Prader-willi Syndrome
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-03-09FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)
FDA approved a supplemental application for Norditropin (somatropin) by Novo Nordisk under BLA021148. The action pertains to changes approve…
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CLINICAL_TRIALS trial_result · 2019-06-27Clinical Trial Update: Study to Assess the Efficacy and Safety of Eutropin in Prader-Willi Syndrome [Phase 3]
A Phase 3 trial assessing efficacy and safety of Eutropin in Prader-Willi Syndrome has been completed.
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CLINICAL_TRIALS trial_result · 2019-06-25Clinical Trial Update: Intranasal Oxytocin for Infants With Prader-Willi Syndrome [Phase 1, Phase 2]
Phase 1/2 trial evaluating intranasal oxytocin in infants with Prader-Willi syndrome has completed with results posted in 2019.
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CLINICAL_TRIALS research · 2019-04-26Clinical Trial Update: Pilot Study of Startle-response Test to Assess Transcranial Direct Current Stimulation-induced Modulation of Hyperphagia in Prader-Willi Syndrome [NA]
A completed pilot clinical trial investigating a startle-response test to assess how transcranial direct current stimulation may modulate hy…
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CLINICAL_TRIALS trial_result · 2019-01-30Clinical Trial Update: Follow-up of Prader Willi Syndrome Infants Treated by Oxytocin and Comparison With Not-treated Infants. [NA]
Follow-up results from a completed clinical trial investigating oxytocin treatment in infants with Prader-Willi syndrome, comparing treated …
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CLINICAL_TRIALS trial_result · 2018-06-21Clinical Trial Update: Effects of Progressive Elastic Band Resistance Training [NA]
This update reports on a completed clinical trial studying the effects of progressive elastic band resistance training in individuals with P…
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CLINICAL_TRIALS research · 2018-06-12Clinical Trial Update: A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome [Phase 3]
A Phase 3 clinical trial is evaluating the efficacy and safety of recombinant human growth hormone injections in patients with Prader-Willi …
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CLINICAL_TRIALS trial_result · 2018-04-11Clinical Trial Update: Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 Weeks [Phase 3]
Phase 3 trial evaluating topiramate for Prader-Willi syndrome was terminated; no efficacy results are provided in this update.
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CLINICAL_TRIALS trial_result · 2018-04-05Clinical Trial Update: Oxytocin Trial in Prader-Willi Syndrome [Phase 1]
This update reports that a Phase 1 oxytocin trial in Prader-Willi syndrome has completed. The sponsor listed is the University of Florida.
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FDA approval · 2018-01-30FDA Approved: ZOMACTON — Supplemental Application (Ferring Pharmaceuticals Inc.)
FDA approved a supplemental application for ZOMACTON (somatropin) by Ferring Pharmaceuticals. The action updates the product's indications o…
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CLINICAL_TRIALS research · 2017-11-06Clinical Trial Update: Effects of Transcranial Direct Current Stimulation (tDCS) on Individuals With Prader-Willi Syndrome [NA]
A clinical trial update examines the effects of transcranial direct current stimulation (tDCS) in individuals with Prader-Willi syndrome, in…
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FDA label_change · 2017-05-24FDA Approved: SEROSTIM — Supplemental Application (EMD Serono, Inc.)
FDA approved a supplemental application for SEROSTIM (somatropin) from EMD Serono, Inc. to update the product labeling. The changes expand o…
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CLINICAL_TRIALS trial_result · 2017-05-12Clinical Trial Update: Comparative Study Between Prader-Willi Patients Who Take Oxytocin Versus Placebo [Phase 2]
A Phase 2 trial comparing oxytocin to placebo in Prader-Willi syndrome has completed.
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CLINICAL_TRIALS trial_result · 2017-02-24Clinical Trial Update: Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers [Phase 1]
A Phase 1 bioequivalence trial comparing Norditropin and Genotropin somatropin in healthy adult volunteers has completed, assessing pharmaco…
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CLINICAL_TRIALS trial_result · 2017-02-23Clinical Trial Update: Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies [Phase 1, Phase 2]
A completed Phase 1/2 trial evaluating the tolerability of intranasal oxytocin in newborns with Prader-Willi syndrome.
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CLINICAL_TRIALS trial_result · 2017-01-26Clinical Trial Update: Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome [Phase 3]
Phase 3 trial of beloranib (ZGN-440) in obese individuals with Prader-Willi syndrome was terminated.
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CLINICAL_TRIALS trial_result · 2016-12-14Clinical Trial Update: Prader-Willi Syndrome Macronutrient Study [NA]
This clinical trial update notes the completion of a macronutrient study for Prader-Willi syndrome and related obesity conditions conducted …
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CLINICAL_TRIALS trial_result · 2016-09-29Clinical Trial Update: Effects of Exenatide on Overweight Adolescents With Prader-Willi Syndrome [NA]
A clinical trial evaluating the effects of exenatide in overweight adolescents with Prader-Willi syndrome has completed and posted results.
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CLINICAL_TRIALS trial_result · 2016-09-13Clinical Trial Update: Nordic Study on the Effects of Growth Hormone (Norditropin SimpleXx) Treatment in Adults With Prader-Willi Syndrome [NA]
This update reports on a completed Nordic study evaluating the effects of growth hormone (Norditropin SimpleXx) in adults with Prader-Willi …
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CLINICAL_TRIALS research · 2016-09-09Clinical Trial Update: A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR) [Phase 2]
This clinical trial update reports a Phase 2 pharmacokinetic study of the diazoxide choline controlled-release tablet (DCCR) in Prader-Willi…
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CLINICAL_TRIALS trial_result · 2016-09-01Clinical Trial Update: Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome [Phase 1, Phase 2]
Phase 1/Phase 2 clinical study of Diazoxide Choline Controlled-Release Tablet (DCCR) for Prader-Willi syndrome has completed (status: COMPLE…
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CLINICAL_TRIALS research · 2016-08-24Clinical Trial Update: Aromatase Inhibitor in Bone Maturation, Children With Silver Russell or Prader-Willi Syndrome [NA]
A clinical trial update notes an investigation of an aromatase inhibitor to affect bone maturation in children with Silver-Russell syndrome …
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CLINICAL_TRIALS trial_result · 2016-07-18Clinical Trial Update: An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome [Phase 2]
A Phase 2 trial evaluating beloranib for efficacy, safety, and pharmacokinetics in individuals with Prader-Willi syndrome-associated obesity…
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FDA approval · 2016-06-23FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)
FDA approves a supplemental application for Norditropin (somatropin) from Novo Nordisk, indicating changes to labeling and/or indications.
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CLINICAL_TRIALS trial_result · 2016-04-05Clinical Trial Update: Post Exercise Irisin Levels in PWS Patients [NA]
A clinical trial update about post-exercise irisin levels in patients with Prader-Willi syndrome; no status or results are provided.