Education
About Us
Working with TipRanks
Follow Us
Rion Co., Ltd. (JP:6823)
:6823
Pep-Tisseel, Tisseel Fibrin Sealant Kit
Chronic Radiation Ulcer
Phase I/II
Not Yet Recruiting
Study to Evaluate the Safety, Tolerability, and Efficacy of PEP-TISSEEL in Subjects With Chronic Radiation Ulcer
Jan 16, 2025
―
Pep (Purified Exosome Product) / Tisseel
Diabetic Foot Ulcer
Phase II
Active Not Recruiting
Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU)
Mar 13, 2024
―
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 Rion Co., Ltd. (6823) have in its pipeline
6823 is currently developing the following drugs: Pep-Tisseel, Tisseel Fibrin Sealant Kit, Pep (Purified Exosome Product) / Tisseel. These drug candidates are in various stages of clinical development as the company works toward FDA approval.