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Protagonist Therapeutics (PTGX)
NASDAQ:PTGX
Open-Label Rusfertide
Polycythemia Vera
Phase III
Active Not Recruiting
Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera
Sep 05, 2023
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Rusfertide
Polycythemia Vera
Phase III
Active Not Recruiting
A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera
Jan 14, 2022
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Pn-232
Healthy Subjects
Phase I
Completed
Pharmacokinetics of PN-232 in Healthy Volunteers
Mar 24, 2021
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Ptg-300
Polycythemia Vera
Phase II
Completed
PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit
Feb 18, 2021
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Pn-235
Healthy Volunteers
Phase I
Completed
Pharmacokinetics of PN-235 in Healthy Volunteers
Oct 29, 2020
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Ptg-300
Healthy Volunteers
Phase I
Completed
Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers
Aug 10, 2020
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Pn-943
Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
Phase II
Completed
PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
Aug 05, 2020
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Ptg-300
Hereditary Hemochromatosis
Phase II
Completed
PTG-300 in Subjects With Hereditary Hemochromatosis
Dec 16, 2019
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Ptg-300
Β-Thalassemia, Ineffective Erythropoiesis
Phase II
Completed
Safety Study for Beta Thalassemia Subjects on PTG-300
Aug 08, 2019
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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 Protagonist Therapeutics (PTGX) have in its pipeline
PTGX is currently developing the following drugs: Pn-881 Oral Solution, Pn-881 Oral Tablet, Open-Label Rusfertide, Rusfertide. These drug candidates are in various stages of clinical development as the company works toward FDA approval.