Protagonist Therapeutics (PTGX) Drug Pipeline

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Drug pipeline
Drug Name	Condition	Stage	Status	Study Name	Trial Start Date	Article
Pn-881 Oral Solution, Pn-881 Oral Tablet	Healthy Volunteer	Phase I	Not Yet Recruiting	Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.	Aug 22, 2025
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	―
Rusfertide	Polycythemia Vera	Phase III	Active Not Recruiting	A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera	Jan 14, 2022	―
Pn-232	Healthy Subjects	Phase I	Completed	Pharmacokinetics of PN-232 in Healthy Volunteers	Mar 24, 2021	―
Ptg-300	Polycythemia Vera	Phase II	Completed	PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit	Feb 18, 2021	―
Pn-235	Healthy Volunteers	Phase I	Completed	Pharmacokinetics of PN-235 in Healthy Volunteers	Oct 29, 2020	―
Ptg-300	Healthy Volunteers	Phase I	Completed	Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers	Aug 10, 2020	―
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	―
Ptg-300	Hereditary Hemochromatosis	Phase II	Completed	PTG-300 in Subjects With Hereditary Hemochromatosis	Dec 16, 2019	―
Ptg-300	Β-Thalassemia, Ineffective Erythropoiesis	Phase II	Completed	Safety Study for Beta Thalassemia Subjects on PTG-300	Aug 08, 2019	―

Drug pipeline
Drug Name	Stage	Condition	Status	Study Name	Trial Start Date	Article
Pn-881 Oral Solution, Pn-881 Oral Tablet	Phase I	Healthy Volunteer	Not Yet Recruiting	Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects.	Aug 22, 2025
Open-Label Rusfertide	Phase III	Polycythemia Vera	Active Not Recruiting	Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera	Sep 05, 2023	―
Rusfertide	Phase III	Polycythemia Vera	Active Not Recruiting	A Phase 3 Study of Rusfertide in Patients With Polycythemia Vera	Jan 14, 2022	―
Pn-232	Phase I	Healthy Subjects	Completed	Pharmacokinetics of PN-232 in Healthy Volunteers	Mar 24, 2021	―
Ptg-300	Phase II	Polycythemia Vera	Completed	PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit	Feb 18, 2021	―
Pn-235	Phase I	Healthy Volunteers	Completed	Pharmacokinetics of PN-235 in Healthy Volunteers	Oct 29, 2020	―
Ptg-300	Phase I	Healthy Volunteers	Completed	Pharmacokinetics and Pharmacodynamics of Different PTG-300 Regimens in Healthy Volunteers	Aug 10, 2020	―
Pn-943	Phase II	Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe	Completed	PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)	Aug 05, 2020	―
Ptg-300	Phase II	Hereditary Hemochromatosis	Completed	PTG-300 in Subjects With Hereditary Hemochromatosis	Dec 16, 2019	―
Ptg-300	Phase II	Β-Thalassemia, Ineffective Erythropoiesis	Completed	Safety Study for Beta Thalassemia Subjects on PTG-300	Aug 08, 2019	―

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

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 Inc (PTGX) have in its pipeline

Protagonist Therapeutics PTGX is currently developing the following drugs: Pn-881 Oral Solution, Pn-881 Oral Tablet, Open-Label Rusfertide, Rusfertide, Pn-232, Ptg-300, Pn-235, Pn-943, Ptg-100. These drug candidates are in various stages of clinical development as the company works toward FDA approval.

Protagonist Therapeutics stock drug pipeline

Protagonist Therapeutics (PTGX) Drug Pipeline

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