Drugs / somapacitan
somapacitan
also known as
NN-8640 · NNC0195-0092 · Sogroya · Sogroya (Somapacitan-beco injections) · somapacitan-beco
Protein / enzyme biologic targets GHR via activation
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | SOGROYA | — | 2023-04-28 – 2026-02-27 | fda.gov ↗ |
| Approved | EU (EMA) | Sogroya | — | 2021-03-31 | europa.eu ↗ |
| Approved | US (FDA) | SOGROYA | — | 2020-08-28 | fda.gov ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06803589 | Oct 2024 → Oct 2027 expected | gastroparesis | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 17 trials | ||||||
| Phase 1 | NCT03905850 | Mar → Jul 2019 | pituitary deficiency | Novo Nordisk A/S | Completed | Mixed |
| Phase 1 | NCT03212131 | Aug 2017 → Mar 2018 | pituitary deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03186495 | Jun 2017 → May 2018 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT02962440 | Nov 2016 → Jan 2017 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01973244 | Dec 2013 → Nov 2014 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01706783 | Oct 2012 → Nov 2013 | — | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01514500 | Jan 2012 → Mar 2013 | pituitary deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT03878446 | Jul 2019 → May 2021 overdue | fetal growth restriction | Novo Nordisk A/S | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02616562 | Mar 2016 → Sep 2024 | pituitary deficiency | Novo Nordisk A/S | Completed | Missed primary |
| Phase 37 trials · 3 met primary | ||||||
| Phase 3 | NCT05723835 | Feb 2023 → Jun 2024 overdue | Noonan syndrome, Turner syndrome, fetal growth restriction | Novo Nordisk A/S | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05330325 | Aug 2022 → Aug 2024 overdue | Noonan syndrome, Turner syndrome, isolated short stature | Novo Nordisk A/S | Active not recruiting | Met primary |
| Phase 3 | NCT04970654 | Jul 2021 → Nov 2023 | pituitary deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT03811535 | May 2019 → Nov 2021 | pituitary deficiency | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT03075644 | Mar 2017 → Oct 2018 | pituitary deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT02382939 | Feb 2015 → Jan 2016 | pituitary deficiency | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 3 | NCT02229851 | Oct 2014 → Apr 2017 | pituitary deficiency | Novo Nordisk A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Novo Nordisk A/S | Regulatory Novo’s once-weekly Sogroya® (somapacitan) receives positive CHMP opinion in Europe for children with idiopathic short stature (unexplained shortness) novonordisk.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended once-weekly Sogroya® (somapacitan) for children in Europe living with idiopathic short stature (ISS) with persistent growth disturbance. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Novo Nordisk A/S | Novo’s once-weekly Sogroya® (somapacitan) receives positive CHMP opinion in Europe for children with idiopathic short stature (unexplained shortness) novonordisk.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | somapacitan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02616562 ↗ |
| Known as | NN-8640 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707290 ↗ |
| Known as | NNC0195-0092 | “A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated...” NCT03075644 ↗ |
| Known as | Sogroya | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707290 ↗ |
| Known as | Sogroya (Somapacitan-beco injections) | “Sogroya (Somapacitan-beco injections)” NCT06803589 ↗ |
| Known as | somapacitan-beco | “Subjects will receive somapacitan-beco (Sogroya®) administered as a subcutaneous injection once weekly for 12 weeks.” NCT06803589 ↗ |
| Action | Activate | “Growth hormone receptor agonist” CHEMBL3707290 ↗ |
| Modality | Protein / enzyme biologic | “Somapacitan, a long-acting growth hormone (GH) derivative” PMID 29671202 ↗ Jan 2019 |
| Route | Subcutaneous | “A single dose administered subcutaneously (s.c., under the skin)” NCT01973244 ↗ |
| Target | GHR | “Growth hormone receptor agonist” CHEMBL3707290 ↗ |