Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Somapacitan (Sogroya, somapacitan-beco): what the evidence says

Name: Somapacitan (Sogroya, somapacitan-beco)
Published: 2026-10-27

At a glance

What it is: a modified human growth hormone with a small albumin-binding side chain, so it lasts much longer than standard GH. Approved as Sogroya (Aug 2020); the label covers adults with GH deficiency and children 2.5 years and older with GH deficiency, small-for-gestational-age short stature, Noonan syndrome or idiopathic short stature. ^{R1, R2}

What the evidence says: Human in children with GH deficiency (REAL4, 200 children), growth was non-inferior to standard short-acting GH. ^R3 In adults (REAL 1, 301 adults), it reduced truncal fat vs placebo. ^R4

Biggest risks: label warnings include hypersensitivity, possible tumor growth, impaired glucose tolerance and raised pressure in the skull. ^R2 Prohibited in sport. ^R5

Rating


Human Human evidence	Strong: phase 3 RCTs (n = 200; n = 301) ^{R3, R4}
Animal Animal / lab evidence	Not reviewed
Regulatory	FDA-approved ^R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R6, R7, R8} · prohibited at all times (WADA S2.2.3) ^R5
Established human dose	Yes, label dose (see Study details)

Evidence verdict: Child growth hormone deficiency: Strong (phase 3 RCT) · Adult growth hormone deficiency: Strong (phase 3 RCT) · Anti-aging or bodybuilding: No human data

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: well-run sponsor RCTs; long-term safety relies on decades of GH experience plus post-marketing data.

What is it?

Related pages: human-growth-hormone, tesamorelin, sermorelin.

Does it work?

Human REAL4 (children): height velocity 11.2 vs 11.7 cm/year with standard GH; non-inferior. ^{R3, R9}
Human REAL 1 (adults): truncal fat −1.53 percentage points vs placebo. ^{R4, R10}
⚪ Anti-aging or bodybuilding: no human data.

Is it safe?

Label warnings: hypersensitivity, neoplasm, glucose intolerance, intracranial hypertension. ^R2
Human Adverse events in trials were similar to standard GH. ^R3

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: FDA-approved, prescription (Sogroya). ^R1
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R6, R7, R8}
Sport: prohibited at all times; WADA names somapacitan under S2.2.3. ^R5

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
REAL4 2022	200 children with GH deficiency	SC	Weekly, per label	52 weeks	Height velocity 11.2 vs 11.7 cm/yr (standard GH)	PMID 36062966
REAL 1 2020	301 adults with GH deficiency	SC	Weekly, titrated	34 weeks	Truncal fat −1.53% vs placebo	PMID 32022863

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)

^R1 Drugs@FDA, Sogroya (somapacitan-beco), application BLA761156 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=BLA761156
^R2 Sogroya prescribing information, label published Feb 25, 2026 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eadd03b4-adc3-4b88-8a24-9d205c5b85aa
^R3 Miller BS, et al. J Clin Endocrinol Metab. 2022. PMID 36062966
^R4 Johannsson G, et al. J Clin Endocrinol Metab. 2020. PMID 32022863
^R5 WADA. The 2026 Prohibited List, S2.2.3, Growth Hormone (GH), its analogues and fragments, naming somapacitan. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R6 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R7 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R8 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R9 ClinicalTrials.gov NCT03811535, REAL4, children with GH deficiency, completed, 200 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT03811535
^R10 ClinicalTrials.gov NCT02229851, REAL 1, adults with GH deficiency, completed, 301 enrolled (CT.gov API v2, checked Oct 27, 2026). https://clinicaltrials.gov/study/NCT02229851

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Somapacitan (Sogroya, somapacitan-beco). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).