Drugs / Somatotropin

Trials 5

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT01576861 Jan 2007 → Mar 2011 heart failure, pituitary deficiency Federico II University Completed No outcome recorded
Phase 2 NCT00591760 Dec 2004 → Nov 2007 ischemic disease, pituitary deficiency, systolic heart failure Federico II University Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT05602090 Feb 2022 → Sep 2023 ovarian dysfunction Beni-Suef University Unknown No outcome recorded
Phase 41 trial
Phase 4 NCT00458263 Apr 2006 → May 2011 isolated short stature Rabin Medical Center Completed No outcome recorded
Phase not applicable1 trial
— NCT01367834 May 2010 → May 2014 Turner syndrome Rebecca Knickmeyer Santelli, PhD Completed No outcome recorded
Comparator or background therapy2 trials
Phase 2 NCT00533221 Comparator Oct 2007 → Feb 2010 spinal muscular atrophy University Hospital Freiburg Completed No outcome recorded
Phase 3 NCT02736591 Comparator Jun 2016 → Apr 2017 infertility disorder Cairo University Unknown No outcome recorded

Press releases naming this drug 10 releases

DateIssuerRelease
2023-06-28 Pfizer FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency pfizer.com ↗
2022-02-15 Pfizer Pfizer and OPKO’s Once-Weekly NGENLA™ (somatrogon) Injection Receives Marketing Authorization in European Union for Treatment of Pediatric Growth Hormone Deficiency pfizer.com ↗
2022-01-21 Pfizer Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiency pfizer.com ↗
2021-12-17 Pfizer EMA Adopts a Positive CHMP Opinion for Pfizer’s and OPKO’s Somatrogon, a Long-Acting Treatment for Pediatric Growth Hormone Deficiency pfizer.com ↗
2021-09-24 Pfizer Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency pfizer.com ↗
2021-04-06 Entera Bio Ltd. New Data Suggest Entera’s Platform Orally Delivers Human Growth Hormone, Study Results to be Presented at European Pharma Congress enterabio.com ↗
2021-02-26 Pfizer EMA Accepts Marketing Application for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency pfizer.com ↗
2021-01-04 Pfizer US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency pfizer.com ↗
2020-10-08 Pfizer Pfizer Announces Positive Phase 3 Top-line Results for Once-Weekly Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency pfizer.com ↗
2019-10-21 Pfizer OPKO and Pfizer Announce Positive Phase 3 Top-Line Results for Somatrogon, an Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency pfizer.com ↗

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as Somatotropin “Growth hormone (Somatotropin, Sedico, Egypt) 4 IU on day 6 of hMG stimulation in a daily dose of 2.5 mg SC until the day of hCG triggering.” NCT02736591 ↗
6

NCT01367834 ↗

NCT00533221 ↗

NCT00458263 ↗

NCT01576861 ↗

NCT05602090 ↗

NCT00591760 ↗

Known as Growth hormone “Growth hormone in this trial will use 4 IU of recombinant GH (Somatotropin, ) by day after day subcutaneous injection for 6 weeks before starting cycle.” NCT05602090 ↗
1

“Growth hormone (Somatotropin, Sedico, Egypt) 4 IU on day 6 of hMG stimulation in a daily dose of 2.5 mg SC until the day of hCG triggering.” NCT02736591 ↗

Known as growth hormone recombinant human “Somatotropin growth hormone recombinant human” NCT00458263 ↗
Known as recombinant Human Growth Hormone “Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day” NCT01576861 ↗
Action Restore “correction of growth hormone (GH) deficiency with GH replacement therapy” NCT00591760 ↗
Modality Protein / enzyme biologic “Somatotropin growth hormone recombinant human” NCT00458263 ↗
Route Subcutaneous “daily Sub Cutaneous injections” NCT00458263 ↗