|NCT01706783||A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency||Phase 1||Completed||2018-05-25|
|NCT01973244||A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency||Phase 1||Completed||2018-05-25|
|NCT02962440||A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects||Phase 1||Completed||2017-06-07|
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FDA APPROVED, 2020/8/28, SOGROYA
Growth hormone (GH) receptor agonist
Treatment of growth hormone dificiency
albumin-binding growth hormone
UNII-F1 component VTUYEWRWJTWXPQ-IWWWZYECSA-N
Somapacitan, also known as NNC0195-0092,3 is a growth hormone analog indicated to treat adults with growth hormone deficiency.2,6 This human growth hormone analog differs by the creation of an albumin binding site, and prolonging the effect so that it requires weekly dosing rather than daily.5
Somapacitan was granted FDA approval on 28 August 2020.7
Somapacitan, sold under the brand name Sogroya, is a growth hormone medication. Somapacitan is a human growth hormone analog. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology.
The most common side effects include: back pain, joint paint, indigestion, a sleep disorder, dizziness, tonsillitis, swelling in the arms or lower legs, vomiting, adrenal insufficiency, hypertension, increase in blood creatine phosphokinase (a type of enzyme), weight increase, and anemia.
It was approved for medical use in the United States in August 2020.
Somapacitan (Sogroya) is the first human growth hormone (hGH) therapy that adults only take once a week by injection under the skin; other FDA-approved hGH formulations for adults with growth hormone deficiency must be administered daily.
Somapacitan is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency.
Somapacitan should not be used in people with active malignancy, any stage of diabetic eye disease in which high blood sugar levels cause damage to blood vessels in the retina, acute critical illness, or those with acute respiratory failure, because of the increased risk of mortality with use of pharmacologic doses of somapacitan in critically ill individuals without growth hormone deficiency.
Somapacitan was evaluated in a randomized, double-blind, placebo-controlled trial in 300 particpants with growth hormone deficiency who had never received growth hormone treatment or had stopped treatment with other growth hormone formulations at least three months before the study. Particpants were randomly assigned to receive injections of weekly somapacitan, weekly placebo (inactive treatment), or daily somatropin, an FDA-approved growth hormone. The effectiveness of somapacitan was determined by the percentage change of truncal fat, the fat that is accumulated in the trunk or central area of the body that is regulated by growth hormone and can be associated with serious medical issues.
At the end of the 34-week treatment period, truncal fat decreased by 1.06%, on average, among particpants taking weekly somapacitan while it increased among particpants taking the placebo by 0.47%. In the daily somatropin group, truncal fat decreased by 2.23%. Particpants in the weekly somapacitan and daily somatropin groups had similar improvements in other clinical endpoints.
It was approved for medical use in the United States in August 2020. The U.S. Food and Drug Administration (FDA) granted the approval of Sogroya to Novo Nordisk, Inc.
- ^ Jump up to:a b c d “Sogroya (somapacitan-beco) injection, for subcutaneous use” (PDF). Retrieved 1 September 2020.
- ^ Jump up to:a b c d e f g h i j k l m n o “FDA approves weekly therapy for adult growth hormone deficiency”. U.S. Food and Drug Administration (FDA) (Press release). 1 September 2020. Retrieved 1 September 2020. This article incorporates text from this source, which is in the public domain.
- ^ “FDA approves once-weekly Sogroya for the treatment of adult growth hormone deficiency”. Novo Nordisk (Press release). 28 August 2020. Retrieved 1 September 2020.
- ^ Jump up to:a b c “Sogroya: FDA-Approved Drugs”. U.S. Food and Drug Administration (FDA). Retrieved 2 September 2020.
- “Somapacitan”. Drug Information Portal. U.S. National Library of Medicine.
|Other names||somapacitan-beco, NNC0195-0092|
|Drug class||Human growth hormone analog|
|Chemical and physical data|
|Molar mass||23305.42 g·mol−1|
|NCT02616562||Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency||Phase 2||Recruiting||2020-03-25|
|NCT03075644||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 Japanese Adults With Growth Hormone Deficiency||Phase 3||Completed||2019-10-18|
|NCT03905850||A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects||Phase 1||Completed||2019-08-06|
|NCT03212131||Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.||Phase 1||Completed||2019-05-24|
|NCT01514500||First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects||Phase 1||Completed||2018-05-25|
|NCT03811535||A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day||Phase 3||Recruiting||2020-09-03|
|NCT03878446||A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day||Phase 2||Recruiting||2020-08-27|
|NCT02382939||A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency||Phase 3||Completed||2020-07-09|
|NCT02229851||Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.||Phase 3||Completed||2020-07-07|
|NCT03186495||Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function||Phase 1||Completed||2020-04-17|
EU Clinical Trials Register
|2018-000232-10||A dose-finding trial evaluating the effect and safety of once-weekly treatment of somapacitan compared to daily Norditropin® in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older||Phase 2||Ongoing, Prematurely Ended||2019-05-15|
|2015-000531-32||A randomised, multinational, active-controlled,(open-labelled), dose finding, (double-blinded), parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency||Phase 2||Ongoing, Completed||2015-12-10|
|2014-000290-39||A multicentre, multinational, randomised, open-labelled, parallel-group, active-controlled trial to compare the safety of once weekly dosing of NNC0195-0092 with daily Norditropin® FlexPro® for 26 weeks in previously human growth hormone treated adults with growth hormone deficiency||Phase 3||Completed||2014-11-07|
|2013-002892-16||A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, followed by a 53-week open-label extension period||Phase 3||Completed||2014-10-07|
|2018-000231-27||A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin® in children with growth hormone deficiency||Phase 3||Ongoing|
EU Clinical Trials Register
|2013-000013-20||A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency||Phase 1||Ongoing, Completed||2013-12-09|
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