Central Precocious Puberty
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CLINICAL_TRIALS trial_result · 2026-07-20Clinical Trial Update: Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty [Phase 3]
A Phase 3 clinical trial assessing efficacy, safety, and pharmacokinetics of leuprolide mesylate in children with central precocious puberty…
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CLINICAL_TRIALS trial_result · 2026-04-28Clinical Trial Update: A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial) [Phase 3]
A Phase 3 pediatric trial evaluating the efficacy, safety, and pharmacokinetics of Debio 4326 for central precocious puberty is currently AC…
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CLINICAL_TRIALS trial_result · 2026-03-30Clinical Trial Update: A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial) [Phase 3]
Phase 3 study assessing the efficacy, safety, and pharmacokinetics of Debio 4326 in pediatric participants with central precocious puberty; …
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CLINICAL_TRIALS research · 2026-03-12Clinical Trial Update: Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
A clinical trial update describing a study evaluating the frequency and diagnostic/developmental characteristics of idiopathic central preco…
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CLINICAL_TRIALS research · 2026-02-13Clinical Trial Update: Hypiend - Multicomponent Behavioral Intervention in Pre-puberal Children (Hypiend-PPC) [NA]
Clinical trial update for Hypiend-PPC, a multicomponent behavioral intervention for pre-pubertal children with central precocious puberty an…
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CLINICAL_TRIALS trial_result · 2026-01-22Clinical Trial Update: Spexin and Phoenixin-20 in Girls With Central Precocious Puberty
A completed clinical trial evaluating spexin and phoenixin-20 in girls with Central Precocious Puberty.
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CLINICAL_TRIALS trial_result · 2026-01-21Clinical Trial Update: A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China
This is a completed study analyzing medical records of children with central precocious puberty in China, sponsored by Takeda.
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CLINICAL_TRIALS trial_result · 2026-01-13Clinical Trial Update: A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty [Phase 4]
Phase 4 study of leuprolide acetate depot in children with central precocious puberty has completed and results have been posted.
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FDA approval · 2025-11-24FDA Approved: SYNAREL — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
FDA approved a supplemental application for Synarel (nafarelin acetate) submitted by Pfizer Laboratories Div Pfizer Inc. The approval update…
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FDA approval · 2025-11-14FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for LUPRON DEPOT-PED (leuprolide acetate) from AbbVie to support an expanded pediatric indication fo…
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FDA approval · 2025-09-23FDA Approved: TRELSTAR — Supplemental Application (Verity Pharmaceuticals Inc.)
FDA approved a supplemental application for TRELSTAR (triptorelin pamoate) from Verity Pharmaceuticals Inc., authorizing an updated indicati…
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FDA approval · 2025-09-23FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
FDA approved a supplemental application for Lupron Depot-PED (leuprolide acetate) from AbbVie, updating its labeling under a supplemental ap…
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FDA approval · 2025-09-23FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Eugia US LLC)
FDA approved a supplemental application for leuprolide acetate (generic) submitted by Eugia US LLC under an ANDA.
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FDA approval · 2025-09-23FDA Approved: SUPPRELIN LA — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for SUPPRELIN LA (histrelin acetate) from Endo USA, Inc., signaling an updated/expanded use or label…
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FDA label_change · 2025-09-23FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (NorthStar RxLLC)
FDA approved a supplemental application for Leuprolide acetate filed by NorthStar RxLLC, indicating an update to the product labeling.
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FDA label_change · 2025-09-23FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc)
FDA approved a supplemental application for Leuprolide acetate submitted by Meitheal Pharmaceuticals Inc.
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FDA approval · 2025-09-23FDA Approved: TRIPTODUR — Supplemental Application (Azurity Pharmaceuticals, Inc.)
The FDA approved a supplemental application for TRIPTODUR (triptorelin) from Azurity Pharmaceuticals, Inc.
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FDA approval · 2025-09-23FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Leuprolide acetate from Amneal Pharmaceuticals LLC, granting approval for a generic version of t…
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FDA approval · 2025-09-19FDA Approved: LEUPROLIDE ACETATE — Supplemental Application (Meitheal Pharmaceuticals Inc)
FDA approved a supplemental application for Leuprolide acetate from Meitheal Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2025-09-19Clinical Trial Update: Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty [Phase 3]
Phase 3 trial evaluating the efficacy, safety, and pharmacokinetics of leuprolide mesylate in children with Central precocious puberty.
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FDA approval · 2025-05-22FDA Approved: LUPRON DEPOT-PED — Supplemental Application (AbbVie Inc.)
The FDA approved a supplemental application for Lupron Depot-Ped (leuprolide acetate) from AbbVie Inc. The approval updates the product's la…
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CLINICAL_TRIALS trial_result · 2025-04-15Clinical Trial Update: Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty [Phase 4]
A Phase 4 clinical trial evaluates the efficacy and safety of Leuprolide Acetate 45 mg in subjects with Central precocious puberty. The stud…
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CLINICAL_TRIALS research · 2025-02-12Clinical Trial Update: Impact of the COVID-19 Pandemic on Central Precocious Puberty: a Retrospective Cohort Study from Turkey
A retrospective Turkish cohort study examining whether the COVID-19 pandemic impacted central precocious puberty.
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FDA approval · 2025-02-11FDA Approved: CAMCEVI — Supplemental Application (Accord BioPharma, Inc.)
FDA approved a supplemental application for CAMCEVI (leuprolide) from Accord BioPharma, Inc., expanding regulatory approval for this long-ac…
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CLINICAL_TRIALS trial_result · 2024-12-06Clinical Trial Update: Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty
The study evaluated whether basal luteinizing hormone (LH) can diagnose central precocious puberty as effectively as the peak LH after a sti…