Tuberous Sclerosis Complex
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-06-21FDA Approved: ZTALMY — Supplemental Application (Immedica Pharma US Inc)
FDA approved a supplemental application for ZTALMY (ganaxolone) submitted by Immedica Pharma US Inc. The approval updates the product label …
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FDA approval · 2022-08-29FDA Approved: VIGABATRIN — Original Application (Hikma Pharmaceuticals USA Inc)
FDA approved Hikma's generic Vigabatrin under an Original Application (ANDA 213104). This notice confirms approval of a generic Vigabatrin p…
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CLINICAL_TRIALS trial_result · 2022-07-14Clinical Trial Update: An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) [Phase 3]
Open-label extension of cannabidiol (GWP42003-P) in seizures associated with tuberous sclerosis complex completed Phase 3.
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CLINICAL_TRIALS trial_result · 2022-04-25Clinical Trial Update: RAPAMYCIN FOR KIDNEY ANGIOMYOLIPOMAS [Phase 2]
Phase 2 trial update for rapamycin targeting kidney angiomyolipomas associated with tuberous sclerosis; trial completed with results posted.
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FDA approval · 2022-03-22FDA Approved: HYFTOR — Original Application (Nobelpharma America, LLC)
FDA approved HYFTOR (sirolimus) under an original application from Nobelpharma America, expanding treatment options with a topical sirolimus…
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FDA approval · 2021-09-30FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA has approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, Inc., indicating an update to its app…
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CLINICAL_TRIALS trial_result · 2021-09-09Clinical Trial Update: Safety and Efficacy of Everolimus (Afinitor®) in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex. [Phase 4]
Phase 4 trial assessing safety and efficacy of Everolimus (Afinitor) in Chinese adults with angiomyolipoma associated with tuberous sclerosi…
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CLINICAL_TRIALS trial_result · 2021-09-01Clinical Trial Update: A Pilot Study To Evaluate The Effects of Everolimus on Brain mTOR Activity and Cortical Hyperexcitability in TSC and FCD [Phase 2]
Phase 2 pilot study evaluating everolimus on brain mTOR activity and cortical hyperexcitability in epilepsy related to tuberous sclerosis co…
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CLINICAL_TRIALS withdrawal · 2021-05-03Clinical Trial Update: Topical Everolimus in Patients With Tuberous Sclerosis Complex [Phase 2, Phase 3]
A clinical trial for topical everolimus in facial angiofibromas associated with tuberous sclerosis complex was withdrawn.
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CLINICAL_TRIALS trial_result · 2021-03-29Clinical Trial Update: Rapalogues for Autism Phenotype in TSC: A Feasibility Study [Phase 2]
Phase 2 feasibility study evaluating rapalogue treatment for autism phenotype in tuberous sclerosis complex with self-injury; study complete…
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CLINICAL_TRIALS trial_result · 2020-09-23Clinical Trial Update: A Randomized Controlled Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) [Phase 3]
Phase 3 randomized trial assessing cannabidiol (GWP42003-P CBD) for seizures in tuberous sclerosis complex has completed with results posted…
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CLINICAL_TRIALS trial_result · 2020-08-25Clinical Trial Update: Safety of Simvastatin in LAM and TSC [Phase 1, Phase 2]
A Phase 1/2 trial reported on the safety of simvastatin in patients with Lymphangioleiomyomatosis and Tuberous Sclerosis Complex; study comp…
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CLINICAL_TRIALS trial_result · 2020-06-09Clinical Trial Update: Aspirin as an add-on Treatment of Refractory Epilepsy in Tuberous Sclerosis Complex [Phase 2]
A Phase 2 clinical trial investigates aspirin as an add-on treatment for refractory epilepsy in tuberous sclerosis complex.
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FDA approval · 2019-05-22FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals, updating the labeling to reflect the new …
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FDA approval · 2018-12-12FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Epidiolex (cannabidiol) submitted by Jazz Pharmaceuticals, Inc. The action updates the produ…
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CLINICAL_TRIALS trial_result · 2018-11-07Clinical Trial Update: A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures [Phase 3]
Phase 3 trial evaluating efficacy and safety of two trough ranges of everolimus as adjunctive therapy in tuberous sclerosis complex–associat…
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CLINICAL_TRIALS trial_result · 2018-05-02Clinical Trial Update: Early Behavioral Intervention to Improve Social Communication Function in Infants With Tuberous Sclerosis Complex [NA]
This is an update on a completed clinical trial evaluating early behavioral intervention to improve social communication in infants with tub…
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CLINICAL_TRIALS trial_result · 2018-01-25Clinical Trial Update: Trial of RAD001 and Neurocognition in Tuberous Sclerosis Complex (TSC) [Phase 2]
Phase 2 trial update for RAD001 in tuberous sclerosis complex evaluating neurocognition; study completed with results posted in 2018.
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CLINICAL_TRIALS trial_result · 2018-01-23Clinical Trial Update: Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers [Phase 2]
Phase 2 trial evaluating beta-blockers for treatment of renal angiomyolipomas in tuberous sclerosis has completed.
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CLINICAL_TRIALS trial_result · 2017-05-04Clinical Trial Update: Topical Rapamycin and Calcitriol for Angiofibroma of Tuberous Sclerosis [Phase 3]
Phase 3 trial evaluating topical rapamycin combined with calcitriol for facial angiofibromas in tuberous sclerosis complex has completed.
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CLINICAL_TRIALS research · 2017-05-04Clinical Trial Update: Tuberous Sclerosis Complex Natural History Study: Renal Manifestations
A completed clinical trial update for the Tuberous Sclerosis Complex Natural History Study focusing on renal manifestations.
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CLINICAL_TRIALS trial_result · 2017-02-02Clinical Trial Update: Phase III Trial of Topical Formulation of Sirolimus to Skin Lesions in Patients With Tuberous Sclerosis Complex (TSC) [Phase 3]
Phase 3 trial evaluating topical sirolimus for skin lesions in tuberous sclerosis complex has completed.
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CLINICAL_TRIALS trial_result · 2016-09-23Clinical Trial Update: Everolimus (RAD001) Therapy for Epilepsy in Patients With Tuberous Sclerosis Complex (TSC) [Phase 1, Phase 2]
A completed Phase 1/2 clinical trial evaluated everolimus for epilepsy in patients with tuberous sclerosis complex; results were posted in 2…
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CLINICAL_TRIALS trial_result · 2016-08-19Clinical Trial Update: Tuberous Sclerosis Complex: Facial Angiofibroma Skin Cream [Phase 1]
Phase 1 trial of a facial angiofibroma skin cream for tuberous sclerosis complex has completed.
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CLINICAL_TRIALS trial_result · 2015-12-02Clinical Trial Update: Doxycycline In Lymphangioleiomyomatosis (LAM) [Phase 4]
Phase 4 trial of doxycycline in lymphangioleiomyomatosis (LAM) has been completed, including cases associated with tuberous sclerosis comple…