Cystinuria
📧 Sign up to get email alerts when something new happens for Cystinuria.
Sign up freeTop drugs studied for this disease
-
CLINICAL_TRIALS trial_result · 2026-04-15Clinical Trial Update: Lipoic Acid Supplement for Cystine Stone [Phase 2]
Phase 2 trial of alpha-lipoic acid for limiting cystine stone recurrence in cystinuria was completed, with results posted.
-
CLINICAL_TRIALS withdrawal · 2026-01-08Clinical Trial Update: Study Evaluating Patients With Cystinuria and Efficacy and Safety Exploratory Study in the Youngest Children [Phase 2, Phase 3]
A cystinuria trial (Phase 2/Phase 3) sponsored by Advicenne Pharma has been withdrawn.
-
CLINICAL_TRIALS trial_result · 2025-10-08Clinical Trial Update: The Effect of Sodium-glucose Cotransporter (SGLT) 2 Inhibitors on Cystine Stone Formation: A Preliminary Study [Phase 2]
Phase 2 trial evaluating the effect of SGLT2 inhibitors on cystine stone formation in cystinuria has completed, and results were posted on 2…
-
FDA approval · 2025-08-29FDA Approved: TIOPRONIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application from Amneal Pharmaceuticals NY LLC for Tiopronin, enabling a generic Tiopronin product to be markete…
-
CLINICAL_TRIALS withdrawal · 2025-08-29Clinical Trial Update: Long Term Clinical Efficacy of Sodium-glucose Cotransporter-2 (SGLT-2) Inhibitor in Cystinurics [Phase 2]
A Phase 2 trial evaluating long-term clinical efficacy of an SGLT-2 inhibitor in individuals with cystinuria has been withdrawn.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS research · 2025-08-06Clinical Trial Update: Prospective Research Rare Kidney Stones (ProRKS)
A Mayo Clinic-led clinical trial (ProRKS) is currently recruiting for rare kidney stone conditions including hyperoxaluria, cystinuria, Dent…
-
CLINICAL_TRIALS research · 2025-07-22Clinical Trial Update: Rare Kidney Stone Consortium Biobank
This update notes that the Rare Kidney Stone Consortium Biobank, sponsored by Mayo Clinic, is currently recruiting to collect samples for ra…
-
CLINICAL_TRIALS research · 2025-07-04Clinical Trial Update: Rare Kidney Stone Consortium Patient Registry
A Mayo Clinic-sponsored Rare Kidney Stone Consortium patient registry is actively recruiting to collect data on patients with rare kidney st…
-
CLINICAL_TRIALS research · 2025-01-23Clinical Trial Update: Randall's Plaque Study: Pathogenesis and Relationship to Nephrolithiasis [NA]
An update on the Randall's plaque study examining how Randall's plaques form and their relationship to nephrolithiasis (kidney stones).
-
FDA approval · 2024-07-26FDA Approved: VENXXIVA — Supplemental Application (Cycle Pharmaceuticals Ltd.)
The FDA approved a supplemental application for VENXXIVA (tiopronin) submitted by Cycle Pharmaceuticals Ltd. under ANDA216990. The action au…
-
FDA approval · 2024-07-22FDA Approved: TIOPRONIN — Original Application (Teva Pharmaceuticals, Inc.)
FDA approves Teva's original application for Tiopronin as a generic drug for the treatment of cystinuria to prevent kidney stone formation.
-
CLINICAL_TRIALS withdrawal · 2024-03-12Clinical Trial Update: Study Evaluating Patients With Cystinuria [Phase 2, Phase 3]
A cystinuria clinical trial (Phase 2/3) sponsored by Advicenne Pharma was withdrawn.
-
FDA approval · 2024-01-30FDA Approved: VENXXIVA — Original Application (Cycle Pharmaceuticals Ltd.)
FDA approved VENXXIVA (tiopronin) from Cycle Pharmaceuticals Ltd. under an Original Application (ANDA216990).
-
FDA approval · 2023-08-15FDA Approved: TIOPRONIN — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approved the original ANDA (216278) for Tiopronin from Amneal Pharmaceuticals NY LLC, providing a generic option for treating cystinuria…
-
FDA approval · 2023-02-24FDA Approved: TIOPRONIN — Original Application (Endo USA, Inc.)
FDA approved an original generic application for Tiopronin, manufactured by Endo USA, Inc., for use in patients with cystinuria to prevent k…
-
CLINICAL_TRIALS trial_result · 2021-12-17Clinical Trial Update: Effect of Increasing Doses of Tiopronin on Cystine Capacity in Patients With Cystinuria [Phase 2]
Phase 2 trial evaluating increasing doses of tiopronin on cystine capacity in cystinuria; study completed with results posted.
-
CLINICAL_TRIALS trial_result · 2021-08-23Clinical Trial Update: Effect of Increasing Doses of Cystine Binding Thiol Drugs on Cystine Capacity in Patients With Cystinuria [Phase 4]
Phase 4 trial assessing how increasing doses of cystine binding thiol drugs affect cystine capacity in cystinuria patients.
-
FDA approval · 2021-08-23FDA Approved: PENICILLAMINE — Original Application (Breckenridge Pharmaceutical, Inc.)
The FDA approved Breckenridge Pharmaceutical's penicillamine under its original application (ANDA 215409), enabling a generic version of pen…
-
FDA approval · 2021-03-08FDA Approved: THIOLA EC — Supplemental Application (Mission Pharmacal Company)
FDA approved a supplemental application for THIOLA EC (tiopronin) from Mission Pharmacal Company, adding the extended-release formulation to…
-
FDA approval · 2020-08-04FDA Approved: PENICILLAMINE — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved Dr. Reddy's Laboratories' original application for penicillamine, a chelating agent used to treat Wilson's disease and cystinur…
-
CLINICAL_TRIALS research · 2020-06-04Clinical Trial Update: TCUPS- Tolvaptan Use in Cystinuria and Urolithiasis: A Pilot Study [NA]
A completed pilot clinical trial evaluating Tolvaptan use in cystinuria and urolithiasis; results posted in 2020.
-
FDA approval · 2019-12-23FDA Approved: PENICILLAMINE — Original Application (Endo USA, Inc.)
FDA approved Endo USA, Inc.'s original application for penicillamine as a generic drug product.
-
FDA approval · 2019-06-28FDA Approved: THIOLA EC — Original Application (Mission Pharmacal Company)
FDA approved THIOLA EC (tiopronin) as an enteric-coated formulation under Mission Pharmacal Company's original NDA for the prevention of rec…
-
FDA approval · 2019-06-28FDA Approved: THIOLA — Supplemental Application (Mission Pharmacal Company)
FDA approved a supplemental application for Thiola (tiopronin) from Mission Pharmacal Company, expanding its approved indication to prevent …
-
CLINICAL_TRIALS trial_result · 2017-05-18Clinical Trial Update: Bucillamine Phase 2 Trial in Patients With Cystinuria [Phase 2]
This entry reports a Phase 2 clinical trial evaluating bucillamine for cystinuria. The sponsor is Revive Therapeutics, Ltd.