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Clinical trials
catalyst calendar across sponsors →Studies where TVTX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
11 interventional · 3 observational · 6 with posted results
Held by 16 tracked-famous managers (RENAISSANCE TECHNOLOGIES LLC, TWO SIGMA INVESTMENTS, LP, Qube Research & Technologies Ltd, D. E. Shaw & Co., Inc., MARSHALL WACE, LLP, +11 more) · FINRA short interest 9.4 days to cover (settled 2026-07-31) · insider 90d: 0 buys / 2 sells · government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| A 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)NCT06431893Treatment-emergent AEsOpen-label · Treatment | Phase 3 | Enrolling by invitation | Drug: Pegtibatinase | Homocystinuria | 100 | Aug 2030 | ≤ 1,472 d | 2026-05-28 |
| 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 TreatmentNCT06247085Change from baseline in plasma tHcy levels - Weeks 6 to 12Randomized · Quadruple-masked · Treatment | Phase 3 | Recruiting | Drug: Pegtibatinase · Other: Placebo | Homocystinuria | 70 | Aug 2027 | ≤ 376 d | 2026-08-07 |
| Pegtibatinase as a Treatment for Patients With Classical Homocystinuria (HCU) (Also Known as the COMPOSE Study)NCT03406611Incidence of AEsRandomized · Quadruple-masked · Treatment | Phase 1/2 | Recruiting | Drug: Pegtibatinase, Placebo | Homocystinuria | 39 | Jul 2027 | ≤ 345 d | 2026-08-10 |
| Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental GlomerulosclerosisNCT07219121Urinary protein/creatinine ratio (UPCR)Open-label · Treatment | Phase 4 | Active, not recruiting | Drug: Sparsentan | Proteinuria, Immunoglobulin A (IgA) Nephropathy, Focal Segmental Glomerulosclerosis, Kidney Transplant | 20 | Mar 2027 | ≤ 223 d | 2026-06-23 |
| Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular DiseasesNCT05003986Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), AEs leading to treatment discontinuation, and adverse events of interest (AEOIs)Non-randomized · Open-label · Treatment | Phase 2 | Recruiting | Drug: Sparsentan, Sparsentan, Sparsentan | Focal Segmental Glomerulosclerosis, Minimal Change Disease, Immunoglobulin A Nephropathy, IgA Vasculitis, Alport Syndrome | 67 | 2027-03-12 | in 204 d | 2026-05-12 |
| Natural History Study of Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (ACAPPELLA)NCT02998710observationalChanges in Met cycle metabolites levels - tHcy | — | Recruiting | — | Homocystinuria Due to CBS Deficiency | 150 | Apr 2026 | — | 2024-11-22 |
| A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA NephropathyNCT03762850results2024-07-03Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Active, not recruiting | Drug: sparsentan, irbesartan, Dapagliflozin | Immunoglobulin A Nephropathy | 406 | 2023-08-07actual | — | 2026-04-20 |
| A Study to Investigate Safety and Effect of Sparsentan in Combination With SGLT2 Inhibition in Participants With IgANNCT05856760results2025-11-20Change in Urine Albumin-creatinine Ratio (UA/C) at Week 24Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Sparsentan | Immunoglobulin A Nephropathy | 48 | 2024-10-14actual | — | 2025-11-20 |
| Humanistic Burden of (FSGS) Focal Segmental Glomerulosclerosis and IgAN (Immunoglobulin A Nephropathy)NCT05200871observationalDemographics | — | Completed | — | Focal Segmental Glomerulosclerosis, Immunoglobulin A Nephropathy | 487 | 2023-10-31actual | — | 2024-02-21 |
| Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)NCT03493685results2024-04-30Slope of Estimated Glomerular Filtration Rate (eGFR)Randomized · Double-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: sparsentan, Irbesartan | Focal Segmental Glomerulosclerosis | 371 | 2023-03-20actual | — | 2026-04-17 |
| Cerebrotendinous Xanthomatosis (CTX) Prevalence StudyNCT02638220results2024-09-19observationalNumber of Participants Who Had Positive Genetic Test ResultsStudy Protocol ↗ · Statistical Analysis Plan ↗ | — | Completed | — | Cerebrotendinous Xanthomatosis (CTX) | 442 | 2021-02-19actual | — | 2024-09-19 |
| Study to Evaluate the Pharmacokinetics of Oral Sparsentan SuspensionNCT05562362Assessment of single-dose pharmacokinetics of sparsentan oral suspension dosed in fed and fasted states - CmaxRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: RE-021, sparsentan | Healthy Subjects | 47 | 2020-11-12actual | — | 2022-09-30 |
| Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN ParticipantsNCT03041116results2020-12-29Change From Baseline In The Pantothenate Kinase-Associated Neurodegeneration-Activities of Daily Living (PKAN-ADL) Total Score To The End Of The 24-week Double-blind PeriodRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 3 | Terminatedsponsor's stated reason: The study was terminated since fosmetpantotenate did not show statistically significant effects or clinical benefits during the double-blind period. | Drug: Fosmetpantotenate, Placebo | Pantothenate Kinase-Associated Neurodegeneration | 84 | 2019-12-30actual | — | 2021-01-26 |
| Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental GlomerulosclerosisNCT01613118results2021-07-27Percent Change in Urine Protein/Creatinine (Up/C)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: RE-021 (Sparsentan), Irbesartan | Focal Segmental Glomerulosclerosis | 109 | Jun 2016actual | — | 2025-05-15 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19