HGH (Human Growth Hormone) / Somatropin
Recombinant human growth hormone (somatropin)
Also known as: HGH, hGH, Somatropin, Somatrem (older recombinant), rhGH (recombinant human growth hormone), Genotropin, Humatrope, Norditropin, Saizen, Omnitrope, Zomacton, Serostim, Zorbtive, Sogroya (somapacitan, long-acting weekly), Skytrofa (lonapegsomatropin, long-acting weekly), Ngenla (somatrogon, long-acting weekly)
Evidence level: FDA-approved drug
What it is
HGH (human growth hormone, or somatropin) is the body's own growth hormone, made in the lab through recombinant DNA technology, and it's best known for driving growth, muscle, and metabolism. It's FDA-approved as a prescription drug under many brand names (Genotropin, Humatrope, Norditropin, and others) for specific medical conditions like growth hormone deficiency, Turner syndrome, and short bowel syndrome. It's larger and more complex than most compounds in this library, a 191-amino-acid hormone rather than a short peptide. It's not approved for anti-aging or athletic performance.
What the research found
Human growth hormone (HGH) replaces a hormone the body makes naturally, and it's FDA-approved for diagnosed growth-hormone deficiency; it's also pursued off-label for anti-aging and athletic performance. Decades of trials support replacement at approved doses for deficiency, where it has been associated with improved body composition and bone density. A historic 1990 trial in older men reported lean-mass gain and fat loss but also carpal tunnel, swelling, and glucose problems, and later guidelines recommend against off-label anti-aging use. The performance and anti-aging uses people pursue fall outside the approved indications and the trial evidence.
Status and regulatory position
FDA-approved under multiple biologics license applications (BLAs) across multiple branded products and indications — pediatric GH deficiency, adult GH deficiency, Turner syndrome, Prader-Willi syndrome, chronic renal insufficiency, SHOX deficiency, idiopathic short stature, Noonan syndrome, HIV-associated wasting (Serostim), short bowel syndrome (Zorbtive). Not FDA-approved for anti-aging or athletic performance. Federal regulation: distribution of HGH outside FDA-approved indications is criminalized under 21 USC 333(e) (Anabolic Steroid Control Act of 1990). HGH is not formally on DEA Schedule III (unlike testosterone) — it sits under a parallel but distinct federal-distribution-restriction framework that applies penalties analogous to those for Schedule III anabolic steroids when HGH is distributed for non-approved uses. WADA-banned in regulated sport — listed under Section S2.2.3 (Growth hormone, its analogues and fragments) of the 2026 Prohibited List, prohibited at all times. Currently FDA-approved products are prescription-only and dispensed through specialty pharmacies; research-community / off-label / black-market supply chains exist outside the FDA-approved channel and are illegal in the US under 21 USC 333(e).
Safety
HGH is FDA-approved and prescription-only for specific conditions; distributing it for non-approved uses is illegal under US federal law, and it is banned in regulated sport (WADA). VialWise is a research and educational reference, not medical advice — consult a licensed professional.
Disclosures
⚠️ For research and educational purposes only. HGH (somatropin) is FDA-approved as a prescription drug for specific FDA-approved indications (pediatric and adult GH deficiency, Turner syndrome, Prader-Willi syndrome, chronic renal insufficiency, SHOX deficiency, idiopathic short stature, Noonan syndrome, HIV-associated wasting, short bowel syndrome). Information in this entry is informational, not medical advice. Always confirm dose calculations with the in-app calculator and consult appropriate professional guidance before any protocol decisions. Use of HGH outside an FDA-approved indication is illegal under US federal law (21 USC 333(e)) and carries criminal as well as health-related consequences.
⚠️ HGH is a 191-amino-acid polypeptide hormone — technically a peptide but structurally distinct from the small peptides that dominate the rest of this library. This entry exists because researchers running peptide protocols frequently use HGH (alongside testosterone, GH-secretagogue stacks, GLP-1 agonists, AOD-9604, and other compounds covered elsewhere in this library). Mechanistically, HGH is the endogenous ligand at the GH receptor that the GHRH analogs (CJC-1295, sermorelin, tesamorelin) and GH secretagogues (Ipamorelin, MK-677) ultimately stimulate — exogenous HGH bypasses the upstream pituitary release pathway and acts directly. Researchers should be explicit with themselves about which compound class they are using.
⚠️ Federal distribution restrictions — different from testosterone's Schedule III but similar consequences. HGH (somatropin) is not formally classified under DEA Schedule III of the Controlled Substances Act. However, the Anabolic Steroid Control Act of 1990 amended the Federal Food, Drug, and Cosmetic Act to apply penalties analogous to Schedule III anabolic steroids to the distribution of human growth hormone, codified at 21 USC 333(e). Specifically, distribution of HGH for any use other than treatment of a disease or other recognized medical condition where such use has been authorized by the Secretary of Health and Human Services is a federal criminal offense, with penalties including up to 5 years imprisonment for a first offense and up to 10 years where the offense involves a person under 18. This means the legal framework for HGH is stricter in some respects than for testosterone — testosterone is Schedule III but has a broader range of legal off-label medical uses, while HGH's "FDA-approved indication" requirement is statutorily narrower. Distribution of HGH for anti-aging, athletic performance, body composition, or research-community use without an FDA-approved indication is illegal under federal law.
⚠️ Multiple FDA-approved products with substantially different reconstitution, dose units, and delivery devices. HGH is sold under 10+ FDA-approved branded products. The most common include: - Genotropin (Pfizer, cartridge + reconstitution + pen device) — most widely prescribed - Humatrope (Eli Lilly, cartridge + reconstitution + pen device) - Norditropin (Novo Nordisk, pre-filled solution pen — no reconstitution required, ready-to-inject) - Saizen (EMD Serono, cartridge + reconstitution + pen) — all presentations discontinued per the FDA Purple Book (BLA 019764); the licence stands but the product is no longer marketed - Omnitrope (Sandoz, cartridge + reconstitution + pen) - Zomacton (Ferring, vial + reconstitution + pen or syringe) - Serostim (EMD Serono, vial + reconstitution + syringe — specifically labeled for HIV-associated wasting) - Zorbtive (EMD Serono, vial + reconstitution — specifically labeled for short bowel syndrome) — discontinued per the FDA Purple Book (BLA 020604) - Long-acting weekly products (newer formulations): - Sogroya / somapacitan (Novo Nordisk, weekly SC) — albumin-binder modification. In Feb 2026 the FDA approved somapacitan for pediatric idiopathic short stature, small-for-gestational-age, and Noonan syndrome, giving it the broadest indication set among the long-acting GH products. - Skytrofa / lonapegsomatropin (Ascendis, weekly SC) — TransCon prodrug - Ngenla / somatrogon (Pfizer, weekly SC) — CTP modification The pharmacokinetics, dose units (mg vs IU), reconstitution requirements, and delivery devices differ substantially across these products. The Vialwise calculator's role for HGH is conversion of dose target (mg or IU) into draw volume at the labeled concentration — same architecture as the other peptide entries, but with brand-specific complexity around device-based delivery (pens) vs vial-and-syringe. Researchers should be explicit with themselves about which product they are using and follow that product's specific labeling.
⚠️ Three distinct dose contexts — different doses, different evidence bases, different regulatory contexts. HGH appears in three meaningfully distinct contexts: 1. FDA-approved indication treatment (TRT-equivalent for the GH axis) — adult GHD or pediatric GHD treatment per FDA labels. Dose ranges: ~ starting (adult);/day (pediatric). Goal: replacement to mid-normal IGF-1 range; titrated to symptoms, IGF-1 labs, and side effects (edema, joint pain, glucose tolerance). This is the FDA-approved use case and the use case supported by the largest RCT evidence base — primarily the Yuen 2019 AACE/ACE guideline framework[¹] and the Molitch 2011 Endocrine Society guideline.[²] 2. Off-label "anti-aging" use — operates outside the FDA-approved indication, outside DEA prescription authority, and outside the published RCT evidence base for that population. The Rudman 1990 NEJM trial[³] sparked an entire "anti-aging clinic" industry but reported significant side effects (carpal tunnel, gynecomastia, glucose intolerance) at supraphysiologic doses, and subsequent literature has not validated a clinical anti-aging benefit. Distribution of HGH for anti-aging is specifically illegal under 21 USC 333(e). 3. Research-community / performance use — supraphysiologic doses (typically) for athletic performance, body composition, or injury recovery; widely encountered in bodybuilding contexts. Operates outside the FDA-approved indication and outside the published RCT efficacy/safety data; explicitly illegal under federal law. Researchers should be explicit with themselves about which dose context applies and what evidence base + regulatory framework supports their specific use.
Quick reference
| Compound class | 191-amino-acid recombinant polypeptide hormone (somatropin). Technically a peptide; structurally a small protein. The endogenous ligand at the GH receptor. |
|---|---|
| Common product formats | Lyophilized cartridges + reconstitution (Genotropin, Humatrope, Omnitrope) + pen device; pre-filled solution pens (Norditropin); lyophilized vial + reconstitution + syringe (Zomacton, Serostim); weekly long-acting SC formulations (Sogroya, Skytrofa, Ngenla). Saizen, Zorbtive, Nutropin, Nutropin AQ and Accretropin are licensed but discontinued — every presentation is listed `Disc` in the FDA Purple Book, so they are not current supply options. |
| FDA-approved adult GHD dosing[¹][²][⁴][⁵] | Starting: ~ SC, no weight-based titration. Increase at 1–2 month intervals. Goal: mid-normal IGF-1 range; rarely exceeds. Some labels use weight-based starting (e.g., Genotropin/week → ~ for a 70 kg adult, divided into 6–7 daily SC injections). |
| FDA-approved pediatric GHD dosing[⁴] | /day SC (varies by product). Higher than adult dosing because pediatric indications target growth velocity. |
| Frequency | Daily SC (most products) or weekly SC (long-acting products). Daily dose typically given at bedtime to mimic endogenous nocturnal GH pulse. |
| Half-life | Free hGH (somatropin): ~20–30 minutes plasma half-life; biological effect (mediated by IGF-1 elevation) persists 12–24 hours. Long-acting analogues: ~1 week (somapacitan via albumin binding; lonapegsomatropin via TransCon prodrug; somatrogon via CTP modification). |
| Route | Subcutaneous (most products and indications). Intramuscular reported historically but rarely used in modern practice. |
| Onset of action | IGF-1 elevation detectable within 24 hours. Subjective effects on body composition typically observed at 4–8 weeks; full effect at 6–12 months in adult GHD trials. |
In depth
Somatropin (recombinant human growth hormone, rhGH) is a 191-amino-acid polypeptide hormone with the same primary structure as the endogenous human GH produced by the anterior pituitary. It is manufactured via recombinant DNA technology in *E. coli* or mammalian cell lines (varying by manufacturer) and is the standard-of-care GH replacement therapy for FDA-approved GH-deficiency and growth-disorder indications. Earlier extracted-from-cadaver pituitary GH was withdrawn from the market in 1985 after the discovery that it could transmit Creutzfeldt-Jakob disease; the recombinant somatropin that replaced it has been in continuous clinical use since 1985.
Endogenous role. GH is essential for childhood growth and lifelong metabolic homeostasis. Endogenous GH is released from anterior pituitary somatotrophs in pulsatile fashion (~10–20 pulses per 24 hours, with the largest pulse during early sleep). Plasma GH levels are highly variable; the clinically meaningful indicator of GH-axis activity is IGF-1 (insulin-like growth factor 1), which is produced by the liver in response to GH stimulation and has a much longer half-life (~12–18 hours), making it a more practical lab marker. Adult GH deficiency is diagnosed by GH-stimulation testing (insulin tolerance test, glucagon stimulation, macimorelin) plus IGF-1 measurement plus clinical features (per the Yuen 2019 AACE/ACE guideline framework[¹]).
Mechanism. HGH binds the GH receptor (GHR) on hepatocytes, adipocytes, myocytes, and other cells. Direct effects include lipolysis (visceral and subcutaneous), insulin antagonism (glucose elevation), and stimulation of IGF-1 production by the liver. Most of GH's anabolic effects are mediated by IGF-1, which acts on muscle, bone, and other tissues to produce growth and protein synthesis. The dual GH+IGF-1 effects are why supraphysiologic GH dosing produces both desired (lean mass, fat loss) and undesired (insulin resistance, joint pain, edema) outcomes.
Regulatory status (US — distinct from testosterone). HGH (somatropin) is not formally classified under DEA Schedule III of the Controlled Substances Act. However, the Anabolic Steroid Control Act of 1990 amended the Federal Food, Drug, and Cosmetic Act to apply penalties analogous to Schedule III anabolic steroids to the distribution of HGH, codified at 21 USC 333(e).[⁷] The statute reads (in summary): distribution of HGH "for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Secretary of Health and Human Services under section 505 [of the FFDCA] and pursuant to the order of a physician" is unlawful and carries criminal penalties. This means HGH distribution for anti-aging, athletic performance, body composition, or research-community use is a federal criminal offense in the US — distinct from testosterone (which IS on Schedule III, but where off-label medical use is broader because the controlled-substance framework allows physician discretion within accepted medical practice). The HGH framework is in practice more restrictive than testosterone's because it is anchored to FDA-approved indications specifically.
Regulatory status (sport — WADA). Somatropin is explicitly listed under Section S2.2.3 (Growth hormone, its analogues and fragments) of the 2026 WADA Prohibited List, prohibited at all times.[⁶] The S2.2.3 listing covers GH itself, named long-acting analogues (lonapegsomatropin, somapacitan, somatrogon), and growth hormone fragments (AOD-9604, hGH 176-191). All forms of recombinant or synthetic GH and its fragments fall under this prohibition.
FDA-approved indications. Adult and pediatric GH deficiency are the most common; additional FDA-approved indications include Turner syndrome, Prader-Willi syndrome, chronic renal insufficiency, SHOX deficiency, idiopathic short stature, Noonan syndrome, HIV-associated wasting (Serostim specifically), and short bowel syndrome (Zorbtive specifically — a licence that stands although the product is discontinued). The specific FDA-approved indications vary by product; not every brand is approved for every indication.[⁴][⁵]
Common research interests / off-label use. Despite the federal distribution restrictions, HGH is widely used outside FDA-approved indications:
- Anti-aging / "men's health" clinic use — driven by the Rudman 1990 NEJM trial.[³] The trial reported lean-mass gain (+4.7 kg) and fat-mass loss (-3.5 kg) in 12 elderly men over 6 months three times weekly, but also documented carpal tunnel syndrome, gynecomastia, and glucose-tolerance impairment. Subsequent literature has not validated long-term benefit and has consistently flagged side effects. The Yuen 2019 AACE/ACE guideline explicitly recommends against off-label HGH for anti-aging.[¹] - Athletic performance / bodybuilding use — supraphysiologic doses ( daily) for body composition and recovery. Operates entirely outside the FDA-approved indication, the published RCT evidence, and federal law. WADA-banned and a distribution offense under 21 USC 333(e). - Adjunct to peptide protocols — research-community use of HGH alongside testosterone, GH-secretagogue blends (CJC-1295/Ipamorelin), or GLP-1 agonists. Same regulatory framework as the above; same evidence-base limitations.
HGH vs GH secretagogues — the architectural distinction. Exogenous HGH bypasses the pituitary entirely — it acts directly at the GH receptor on peripheral tissues. GH secretagogues (CJC-1295, sermorelin, tesamorelin, Ipamorelin, MK-677) act upstream at the pituitary, stimulating endogenous GH release in pulsatile fashion. Practical consequences: - Pulsatility: GH secretagogues preserve the pulsatile pattern of endogenous GH; exogenous HGH produces a more sustained/continuous serum GH elevation that does not mimic the natural pulse pattern. - Negative feedback: GH secretagogues are subject to negative feedback (GH elevation → somatostatin release → GHRH suppression), producing a self-limiting effect; exogenous HGH bypasses feedback and can be dosed to supraphysiologic levels. - Side effect profile: supraphysiologic exogenous HGH produces more pronounced edema, joint pain, glucose-tolerance issues, and IGF-1-mediated effects than equivalent-IGF-1-elevation GH-secretagogue use. - Regulatory: HGH is restricted to FDA-approved indications under 21 USC 333(e); the unapproved GH secretagogues (CJC-1295, sermorelin, etc.) operate under the broader compounding-pharmacy / research-peptide regulatory framework.
Reported side effects
Commonly reported
- Edema / fluid retention — most common dose-limiting side effect; typically appears within first 1–2 weeks of initiation or dose escalation; resolves with dose reduction
- Arthralgia / joint pain — common; typically mild but can be dose-limiting
- Myalgia / muscle pain
- Carpal tunnel syndrome — described in trials and anti-aging literature; reflects fluid retention and IGF-1-mediated tissue effects
- Glucose intolerance / impaired insulin sensitivity — well-documented; HGH is glucose-elevating; routine glucose and HbA1c monitoring required
- Headache, fatigue — common during initial titration
- Injection site reactions — typically mild
- Lipoatrophy at injection sites — uncommon; mitigated by site rotation
- Idiopathic intracranial hypertension — uncommon but documented; fundoscopic exam recommended in pediatric initiation
- All of the above, more severe — particularly carpal tunnel and glucose intolerance
- Gynecomastia — driven by GH-mediated estradiol elevation and IGF-1 effects
- Acromegaly-like changes with prolonged supraphysiologic use — facial bone growth, hand/foot enlargement, jaw prominence; reported in long-term abuse contexts
- Cardiovascular concerns — sustained GH/IGF-1 elevation has been associated with left ventricular hypertrophy, increased cardiovascular morbidity, and atrial fibrillation in the acromegaly literature; researchers using supraphysiologic HGH long-term should be explicit with themselves about this risk profile
Serious
- Severe acute joint pain or new arthritis-like symptoms — possible synovial response to fluid retention
- Visual field changes, severe headache — possible idiopathic intracranial hypertension
- New-onset diabetes / severe hyperglycemia
- Acute pancreatitis symptoms
- New cardiovascular symptoms (chest pain, dyspnea, palpitations) — possible LV hypertrophy or arrhythmia
- Sudden visual changes — relevant in patients with prior pituitary disease
- Severe peripheral edema with shortness of breath — possible heart failure exacerbation
Contraindications and warnings
Active malignancy — IGF-1 elevation may promote cancer growth
Prader-Willi syndrome with severe obesity or severe respiratory impairment — fatalities reported in PWS patients with severe respiratory impairment treated with HGH
Acute critical illness — HGH treatment in ICU contexts associated with increased mortality (per pivotal trials in critically ill ICU populations)
Diabetic retinopathy — proliferative or non-proliferative; relative contraindication per most FDA labels
Hypersensitivity to somatropin or any product component
Closed epiphyses (in pediatric growth indications) — HGH for growth indications is ineffective once epiphyses are closed
Pregnancy — Category C (insufficient human data); discontinue during pregnancy
Pregnancy and lactation: discontinue. Safety not established.
Diabetes / impaired glucose tolerance: monitor glucose carefully; HGH worsens glucose tolerance
Concurrent corticosteroid use: may require corticosteroid dose adjustment; HGH affects cortisol metabolism
Active or recent malignancy: contraindicated — IGF-1 elevation may promote cancer progression
Regulatory note (US): Distribution of HGH outside FDA-approved indications is a federal crime under 21 USC 333(e). Penalties include up to 5 years imprisonment for first offenses; up to 10 years where the offense involves a person under 18.[⁷] This is a meaningfully different and in some respects stricter regulatory framework than testosterone's Schedule III status — testosterone allows broader medical discretion under the controlled-substance framework, while HGH is anchored specifically to FDA-approved indications.
Regulatory note (sport): Somatropin is explicitly listed in WADA 2026 Prohibited List Section S2.2.3 — prohibited at all times in regulated sport. WADA testing for exogenous GH uses both isoform-discrimination assays and biomarker-based panels.[⁶]
Key terms
- Peptide
- A short chain of amino acids, the building blocks of proteins. Many compounds in this library are peptides.
- Growth hormone
- the hormone that drives growth and metabolism, made by the pituitary gland.
- IGF-1
- a growth factor the liver makes in response to growth hormone; used as a lab marker (and, for igf-1 lr3, a growth factor that drives tissue and muscle growth).
- Subcutaneous
- An injection into the fatty layer just under the skin, rather than into a muscle or vein.
- WADA Prohibited List
- The list of substances banned in regulated sport by the World Anti-Doping Agency.
Sources
- Yuen KCJ, Biller BMK, Radovick S, Carmichael JD, Jasim S, Pantalone KM, Hoffman AR. (2019). American Association of Clinical Endocrinologists and American College of Endocrinology Guidelines for Management of Growth Hormone Deficiency in Adults and Patients Transitioning from Pediatric to Adult Care. Endocrine Practice, 25(11):1191–1232.(PMID 31760824)
- Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Vance ML; Endocrine Society. (2011). Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline. The Journal of Clinical Endocrinology & Metabolism, 96(6):1587–1609.(PMID 21602453)
- Rudman D, Feller AG, Nagraj HS, Gergans GA, Lalitha PY, Goldberg AF, Schlenker RA, Cohn L, Rudman IW, Mattson DE. (1990). Effects of human growth hormone in men over 60 years old. The New England Journal of Medicine, 323(1):1–6.(PMID 2355952)
- Pfizer. Genotropin (somatropin for injection) prescribing information. US Food and Drug Administration. BLA 020280, originally approved 1995; current label SUPPL-108 (2025).
- Novo Nordisk. Norditropin (somatropin) injection prescribing information. US Food and Drug Administration. BLA 021148, originally approved 2000; current label SUPPL-062 (2025).
- World Anti-Doping Agency. The 2026 Prohibited List, International Standard (effective 1 January 2026). Canonical PDF: wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf (linked from the WADA landing page; local archival copy in `docs/legal/wada-2026-prohibited-list.pdf`). Somatropin is named under Section S2.2.3 (Growth hormone, its analogues and fragments) — the same subsection that explicitly names AOD-9604, lonapegsomatropin, somapacitan, and somatrogon. Verbatim from the canonical PDF, page 8: "S2.2.3 Growth hormone (GH), its analogues and fragments including, but not limited to: growth hormone analogues, e.g. lonapegsomatropin, somapacitan and somatrogon; growth hormone fragments, e.g. AOD-9604 and hGH 176-191." Recombinant human GH (somatropin) falls under "growth hormone (GH)" itself; the named long-acting analogues and fragments are also covered. Prohibited at all times.
- US Code 21 USC 333(e) — Prohibited distribution of human growth hormone. Anabolic Steroid Control Act of 1990 (Pub. L. No. 101-647).
Related entries
- Testosterone — discussed together in this entry's stacks section
- Tesamorelin — discussed together in this entry's stacks section
- AOD-9604 — discussed together in this entry's stacks section
- IGF-1 LR3 — same mechanism class
- MGF — same mechanism class
- ACE-031 — shared research area
Entry last updated 2026-09-03. Sourced from published literature and regulatory labelling; see Sources above.