Idiopathic Short Stature
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Sign up freeTop drugs studied for this disease
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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 · 2017-02-24Clinical 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 research · 2017-01-18Clinical Trial Update: Effect of Growth Hormone in Children With Growth Hormone Deficiency [Phase 3]
A Phase 3 clinical trial update assessing the effect of growth hormone in children with growth hormone deficiency; the trial status is compl…
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CLINICAL_TRIALS trial_result · 2016-10-18Clinical Trial Update: A Phase 3 Study to Evaluate the Safety and Efficacy of Saizen® in Children With Idiopathic Short Stature (ISS) [Phase 3]
Results from a Phase 3 study evaluating Saizen (somatropin) for safety and efficacy in children with Idiopathic Short Stature have been comp…
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CLINICAL_TRIALS trial_result · 2016-10-18Clinical Trial Update: Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature [Phase 3]
Phase 3 trial evaluating somatropin with leuprorelin versus somatropin alone in pubertal children with idiopathic short stature has complete…
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CLINICAL_TRIALS trial_result · 2016-10-05Clinical Trial Update: Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature [Phase 3]
Phase 3 trial evaluating the efficacy and safety of recombinant human growth hormone on height velocity in children with idiopathic short st…
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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 · 2016-03-24Clinical Trial Update: Efficacy and Safety Study of Sr-hGH in Comparison With Daily hGH in ISS Patients [Phase 2]
Phase 2 study comparing Sr-hGH to daily human growth hormone in idiopathic short stature to establish dosing and assess efficacy and safety;…
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FDA approval · 2016-03-17FDA Approved: NUTROPIN AQ NUSPIN 10 — Supplemental Application (Genentech, Inc.)
The FDA approved a supplemental application for Nutropin AQ Nuspin 10 (somatropin) by Genentech, Inc.
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FDA approval · 2015-06-12FDA Approved: ZOMACTON — Supplemental Application (Ferring Pharmaceuticals Inc.)
FDA approved a supplemental application for ZOMACTON (somatropin) from Ferring Pharmaceuticals, likely to update labeling or expand indicati…
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CLINICAL_TRIALS trial_result · 2015-05-29Clinical Trial Update: Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature [Phase 3]
Phase 3 trial completed evaluating the efficacy and safety of DA-3002 in children with idiopathic short stature, with results posted in 2015…
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CLINICAL_TRIALS trial_result · 2015-05-28Clinical Trial Update: Pappalysin 2 (PAPP-A2) Enzyme Replacement [Phase 1]
This update notes the completion of a Phase 1 clinical trial evaluating PAPP-A2 enzyme replacement therapy for idiopathic short stature.
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FDA approval · 2015-05-26FDA Approved: NUTROPIN AQ NUSPIN 10 — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for Nutropin AQ Nuspin 10 (somatropin) from Genentech, adding/confirming a formulation strength unde…
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CLINICAL_TRIALS trial_result · 2015-03-30Clinical Trial Update: Safety and Efficacy of Long-term Somatropin Treatment in Children
Clinical trial update reporting long-term safety and efficacy of somatropin treatment in pediatric patients with growth-related conditions.
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FDA approval · 2015-01-23FDA Approved: NORDITROPIN — Supplemental Application (Novo Nordisk)
FDA approved a supplemental application for Norditropin (somatropin) from Novo Nordisk, resulting in an approved supplemental indication/lab…
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CLINICAL_TRIALS research · 2014-12-02Clinical Trial Update: Constructing an Insulin-Like Growth Factor-based Prediction Model
The trial update describes efforts to construct an insulin-like growth factor–based predictive model for growth disorders (Growth Hormone De…
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CLINICAL_TRIALS trial_result · 2014-10-02Clinical Trial Update: Pharmacodynamics of CNP During Growth Hormone Treatment
An update on the pharmacodynamic effects of C-type natriuretic peptide during growth hormone treatment in children with pituitary dwarfism o…
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FDA approval · 2014-07-30FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)
The FDA approved a supplemental application for Humatrope (somatropin) from Eli Lilly and Company.
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CLINICAL_TRIALS trial_result · 2013-11-13Clinical Trial Update: Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature [Phase 3]
Pfizer-sponsored Phase 3 clinical trial evaluating an individualized, target-driven treatment approach in children with idiopathic short sta…
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FDA approval · 2013-04-19FDA Approved: GENOTROPIN — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA supplemental approval for Genotropin (somatropin) from Pfizer, authorizing an approved supplemental application to modify or expand its …
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FDA approval · 2013-04-04FDA Approved: OMNITROPE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Omnitrope (somatropin) from Sandoz Inc, potentially expanding or updating the product’s labe…
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CLINICAL_TRIALS trial_result · 2013-02-18Clinical Trial Update: Ghrelin Levels in Children With Poor Growth
A completed clinical trial investigated ghrelin levels in children with poor growth, including idiopathic short stature and failure to thriv…
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CLINICAL_TRIALS trial_result · 2013-01-03Clinical Trial Update: Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature [Phase 4]
This completed Phase 4 trial investigates biochemical markers related to growth hormone response in children with idiopathic short stature.
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CLINICAL_TRIALS trial_result · 2010-12-23Clinical Trial Update: Genotropin Study Assessing Use of Injection Pen [Phase 3]
Pfizer's Genotropin Phase 3 trial evaluating an injection pen for growth hormone deficiency and idiopathic short stature has completed, with…
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FDA approval · 2010-07-28FDA Approved: HUMATROPE — Supplemental Application (Eli Lilly and Company)
FDA approved a supplemental application for HUMATROPE (somatropin) submitted by Eli Lilly and Company, authorizing changes to the existing p…