Drugs / Linaprazan glurate
Linaprazan glurate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | — | 2023-08-19 | “the potassium-competitive acid blocker X842 (NDA application accepted)” sanyoubio.com ↗ |
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03105375 | Feb → Oct 2017 | — | Cinclus Pharma Holding AB | Completed | No outcome recorded |
| Phase 15 trials | ||||||
| Phase 1 | NCT07308041 | Nov → Dec 2025 | gastroesophageal reflux disease | Cinclus Pharma Holding AB | Completed | No outcome recorded |
| Phase 1 | NCT07294846 | Sep → Dec 2025 | — | Jiangsu Sinorda Biomedicine Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05469854 | Jul 2022 → Nov 2026 expected | gastroesophageal reflux disease | Cinclus Pharma Holding AB | Recruiting | No outcome recorded |
| Phase 1 | NCT07107672 | Jun → Jul 2022 | gastroesophageal reflux disease | Jiangsu Sinorda Biomedicine Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04293965 | Oct 2018 → Sep 2019 | — | Jiangsu Sinorda Biomedicine Co., Ltd | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT05055128 | Aug 2021 → Sep 2022 | esophagitis | Cinclus Pharma Holding AB | Completed | No outcome recorded |
| Phase 2 | NCT04531475 | Jan → Oct 2020 | peptic esophagitis | Jiangsu Sinorda Biomedicine Co., Ltd | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT07079540 | Jun 2021 → Jul 2022 | peptic esophagitis | Jiangsu Sinorda Biomedicine Co., Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-10-05 | Cinclus Pharma Holding AB | Results Cinclus Pharma: New scientific article highlights rapid and sustained acid control with linaprazan glurate cincluspharma.com ↗
The data in these studies demonstrates rapid and sustained acid control with close to 100% pH control at the highest dose levels. |
| 2026-02-13 | Cinclus Pharma Holding AB | Regulatory Cinclus Pharma receives positive assessment of its nonclinical development plan from the FDA cincluspharma.com ↗
Cinclus Pharma Holding AB (publ), a late‑stage clinical pharmaceutical company developing next‑generation treatments for gastric acid‑related diseases, today announced that the US Food and Drug Administration (FDA) has provided a positive assessment of the company’s nonclinical development plan for its drug candidate linaprazan glurate following a scientific advice meeting. |
| 2025-12-08 | Cinclus Pharma Holding AB | Regulatory Cinclus Pharma’s linaprazan glurate earns China’s National Reimbursement Listing and is set to launch in China in 2026 cincluspharma.com ↗
today announced that its drug, linaprazan glurate, has been included in China’s 2025 National Reimbursement Drug List (NRDL) for the treatment of gastroesophageal reflux disease (GERD). |
| 2025-09-23 | Cinclus Pharma Holding AB | Results Cinclus Pharma to present linaprazan glurate data at the European Gastroenterology Week (UEGW) cincluspharma.com ↗
The data demonstrate that the optimized linaprazan glurate HCl tablet formulation achieves approximately a two-fold increase in bioavailability compared with the formulation used in earlier studies, with only a minor impact observed when administered under fasting versus fed conditions. |
| 2025-06-16 | Cinclus Pharma Holding AB | Regulatory Cinclus Pharma secures EMA and FDA pediatric study waivers for linaprazan glurate in H. pylori infection cincluspharma.com ↗
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. |
| 2025-05-06 | Cinclus Pharma Holding AB | Results Cinclus Pharmas presents positive data on linaprazan glurate at international scientific conference cincluspharma.com ↗
The first presentation showed data on linaprazan glurate's capacity to inhibit hydrochloric acid production in the stomach and keep the degree of acid under very good control. |
| 2025-04-07 | Cinclus Pharma Holding AB | Results New scientific article highlights good healing results for Cinclus Pharma's drug candidate linaprazan glurate for the treatment of eGERD cincluspharma.com ↗
The published article presents data from a phase II clinical trial in which the treatment with linaprazan glurate (the next generation of PCAB) showed a high healing rate among patients suffering from eGERD. |
| 2024-12-04 | SPH-BIOCAD (HK) Limited | Regulatory 上海医药戊二酸利那拉生酯胶囊（X842项目）上市许可申请获得批准 sphchina.com ↗
近日，上药信谊与贵州生诺合作开发的X842项目获得国家药品监督管理局下发的《药品注册证书》（证书编号：2024S03003），该药品上市许可申请获国家药监局批准。 |
| 2024-12-04 | Cinclus Pharma Holding AB | Regulatory Linaprazan glurate receives marketing approval in China cincluspharma.com ↗
Cinclus Pharma, a clinical-stage pharmaceutical company developing molecules for the treatment of gastric acid-related diseases, today announced that its leading drug candidate, linaprazan glurate, has received its first marketing approval for the treatment of gastroesophageal reflux disease (GERD). |
| 2024-11-22 | Cinclus Pharma Holding AB | Regulatory Cinclus Pharma agrees on pediatric study plan with FDA cincluspharma.com ↗
Cinclus Pharma, a clinical-stage pharmaceutical company developing molecules for the treatment of acid-related diseases, today announces that it has reached an agreement with the US Food and Drug Administration (FDA) on the company’s initial Pediatric Study Plan (iPSP). |
| 2024-10-29 | Cinclus Pharma Holding AB | Regulatory Cinclus Pharma agrees on Pediatric Investigation Plan (PIP) with EMA cincluspharma.com ↗
Cinclus Pharma, a clinical-stage pharmaceutical company developing molecules for the treatment of acid-related diseases, today announces that it has reached an agreement with the European Medicines Agency’s (EMA) Paediatric Commmittee (PDCO) on the company’s Pediatric Investigation Plan (PIP). |
| 2024-09-24 | Cinclus Pharma Holding AB | Results Cinclus Pharma's data presented at UEG cincluspharma.com ↗
The study results show that linaprazan glurate has a very rapid and effective acid inhibition already 90 minutes after first dosing. |
| 2023-10-16 | Cinclus Pharma Holding AB | Results Cinclus Pharma's phase II eGERD study in two presentations at UEG cincluspharma.com ↗
For Cinclus Pharma's primary patient population, patients with moderate to severe eGERD, the highest four-week healing rate in a linaprazan glurate dosing group was 89%, compared to 38% in the lansoprazole group. |
| 2023-05-09 | Cinclus Pharma Holding AB | Results Cinclus Pharma’s phase II eGERD study in oral presentation at DDW cincluspharma.com ↗
For Cinclus Pharma’s primary patient population, patients with moderate to severe eGERD, the highest four-week healing rate in a linaprazan glurate dosing group was 89%, compared to 38% in the lansoprazole group. |
| 2022-11-04 | Cinclus Pharma Holding AB | Results Cinclus Pharma announces positive topline results from the LEED phase II eGERD study cincluspharma.com ↗
For patients with moderate to severe eGERD, LA grade C/D, the highest four-week healing rate in a linaprazan glurate dosing group was 89%, compared to 38% in the lansoprazole group. |
| 2022-09-05 | Cinclus Pharma Holding AB | Regulatory Cinclus Pharma receives QIDP designation cincluspharma.com ↗
We are very pleased to receive QIDP designation from the FDA for linaprazan glurate and are looking forward to working with the FDA to rapidly make this P-CAB, linaprazan glurate, available to patients. |
| 2021-09-06 | Cinclus Pharma Holding AB | Regulatory Cinclus Pharma receives approval of the International Nonproprietary Name (INN) linaprazan glurate for its lead drug candidate for the treatment of GERD cincluspharma.com ↗
Stockholm, Sweden: Cinclus Pharma Holding AB (“Cinclus Pharma”), a biopharmaceutical company focused on the development of a novel treatment for severe gastroesophageal reflux disease (“GERD”), today announced that the World Health Organization (WHO) has designated linaprazan glurate as the International Nonproprietary Name (INN) for its lead drug candidate, formerly known as X842. |
| 2018-04-16 | Cinclus Pharma Holding AB | Results First clinical study successfully completed with X842, an innovative promising treatment for severe erosive GERD cincluspharma.com ↗
The study showed that X842 was safe and well tolerated. |
All press releases naming this drug 25 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Linaprazan glurate | “Linaprazan glurate, a potassium-competitive acid blocker, is in development for the treatment of erosive oesophagitis and other acid-related diseases.” PMID 40183130 ↗ Apr 20253“The participants will then continue to take linaprazan glurate (Day 2 to Day 8).” NCT07308041 ↗ |
| Known as | Glurate de linaprazan | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095187 ↗ |
| Known as | Glurato de linaprazan | ChEMBL registry synonym — accepted as the source's own label CHEMBL5095187 ↗ |
| Known as | X842 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04293965 ↗ |
| Modality | Small molecule | — CHEMBL5095187 ↗ |
| Route | Oral | “X842 50 mg, capsule, orally, once daily” NCT04531475 ↗ |