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Travere Therapeutics (TVTX)
NASDAQ:TVTX
Sparsentan
Focal Segmental Glomerulosclerosis, Kidney Transplant, Proteinuria, Immunoglobulin A (Iga) Nephropathy
Phase IV
Recruiting
Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis
Oct 09, 2025
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Pegtibatinase
Homocystinuria
Phase III
Enrolling By Invitation
A Phase 3 Long-term Extension Study to Assess the Long-term Safety and Efficacy of Pegtibatinase Treatment in Participants ≥5 to ≤65 Years of Age With Classical Homocystinuria (HCU) (ENSEMBLE)
May 08, 2024
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Pegtibatinase
Homocystinuria
Phase III
Active Not Recruiting
A Study to Investigate Efficacy and Safety of Pegtibatinase Compared With Placebo in Participants ≥12 to ≤65 Years of Age With Classical Homocystinuria (HCU) Due to Cystathionine Beta Synthase Deficiency Receiving Standard of Care Treatment
Jan 30, 2024
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Sparsentan
Immunoglobulin A Nephropathy
Phase II
Completed
A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgAN
May 03, 2023
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Sparsentan
Focal Segmental Glomerulosclerosis, Immunoglobulin A Nephropathy, Alport Syndrome, Minimal Change Disease, Iga Vasculitis
Phase II
Recruiting
Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases
Jul 29, 2021
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Dapagliflozin, Irbesartan, Sparsentan
Immunoglobulin A Nephropathy
Phase III
Active Not Recruiting
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
Nov 27, 2018
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Irbesartan, Sparsentan
Focal Segmental Glomerulosclerosis
Phase III
Active Not Recruiting
Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
Apr 03, 2018
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Pegtibatinase
Homocystinuria
Phase I/II
Active Not Recruiting
Pegtibatinase As an Enzyme Therapy for Patients with Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (COMPOSE)
Dec 05, 2017
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Irbesartan, Re-021 (Sparsentan)
Focal Segmental Glomerulosclerosis
Phase II
Completed
Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis
Jun 04, 2012
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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 Travere Therapeutics (TVTX) have in its pipeline
TVTX is currently developing the following drugs: Sparsentan, Pegtibatinase, Pegtibatinase. These drug candidates are in various stages of clinical development as the company works toward FDA approval.