Drugs / Somatrogon
Somatrogon
also known as
MOD-4023 · Ctp-somatropin fusion protein · hGH · Ngenla · PF-06836922 · r-hGH · Somatrogon-ghla · Somatropin-ctp fusion protein
Protein / enzyme biologic targets GHR via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Ngenla | — | 2022-02-14 | europa.eu ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03810664 | Jan → Apr 2019 | — | OPKO Health, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02418767 | Jan → Mar 2015 | pituitary deficiency | OPKO Health, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01060722 | Oct 2009 → Jan 2010 | — | OPKO Health, Inc. | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT02500316 | Feb 2014 → Nov 2023 | pituitary deficiency | OPKO Health, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01592500 | Feb 2012 → Jul 2015 | non-acquired pituitary hormone deficiency | OPKO Health, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01225666 | Aug 2010 → Jul 2011 | pituitary deficiency | OPKO Health, Inc. | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT07226089 | Feb 2026 → Dec 2027 expected | fetal growth restriction | Rabin Medical Center | Recruiting | No outcome recorded |
| Phase 3 | NCT03831880 | Feb 2019 → Aug 2020 | pituitary deficiency | Pfizer | Completed | Met primary |
| Phase 3 | NCT03874013 | Dec 2017 → Mar 2020 | pituitary deficiency | OPKO Health, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02968004 | Dec 2016 → Aug 2019 | non-acquired pituitary hormone deficiency | OPKO Health, Inc. | Completed | Met primary |
| Phase 3 | NCT01909479 | Jun 2013 → Aug 2016 | pituitary deficiency | OPKO Health, Inc. | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2023-06-28 | OPKO Health, Inc. | Regulatory FDA Approves Pfizer’s NGENLA™, a Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency opko.com ↗ |
| 2022-02-15 | Pfizer | Regulatory Pfizer and OPKO’s Once-Weekly NGENLA™ (somatrogon) Injection Receives Marketing Authorization in European Union for Treatment of Pediatric Growth Hormone Deficiency pfizer.com ↗
The marketing authorization of NGENLA is valid in all EU Member States as well as Iceland, Norway and Liechtenstein. |
| 2022-02-15 | OPKO Health, Inc. | Regulatory Pfizer and OPKO’s Once-Weekly NGENLATM (somatrogon) Injection Receives Marketing Authorization in European Union for Treatment of Pediatric Growth Hormone Deficiency opko.com ↗
Pfizer and OPKO’s Once-Weekly NGENLA TM (somatrogon) Injection Receives Marketing Authorization in European Union for Treatment of Pediatric Growth Hormone Deficiency |
| 2022-01-21 | Pfizer | Regulatory Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiency pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon. |
| 2022-01-21 | OPKO Health, Inc. | Regulatory Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiency opko.com ↗
Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon. |
| 2022-01-20 | OPKO Health, Inc. | Regulatory JAPAN’S MHLW APPROVES PFIZER AND OPKO’S NGENLA® (SOMATROGON), A NEW LONG-ACTING TREATMENT FOR PEDIATRIC GROWTH HORMONE DEFICIENCY opko.com ↗
Pfizer Japan Inc. and OPKO Health, Inc. (NASDAQ: OPK) announced today that the next generation long-acting growth hormone injection, NGENLA ® (somatrogon) Inj. 24 mg Pens and 60 mg Pens, has been approved by the Ministry of Health, Labour and Welfare (MHLW) in Japan. |
| 2021-12-17 | Pfizer | Regulatory 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 | Regulatory Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency pfizer.com ↗
The Prescription Drug User Fee Act (PDUFA) goal date has been extended by three months to January 2022, as a result of Pfizer’s submission of additional data to the original BLA. |
| 2021-09-24 | OPKO Health, Inc. | Regulatory Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency opko.com ↗ |
| 2021-02-26 | OPKO Health, Inc. | Regulatory EMA Accepts Marketing Application for Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency opko.com ↗
Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for somatrogon, a long-acting recombinant human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD). |
| 2021-01-28 | OPKO Health, Inc. | Regulatory New Drug Application Submitted to PMDA in Japan for Somatrogon, to Treat Pediatric Patients with Growth Hormone Deficiency opko.com ↗ |
| 2021-01-04 | Pfizer | Regulatory US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the US Food and Drug Administration (FDA) has accepted for filing the initial Biologics License Application (BLA) for somatrogon, a long-acting human growth hormone that is intended to be administered once-weekly for the treatment of pediatric patients with growth hormone deficiency (GHD). |
| 2021-01-04 | OPKO Health, Inc. | Regulatory US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency opko.com ↗ |
| 2020-10-08 | Pfizer | Results 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 ↗
Top-line results from the study demonstrated that treatment with somatrogon once-weekly improved the mean overall Life Interference total score after 12 weeks of treatment (8.63) compared to treatment with somatropin administered once-daily (24.13). |
| 2020-10-08 | OPKO Health, Inc. | Results Pfizer Announces Positive Phase 3 Top-line Results for Once-Weekly Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency opko.com ↗
Top-line results from the study demonstrated that treatment with somatrogon once-weekly improved the mean overall Life Interference total score after 12 weeks of treatment (8.63) compared to treatment with somatropin administered once-daily (24.13). |
| 2020-06-09 | OPKO Health, Inc. | Results OPKO Health Announces Positive Top-Line Results of Phase 3 Efficacy and Safety Study of Somatrogon for the Treatment of Japanese Children with Growth Hormone Deficiency opko.com ↗
Using the Full Analysis Set, the least squared means for the annual height velocity was higher in the somatrogon group (9.65 cm/year) than in the GENOTROPIN group (7.87 cm/year). |
| 2019-10-21 | Pfizer | Results 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 ↗
Top-line results from the study demonstrated that treatment with somatrogon dosed once-weekly in pre-pubertal children with GHD was non-inferior to somatropin dosed once-daily with respect to height velocity at 12 months of treatment (the primary endpoint); |
| 2019-10-21 | OPKO Health, Inc. | Results 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 opko.com ↗
In addition, change in height standard deviation scores at six and 12 months, key secondary endpoints, were higher in the somatrogon dosed once-weekly cohort in comparison to the somatropin dosed once-daily cohort. |
All press releases naming this drug 24 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Somatrogon | “Subjects will be randomized to one of two sequences, either 12 weeks of continued treatment with daily Genotropin followed by 12 weeks of treatment with weekly somatrogon, or...” NCT03831880 ↗ |
| Known as | Ctp-somatropin fusion protein | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297830 ↗ |
| Known as | hGH | “Pharmacokinetics and Pharmacodynamics of Long Acting Human Growth Hormone (hGH) Product (MOD-4023) in Healthy Caucasian and Japanese Volunteers” NCT02418767 ↗ |
| Known as | MOD-4023 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02500316 ↗ |
| Known as | Ngenla | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297830 ↗ |
| Known as | PF-06836922 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297830 ↗ |
| Known as | r-hGH | “Once weekly injection of long acting r-hGH (MOD-4023) provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a single patient use, multi-dose, disposable...” NCT02500316 ↗ |
| Known as | Somatrogon-ghla | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297830 ↗ |
| Known as | Somatropin-ctp fusion protein | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297830 ↗ |
| Action | Activate | “Growth hormone receptor agonist” CHEMBL4297830 ↗ |
| Modality | Protein / enzyme biologic | “a long acting Human Growth Hormone (hGH) Product (MOD-4023)” NCT01060722 ↗ |
| Route | Subcutaneous | “Single subcutaneous dose of MOD-4023” NCT01060722 ↗ |
| Target | GHR | “Growth hormone receptor agonist” CHEMBL4297830 ↗ |