SOGROYA (somapacitan-beco)
SOGROYA is indicated for the treatment of Growth Hormone Deficiency; Growth Failure.
How SOGROYA Works
Somapacitan-beco works by binding to a dimeric growth hormone receptor on the cell membrane of target cells. This interaction initiates intracellular signal transduction, resulting in a variety of pharmacodynamic effects. These effects are achieved either through the direct action of the drug or are mediated by insulin-like growth factor-1 (IGF-1) produced in the liver.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-08-28
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
SOGROYA Approval History
What SOGROYA Treats
2 indicationsSOGROYA is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Growth Hormone Deficiency
- Growth Failure
SOGROYA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SOGROYA
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05330325 REAL 8 | NN8640-4467 2021-005607-13, U1111-1270-0862 | Ph 3 | active not recruiting | A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow |
| NCT02616562 results posted | NN8640-4172 2015-000531-32, U1111-1166-7062 | Ph 2 | completed | 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 |
| NCT03811535 REAL4 results posted | NN8640-4263 U1111-1207-9691, 2018-000231-27 | Ph 3 | completed | 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 (REAL4) |
| NCT04970654 results posted | NN8640-4468 U1111-1250-7530, 2020-002974-28 | Ph 3 | completed | A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day. |
| NCT03878446 results posted | NN8640-4245 U1111-1207-9741, 2018-000232-10 | Ph 2 | active not recruiting | A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day |
| NCT05723835 REAL 9 results posted | NN8640-4469 U1111-1277-9765, 2022-501055-87 | Ph 3 | active not recruiting | A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9 |
| NCT01514500 | NN8640-3915 U1111-1119-0539, 2011-000146-38 | Ph 1 | completed | First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects |
| NCT01973244 | NN8640-4042 2013-000013-20, U1111-1138-2206 | Ph 1 | completed | 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 |
| NCT01706783 | NN8640-3947 2011-005484-24, U1111-1125-7331 | Ph 1 | completed | 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 |
| NCT02229851 REAL 1 results posted | NN8640-4054 2013-002892-16, U1111-1145-0211 | Ph 3 | completed | Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. |
| NCT03075644 results posted | NN8640-4244 U1111-1181-1618, JapicCTI-173534 | Ph 3 | completed | 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 |
| NCT02382939 REAL 2 results posted | NN8640-4043 2014-000290-39, U1111-1152-3664 | Ph 3 | completed | 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 |
| NCT03186495 | NN8640-4297 U1111-1187-9141, 2016-003910-29 | Ph 1 | completed | 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 |
| NCT03905850 | NN8640-4491 2018-003670-27, U1111-1220-5197 | Ph 1 | completed | A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects |
| NCT03212131 | NN8640-4298 U1111-1187-9247, 2016-003911-36 | Ph 1 | completed | 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. |
| NCT02962440 | NN8640-4237 2016-000096-24, U1111-1178-1251 | Ph 1 | completed | A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOGROYA FDA Label Details
Indications & Usage
FDA Label (PDF)SOGROYA is indicated for the treatment of Growth Hormone Deficiency; Growth Failure.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment