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Cinclus Pharma Holding AB (SE:CINPHA)
:CINPHA
Linaprazan Glurate 50 Mg Twice Daily (Bid), Linaprazan Glurate 50 Mg Once Daily (Qd), Lansoprazole 30 Mg Once Daily (Qd)
Gerd (Gastroesophageal Reflux Disease)
Phase III
Not Yet Recruiting
A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD)
Jun 17, 2025
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Linaprazan Glurate 25 Mg Qd, Linaprazan Glurate 50 Mg Qd, Linaprazan Glurate 75 Mg Qd, Linaprazan Glurate 25 Mg Bid, Linaprazan Glurate 50 Mg Bid, Linaprazan Glurate 75 Mg Bid
Gerd
Phase I
Completed
Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects
Jan 02, 2023
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Linaprazan Glurate, Drug Drug Interaction (Ddi) - Clarithromycin (Part I), Drug Drug Interaction (Ddi) - Midazolam (Part 2)
Pharmacokinetics, Tolerability, Safety Issues, Drug Interaction
Phase I
Completed
Effect of Clarithromycin on PK of Linaprazan, Linaprazan on PK of Clarithromycin and Linaprazan on PK of Midazolam
Nov 21, 2022
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Linaprazan Glurate
Pharmacokinetics, Safety, Bioavailability
Phase I
Completed
Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation
Nov 16, 2022
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Cinclus Pharma Holding AB (CINPHA) have in its pipeline
CINPHA is currently developing the following drugs: Linaprazan Glurate 50 Mg Twice Daily (Bid), Linaprazan Glurate 50 Mg Once Daily (Qd), Lansoprazole 30 Mg Once Daily (Qd), Linaprazan Glurate 25 Mg Qd, Linaprazan Glurate 50 Mg Qd, Linaprazan Glurate 75 Mg Qd, Linaprazan Glurate 25 Mg Bid, Linaprazan Glurate 50 Mg Bid, Linaprazan Glurate 75 Mg Bid, Linaprazan Glurate, Drug Drug Interaction (Ddi) - Clarithromycin (Part I), Drug Drug Interaction (Ddi) - Midazolam (Part 2). These drug candidates are in various stages of clinical development as the company works toward FDA approval.