[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 bismuth-containing X842 capsules as a quadruple therapy for eradicating Helicobacter pylori.

主要目的：评价在含铋剂四联疗法中联合 X842 胶囊对比联合艾司奥美拉唑镁肠溶片（耐信®）对所有 Hp阳性（+）受试者进行 Hp 根除治疗的疗效，以验证 X842 胶囊辅助根除 Hp 的疗效非劣效于艾司奥美拉唑镁肠溶片；次要目的：评价在含铋剂四联疗法中联合 X842 胶囊对比联合艾司奥美拉唑镁肠溶片（耐信®）对克拉霉素耐药的 Hp+受试者进行 Hp 根除治疗的疗效；评价在含铋剂四联疗法中联合 X842 胶囊对比联合艾司奥美拉唑镁肠溶片（耐信®）对阿莫西林耐药的 Hp+受试者进行 Hp 根除治疗的疗效；评价含铋剂四联疗法中联合 X842 胶囊对所有 Hp+受试者进行 Hp 根除治疗的安全性。

[Translation]

Primary Objective: To evaluate the efficacy of bismuth-containing quadruple therapy combined with X842 capsules versus combined with esomeprazole magnesium enteric-coated tablets (Nexium®) in all *Helicobacter pylori* (Hp)-positive (+) subjects for *Hp* eradication therapy, to verify that the efficacy of X842 capsules as an adjunct to Hp eradication is non-inferior to that of esomeprazole magnesium enteric-coated tablets; Secondary Objectives: To evaluate the efficacy of bismuth-containing quadruple therapy combined with X842 capsules versus combined with esomeprazole magnesium enteric-coated tablets (Nexium®) in clarithromycin-resistant *Hp*-positive subjects for *Hp* eradication therapy; to evaluate the efficacy of bismuth-containing quadruple therapy combined with X842 capsules versus combined with esomeprazole magnesium enteric-coated tablets (Nexium®) in amoxicillin-resistant *Hp*-positive subjects for *Hp* eradication therapy; to evaluate the safety of bismuth-containing quadruple therapy combined with X842 capsules in all *Hp*-positive subjects for *Hp* eradication therapy.

Start Date11 Mar 2026

Sponsor / Collaborator

Shanghai Sinorda Pharmaceutical Technology Co., Ltd.

[+1]

NCT07313774

/ WithdrawnPhase 3

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

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]

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 ; Donghui Liu ; Ying Yang ; Ming Lu ; Chen Yang ; Xingxing Diao ; 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

13 May 2026

·cincluspharma.com

Interim report January-March 2026 - Phase III study approaching full enrollment

“Patient enrollment in our first Phase III study has continued to progress well and we have good visibility on the timeline with expected topline results in the fourth quarter of this year. The strengthened financial position provides increased flexibility and enables an efficient start to the HEEALING 2 study, the final part of the Phase III program for erosive GERD. During the quarter, Cinclus Pharma also made further regulatory progress toward a future marketing authorization for linaprazan glurate, a drug with the potential to improve quality of life for patients suffering from severe acid related diseases who are not helped by existing treatment options”, said Christer Ahlberg, CEO of Cinclus Pharma. Financial summary, January – March 2026» Net sales amounted to TSEK 10,036 (0).» Operating profit (EBIT) amounted to TSEK -90,854 (-47,519).» The result for the period was TSEK -88,768 (-33,672) and earnings (loss) per share before and after dilution were SEK -1.91 (-0.72) SEK.» Total cash flow for the period amounted to TSEK -12,712 (-42,133).» Cash and cash equivalents at the end of the period amounted to TSEK 475,849 (523,899) Significant events during the period January – March 2026» At an Extraordinary General Meeting on January 19, 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 February, Cinclus Pharma announced that the European Medicines Agency (EMA) had issued a positive opinion following completed scientific advice regarding CMC (Chemistry, Manufacturing and Controls) for linaprazan glurate. » In February, the FDA issued a positive assessment of the company’s preclinical development plan for linaprazan glurate following completed scientific advice. » In February, Cinclus Pharma announced that the FDA had determined that a single pivotal study will become the new standard for market approval of drugs in the US. » In March, Cinclus Pharma announced that a financing agreement of EUR 28 million had been entered into with Claret Capital Partners, enabling an earlier start of the final stage of the Phase III program. The financing is structured as a secured loan facility with warrants and convertible instruments. Significant events after the end of the period» On April 16, Cinclus Pharma’s annual report for 2025 was published, along with the notice convening the Annual General Meeting to be held on May 21, 2026. Presentation of the interim reportA webcast will be held on May 13, 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/q1-report-2026 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/q1-report-2026/dial-in 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. For additional information, please contact: Christer Ahlberg, CEOPhone: +46 70 675 33 30e-mail: christer.ahlberg@cincluspharma.com Henrik Vikström, IRPhone: +46 70 952 80 06e-mail: henrik.vikström@cincluspharma.com Attachments Interim Report January March 2026

Phase 2Financial StatementPhase 3Phase 1Executive Change

29 Apr 2026

·cincluspharma.com

Invitation to presentation of Cinclus Pharma’s first quarter report 2026

Cinclus Pharma’s first quarter report for January – March 2026 will be published on Wednesday, May 13, 2026, at 08:00 am CET. The company will host a live presentation the same day at 10:00 am CET. The report is presented by CEO Christer Ahlberg, CFO Magnus Christensen and R&D Director Margit Mahlapuu. The presentation includes a Q&A session. 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/q1-report-2026 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/q1-report-2026/dial-in The report, the presentation and a recorded version of the presentation will also be available on the company's website:Financial Reports | 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. For additional information, please contact: Christer Ahlberg, CEOPhone: +46 70 675 33 30e-mail: christer.ahlberg@cincluspharma.com Henrik Vikström, IRPhone: +46 70 952 80 06e-mail: henrik.vikström@cincluspharma.com Attachments Invitation to presentation of Cinclus Pharma’s first quarter report 2026

Phase 2Phase 3Phase 1

16 Apr 2026

·cincluspharma.com

Cinclus Pharma publishes its Annual Report for 2025

The Annual Report is available at https://cincluspharma.com/investors/financial-reports/. The Swedish version of the report is also available in European Single Electronic Format (ESEF). “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, Cinclus Pharma.

License out/inPhase 3

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
Helicobacter pylori infection	Phase 3	China	Shanghai STA Pharmaceutical PRODUCT Co., Ltd.	11 Mar 2026
Helicobacter pylori infection	Phase 3	China	Shanghai Sinorda Pharmaceutical Technology Co., Ltd.	11 Mar 2026
Duodenal Ulcer	Phase 3	China	Shanghai Sinorda Pharmaceutical Technology Co., Ltd.	17 Dec 2025
Esophagitis	Phase 3	United States	Cinclus Pharma Holding AB	11 Sep 2025
Esophagitis	Phase 3	Bulgaria	Cinclus Pharma Holding AB	11 Sep 2025
Esophagitis	Phase 3	Czechia	Cinclus Pharma Holding AB	11 Sep 2025
Esophagitis	Phase 3	Germany	Cinclus Pharma Holding AB	11 Sep 2025
Esophagitis	Phase 3	Hungary	Cinclus Pharma Holding AB	11 Sep 2025
Esophagitis	Phase 3	Poland	Cinclus Pharma Holding AB	11 Sep 2025
Esophagitis	Phase 3	Romania	Cinclus Pharma Holding AB	11 Sep 2025

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Indication

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Evaluation

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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)	ccbqcblplr(wqypowsxkb) = huttmdljmi mbczxnsahz (eldrarjbea, 1650.6) View more	-	07 May 2025
				Linaprazan Glurate (50 mg Linaprazan Glurate QD)	ccbqcblplr(wqypowsxkb) = xmngcqsxjc mbczxnsahz (eldrarjbea, 2281.0) View more
NCT05055128 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 2	Erosive esophagitis	248	Linaprazan Glurate	bqlyrtdxvq(krbglqeibm) = vuikxcvhmr vuzftsmmkw (kyjjmjwkux ) View more	Positive	04 Apr 2025
				Lansoprazole	bqlyrtdxvq(krbglqeibm) = bepnxyttlv vuzftsmmkw (kyjjmjwkux ) View more
NCT05627518 (BA, CTgov)	Phase 1	-	67	Linaprazan glurate (Reference Formulation (Treatment A))	naxcusvicy(uqzffupqta) = lwjktwxwiq vymqtwyyah (orvzlmrnlw, 1.51) View more	-	03 Apr 2025
				Linaprazan glurate (Test Formulation (Treatment B))	naxcusvicy(uqzffupqta) = ytcrnqhskp vymqtwyyah (orvzlmrnlw, 1.32) View more
NCT04531475 (Phase 2 study, Pubmed \| Clin Transl Gastroenterol)	Phase 2	Erosive esophagitis	90	X842 50 mg	snsomexcjs(beyjqfahps) = The incidence of drug-related treatment-emergent adverse events did not differ among groups ltefdkxrqz (wwylfisfle ) View more	Positive	01 Apr 2025
				X842 100 mg
NCT05633147 (CTgov)	Phase 1	Medication interactions	35	Linaprazan glurate+Clarithromycin (Part I)	jaykjhabuu(vyrdtltime) = cpkhbpuwnz vrlwfzmspy (ihcmkccgus, 5649) View more	-	03 Jan 2025
				Midazolam+Linaprazan glurate hydrochloride (HCl) (Part II)	ilzrmkmali(tuxfmmpnqc) = olxdfqysig ynyvzgqpvv (frldkimdut, 13.98) View more
NCT05055128 (CTgov)	Phase 2	Erosive esophagitis \| Gastroesophageal Reflux	248	Lansoprazole+X842 Dummy (X842 25 mg BID)	mptjnqapnr = ftozkgpjer jhipeztqpq (jfamlgdkvv, xsxqnuxped - yrecwckvlf) View more	-	01 Nov 2023
				Lansoprazole+X842 Dummy (X842 50 mg BID)	mptjnqapnr = qxcowaiiuu jhipeztqpq (jfamlgdkvv, inyuuxbndg - tvteusclod) View more
UEGW2023	Not Applicable	-	-	Linaprazan glurate 25 mg BID	opqsjrvwca(eliefhsabi) = zljdpbinsb jgkxbfeiau (dzlcwpriax, 59.7 - 84.7)	-	15 Oct 2023
				Linaprazan glurate 50 mg BID	opqsjrvwca(eliefhsabi) = qyxdcpowml jgkxbfeiau (dzlcwpriax, 73.8 - 91.1)

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