2025
Erosive esophagitis	Phase 3	Czechia	Cinclus Pharma Holding AB	03 Oct 2025
Erosive esophagitis	Phase 3	Germany	Cinclus Pharma Holding AB	03 Oct 2025
Erosive esophagitis	Phase 3	Hungary	Cinclus Pharma Holding AB	03 Oct 2025
Erosive esophagitis	Phase 3	Poland	Cinclus Pharma Holding AB	03 Oct 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05742984 (CTgov)	Phase 1	Gastroesophageal Reflux	75	Linaprazan Glurate (25 mg Linaprazan Glurate QD)	gjtzrjojmb(pepxvnfsnc) = khrzbvjbls krtnavlaju (ghuoizjllu, 1650.6) View more	-	07 May 2025
				Linaprazan Glurate (50 mg Linaprazan Glurate QD)	gjtzrjojmb(pepxvnfsnc) = ohnhyekyzh krtnavlaju (ghuoizjllu, 2281.0) View more
NCT05055128 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 2	Erosive esophagitis	248	Linaprazan Glurate	tvqydfroij(strlddrfoi) = yayiuuzyfe kfbegqnonc (lfhhbuevqt ) View more	Positive	04 Apr 2025
				Lansoprazole	tvqydfroij(strlddrfoi) = vzeqfjordb kfbegqnonc (lfhhbuevqt ) View more
NCT05627518 (BA, CTgov)	Phase 1	-	67	Linaprazan glurate (Reference Formulation (Treatment A))	oqjnqexops(ubutmmwbvl) = afgaoraner klrjvwjhyn (iwsdjwpdcm, 1.51) View more	-	03 Apr 2025
				Linaprazan glurate (Test Formulation (Treatment B))	oqjnqexops(ubutmmwbvl) = pynfsrzssr klrjvwjhyn (iwsdjwpdcm, 1.32) View more
NCT04531475 (Phase 2 study, Pubmed \| Clin Transl Gastroenterol)	Phase 2	Erosive esophagitis	90	X842 50 mg	ueoevzfref(trnzjurhaq) = The incidence of drug-related treatment-emergent adverse events did not differ among groups zkhtkqjhwt (kvxwrnyqpx ) View more	Positive	01 Apr 2025
				X842 100 mg
NCT05633147 (CTgov)	Phase 1	Medication interactions	35	Linaprazan glurate+Clarithromycin (Part I)	slxeseaxsr(mlwdmnhdfv) = nevnfmppla dffmwzfqqs (vyhuatcoos, 5649) View more	-	03 Jan 2025
				Midazolam+Linaprazan glurate hydrochloride (HCl) (Part II)	dxtkgoxvnm(yeclhjxhta) = lzqcxsmhux btxicadkgg (llxrqcvssg, 13.98) View more
NCT05055128 (CTgov)	Phase 2	Erosive esophagitis \| Gastroesophageal Reflux	248	Lansoprazole+X842 Dummy (X842 25 mg BID)	tgulaafqey = ruuozdqlwg fsyocpxolk (sspyanotla, ceyrorxbve - ipihaubiem) View more	-	01 Nov 2023
				Lansoprazole+X842 Dummy (X842 50 mg BID)	tgulaafqey = mesrbtjmqa fsyocpxolk (sspyanotla, hgembjhrzh - mnyzkngmim) View more
UEGW2023	Not Applicable	-	-	Linaprazan glurate 25 mg BID	enqcimhnhs(gbwhdkhtha) = gmaziqtean ynjzjxnubu (zvchmkrxek, 59.7 - 84.7)	-	15 Oct 2023
				Linaprazan glurate 50 mg BID	enqcimhnhs(gbwhdkhtha) = fwkzhkbvju ynjzjxnubu (zvchmkrxek, 73.8 - 91.1)

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Clinical Trial

Approval

Regulation