Sialorrhea
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CLINICAL_TRIALS research · 2025-09-05Clinical Trial Update: Chewing Gum as a Therapeutic Intervention for the Management of Hypersalivation [NA]
A clinical trial is evaluating chewing gum as a therapeutic intervention for hypersalivation; the study is not yet recruiting.
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CLINICAL_TRIALS trial_result · 2025-07-24Clinical Trial Update: Botulinum Toxin Injections Into the Salivary Glands of Cerebrospinal Children With Chronic Sialorrhea
A clinical trial studying botulinum toxin injections into the salivary glands for chronic sialorrhea in children with brain injuries has com…
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EMA approval · 2025-04-11EMA Authorised: Sialanar (glycopyrronium bromide) — Proveca Pharma Limited
The EMA authorised Sialanar (glycopyrronium bromide) by Proveca Pharma Limited for the treatment of sialorrhea.
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CLINICAL_TRIALS trial_result · 2024-12-18Clinical Trial Update: Pharmacokinetics of Atropine Oral Gel [EARLY_Phase 1]
This early Phase 1 trial update reports pharmacokinetic data for an atropine oral gel studied to treat sialorrhea in cerebral palsy. The Pha…
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CLINICAL_TRIALS withdrawal · 2024-09-19Clinical Trial Update: Efficacy and Safety Study of MYOBLOC in the Treatment of Sialorrhea in Pediatric Subjects [Phase 3]
A Phase 3 study evaluating MYOBLOC for treating sialorrhea in pediatric subjects has been withdrawn.
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FDA approval · 2023-02-27FDA Approved: GLYCOPYRROLATE — Original Application (Lifestar Pharma LLC)
FDA approves Lifestar Pharma LLC's original ANDA for glycopyrrolate, a generic version of the drug.
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CLINICAL_TRIALS trial_result · 2022-07-08Clinical Trial Update: Double-blind, Placebo-controlled, Randomized Clinical Trial Comparing the Efficacy and Safety of Sialanar Plus orAl rehabiLitation Against Placebo Plus Oral Rehabilitation for chIldren and Adolescents With seVere Sialorrhoea and Neurodisabilties, [Phase 4]
Phase 4 randomized trial comparing Sialanar Plus/Al rehabilitation versus placebo/rehabilitation for severe sialorrhea in children/adolescen…
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FDA approval · 2021-10-13FDA Approved: GLYCOPYRROLATE — Original Application (Nivagen Pharmaceuticals, Inc.)
FDA approves an original ANDA for a generic glycopyrrolate product from Nivagen Pharmaceuticals.
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CLINICAL_TRIALS trial_result · 2019-11-04Clinical Trial Update: Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults [Phase 3]
Open-label, single-arm Phase 3 study evaluating MYOBLOC for troublesome sialorrhea in adults; results have been posted.
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CLINICAL_TRIALS trial_result · 2019-08-15Clinical Trial Update: Efficacy and Safety Study of MYOBLOC® in the Treatment of Sialorrhea in Adult Subjects [Phase 3]
A Phase 3 efficacy and safety study of MYOBLOC for treating adult sialorrhea has completed, with results posted in 2019.
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CLINICAL_TRIALS trial_result · 2018-11-21Clinical Trial Update: Ipratropium Bromide Spray as Treatment for Sialorrhea in Children [Phase 2]
Phase 2 clinical trial evaluating ipratropium bromide spray as a treatment for sialorrhea in children.
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CLINICAL_TRIALS trial_result · 2018-02-28Clinical Trial Update: Clozapine-induced Hypersalivation - Feasibility Trial [Phase 1, Phase 2]
A completed Phase 1/2 feasibility trial investigating approaches to clozapine-induced hypersalivation (sialorrhea).
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FDA approval · 2018-02-23FDA Approved: CUVPOSA — Supplemental Application (Merz Pharmaceuticals, LLC)
FDA approved a supplemental application for CUVPOSA (glycopyrrolate) by Merz Pharmaceuticals, LLC. The action updates the product's labeling…
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CLINICAL_TRIALS trial_result · 2018-02-15Clinical Trial Update: Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions [Phase 3]
Phase 3 trial comparing two doses of NT-201 to placebo for chronic troublesome sialorrhea in neurological conditions has completed. Results …
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CLINICAL_TRIALS trial_result · 2016-06-13Clinical Trial Update: Management of Drooling in Children With Cerebral Palsy in France
The document reports the completion of a clinical trial evaluating management approaches for drooling in children with cerebral palsy in Fra…
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CLINICAL_TRIALS trial_result · 2015-12-10Clinical Trial Update: Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients [Phase 2]
Phase 2 study evaluating tropicamide thin films to reduce hypersalivation in Parkinson's disease has completed, assessing safety and efficac…
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CLINICAL_TRIALS trial_result · 2014-04-03Clinical Trial Update: Efficacy of Intravenous Glyco-P® in Patients Undergoing Procedure That Require Anesthesia Service
Completed clinical trial evaluating intravenous Glyco-P (glycopyrrolate) for reducing hypersalivation in patients undergoing procedures requ…
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FDA approval · 2013-05-21FDA Approved: CUVPOSA — Supplemental Application (Merz Pharmaceuticals, LLC)
The FDA approved a supplemental application for CUVPOSA (glycopyrrolate) by Merz Pharmaceuticals, LLC. This action corresponds to NDA 022571…
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CLINICAL_TRIALS research · 2012-10-30Clinical Trial Update: Application of Botulinum Toxin Type A in Salivary Glands in the Treatment of Drooling in Patients With Cerebral Palsy [Phase 2, Phase 3]
Clinical trial update on injecting botulinum toxin type A into salivary glands to treat drooling in children with cerebral palsy. It encompa…
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CLINICAL_TRIALS trial_result · 2012-07-09Clinical Trial Update: Safety and Efficacy Study of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age With Cerebral Palsy or Other Neurologic Conditions [Phase 3]
Phase 3 trial evaluating oral glycopyrrolate liquid for treating pathologic drooling in children with cerebral palsy or other neurologic con…
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CLINICAL_TRIALS trial_result · 2012-03-14Clinical Trial Update: Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS) [Phase 2, Phase 3]
This clinical trial evaluated Myobloc (rimabotulinumtoxinB) for reducing drooling in patients with Amyotrophic Lateral Sclerosis, and the st…
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FDA approval · 2010-07-28FDA Approved: CUVPOSA — Original Application (Merz Pharmaceuticals, LLC)
FDA approved the original application for CUVPOSA (glycopyrrolate) from Merz Pharmaceuticals, LLC, under NDA 022571. It is approved for the …