HGH
somatropin
StatusFDA approved · prescription
PeptideHound Staff · Last editorially reviewed · 22 sources
HGH is human growth hormone, and what is sold under that name is a manufactured copy called somatropin on a pharmacy label: a prescription medicine with a large, genuine approval record that is far narrower than most searchers expect. Every approval names a diagnosis, and none of those diagnoses is ageing, muscle or sport.
The strongest evidence sits in children whose bodies do not make enough of the hormone. The heiGHt trial was a randomised, open-label, active-controlled, 52-week Phase 3 trial in 161 treatment-naive, prepubertal patients with growth hormone deficiency, and annualised height velocity at 52 weeks was 11.2 cm/year on a once-weekly version against 10.3 cm/year on daily somatropin. A second phase 3 programme randomised 228 prepubertal children and measured the same thing the same way.
Behind the trials sits one of the largest treatment registries in endocrinology: 83,803 children, followed for a median of 2.7 years, every one of them carrying a growth disorder. Two further approvals cover adults, for short bowel syndrome and for wasting in HIV, and both of those are diagnoses as well. The one approval that mentions lean body mass at all ties it to an illness.
The practical reality is that this is a pharmacy medicine with an enforcement history. FDA recall records list somatropin injections as prescription only, and the same records hold eight recalls between 2012 and 2021, covering sterility, silicone oil in a freeze-dried vial, injector pens breaking apart, and a carton packed with the wrong part.
Evidence: FDA approved for named diagnoses · phase 3 randomised trials in children with growth hormone deficiency · registry of 83,803 treated children · published follow-up to six years · no published trial in healthy adults · material bought outside a pharmacy carries no label and no approval
What is HGH?
review
HGH stands for human growth hormone. The body makes its own; the material sold under that name is a manufactured copy, with a different name on a pharmacy label. A 2004 review describes a somatropin preparation (Zorbtive) produced by recombinant DNA technology, which is the route every version shares.1 Several forms now exist. A 2022 review describes lonapegsomatropin as a long-acting prodrug of somatropin (human growth hormone), meaning a form that holds the hormone and releases it slowly.2 A 2011 review adds a third kind, recording that biosimilars of recombinant somatropin have gained market authorisation in the EU.3 A biosimilar is an approved copy of a biological medicine. So the word on the box can mean daily somatropin, a long-acting version, or a copy of either. What they share is the hormone itself, made in a factory rather than in a gland.
Is HGH a peptide?
review
People search for HGH and for peptides as if the two sat in one category. They do not. Growth hormone is a biological medicine, a class a 2011 review defines as biological medicinal products referring to an existing biological originator product.3 The difference is regulatory before it is chemical, and it is why this page can quote approval dates at all. The same review notes that the European Medicines Agency (EMA) has issued guidelines that should be fulfilled in order to receive approval as biosimilar.3 An approved copy has to clear that bar. None of it travels to a vial of something else. Material sold as an HGH fragment, or as a growth-hormone releasing peptide, is a different molecule, and this page does not describe it.
What is HGH approved for?
review
Approval is a fact about a named product and a named diagnosis, and growth hormone has several of each. For children, a 2022 review records that lonapegsomatropin received its first approval in August 2021 in the USA for pediatric patients at least 1 year of age with growth failure due to inadequate secretion of endogenous growth hormone.2 Two further indications cover adults. A 2014 review states that recombinant growth hormone (somatropin) is now approved for clinical use in patients with short bowel syndrome (SBS).4 And a 2006 review states that somatropin derived from mammalian cells (Serostim) is the only US FDA-approved treatment indicated to increase lean body mass, bodyweight and physical endurance in HIV-associated wasting.56 Read that last line slowly. It is the only approval in the record that mentions lean body mass at all, and it is tied to an illness.
Does that approval cover anti-ageing or performance use?
review
No, and the gap is not a technicality. Line the three indications up and every one names a condition somebody has been diagnosed with. The first covers children whose own growth hormone secretion is inadequate. The second covers patients with short bowel syndrome, which follows surgical removal of part of the intestine. The third covers wasting in HIV, where a 2006 review of these patients notes that loss of body cell mass, a component of lean body mass, is associated with decreased survival.5 Every one of those approvals names a deficiency or a disease, and none of them covers a healthy adult taking growth hormone for ageing, muscle or athletic performance. The lean body mass finding quoted elsewhere was measured against placebo in people losing weight to an illness, rather than in anyone healthy. Putting mass back onto a wasting patient and adding mass to a well adult are different questions, and only the first has an answer.
How far into human testing has HGH gone?
human RCT
Further than almost anything else covered on this site, and in one direction only. The heiGHt trial was a randomized, open-label, active-controlled, 52-week Phase 3 trial, and it enrolled and dosed 161 treatment-naive, prepubertal patients with GHD.7 A separate phase 3 programme randomised 228 prepubertal children with growth hormone deficiency, and a Japanese trial of the same design enrolled 44 prepubertal Japanese children with GHD.89 Behind them sits a registry nobody in this field can match. The Kabi/Pfizer International Growth Database (KIGS) is a large, international database (1987-2012) of children treated with recombinant human growth hormone (rhGH) in real-world settings, and its full cohort runs to 83,803 patients followed for a median of 2.7 years.10 Now read what that scale is made of. It is children with growth disorders, watched for years by the clinics prescribing to them, rather than volunteers curious about the hormone.
Does HGH work in the conditions it was approved for?
human RCT
In children with growth hormone deficiency the answer is yes, and the measurement is height. In the heiGHt trial, mean AHV at 52 weeks was 11.2 cm/year for lonapegsomatropin vs 10.3 cm/year for daily somatropin (P = 0.009).7 AHV is annualised height velocity, the centimetres a child gains in a year. Weekly and daily land close together. In the somatrogon trial, HV at month 12 was 10.10 cm/year for somatrogon-treated subjects and 9.78 cm/year for somatropin-treated subjects.8 Notice what that compares: nobody randomised a child with a hormone deficiency to no hormone at all, so these trials answer how often rather than whether.9 The longest published follow-up ran six years. In the enliGHten extension trial, mean height SDS (-0.39 at year 4, n = 298) approached the mean for children of average stature, and 48 of the 81 participants who finished met or exceeded their average parental height SDS at their last visit.11 That is the shape of it: a diagnosed shortfall, corrected over years, judged against how tall the child was expected to be.
What else has HGH been studied in?
review
Three other populations appear in the published record. Each was chosen because something was already wrong. In short bowel syndrome the outcome was feeding through a vein. A 2004 review describes a double-blind study in patients with short bowel syndrome who were dependent on intravenous parenteral nutrition (IPN) [n = 41], in which somatropin recipients had significantly greater mean reductions from baseline in weekly total IPN volume than recipients of placebo plus glutamine.1 In HIV-associated wasting the outcome was physical capacity. A 2006 review reports that somatropin increased work output, bodyweight and lean body mass against placebo in those patients.5 The third is short stature with no hormone shortfall behind it. A 2025 registry analysis is blunt that GH treatment in children with idiopathic short stature (ISS) can be controversial.12 Even the contested use is a question about a child's height, rather than anything an adult came here for.
Does HGH build muscle?
human pilot / early trial
One published finding speaks to this, and it comes from people who were ill. A 2006 review records that somatropin from mammalian cells is the only US FDA-approved treatment indicated to increase lean body mass, bodyweight, and physical endurance in HIV-associated wasting, and in a large randomised study in those patients it increased work output, bodyweight and lean body mass against placebo.65 That is a real result and it is not the result people are looking for. It describes mass returning to patients who had been losing it, measured against placebo inside that illness, rather than mass added to someone who is healthy. Those are different questions, and the second has not been asked in anything published under these approvals. Nothing in a registry of 83,803 children treated for growth disorders measures what a trained adult would want measured.10
Will HGH remove belly fat?
human RCT
No trial among the research behind this page behind these approvals measured body fat as an outcome, and that is the first thing worth saying plainly. What was measured points the other way. In HIV-associated wasting, a 2006 review reports that somatropin increased work output, bodyweight and lean body mass against placebo in those patients, and bodyweight going up was the point of the exercise.5 In children the endpoint was height, not shape: the heiGHt trial measured annualised height velocity at week 52 in patients with a hormone deficiency.7 So the honest position is that the body composition question has an answer running in the opposite direction to the one people arrive with, and the fat loss question has no answer at all. Weight gained back by a wasting patient and fat lost by a healthy adult are different questions, and only the first has been studied.
What are the signs that HGH is working?
human RCT
In the trials, working was not something anyone felt. It was something a clinic measured, in two ways. The first is growth itself. The primary end point was annualized height velocity (AHV) at week 52 in the heiGHt trial, and three years of jet-delivered growth hormone produced sustained year-on-year increments in HTSDS and significant improvement in target HTSDS positions (by 1.32 SDS) compared to baseline in the patients who kept to the schedule, HTSDS being a child's height scored against others of the same age.713 The second is a blood marker. In the enliGHten trial, mean values of weekly average IGF-1 remained within 0-2 SDS throughout the trial, IGF-1 being insulin-like growth factor 1, the hormone that rises in the blood when growth hormone acts.11 Both signs are tied to a diagnosis and a target range set for it. Outside those diagnoses, no published marker of a working response exists, so what a healthy adult would be looking for has not been defined rather than being obvious. The measured outcomes, and the people they were measured in, are set out at the HGH results page.
How is HGH injected?
human RCT
Under the skin, and until recently every day. A 2021 trial report opens on that burden, noting that treatment burden with daily somatropin injections [human growth hormone (hGH)] is high, which may lead to poor adherence and suboptimal overall treatment outcomes.7 The long-acting versions were built to answer it. Lonapegsomatropin is administered as a once-weekly subcutaneous injection, and its slow release eliminates the need for daily somatropin injections.2 Devices matter as much as the route. In a UK database of 4,093 children, persistence with GH therapy was significantly longer in patients using ZomaJet compared to needle-based devices (599 days versus 535 days).14 A ZomaJet is a needle-free injector that drives the dose through the skin under pressure. People stop anyway. In Japanese claims data, 19% of children had stopped by 12 months and 35% by 48 months on one database, and 33% and 54% on another.15 Amounts and schedules are set on the dosage page.
Which peptide is closest to HGH?
review
The closest things to growth hormone are engineered versions of growth hormone, and there are four kinds in the published record. One is the long-acting prodrug. A reference entry describes lonapegsomatropin as a long-acting prodrug of somatropin, with polyethylene glycol as the carrier that slows it down.16 Another is a modified protein: somatrogon and somapacitan are both described against the closely related recombinant human growth hormone, somatropin, rather than as separate molecules.17 A third is somatrem, an older recombinant form held against the same comparison.18 The fourth is the approved copy. Biosimilars of recombinant somatropin have gained market authorisation in the EU, which means a regulator has compared them with the original and accepted them.3 Compounds sold as growth-hormone releasing peptides work by a different route and are covered on the comparison page. They are not versions of this hormone, and nothing on this page describes them.
Is HGH a prescription medicine?
review
In the United States it is, and the enforcement record says so in the plainest possible way. FDA recall listings describe Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, and another entry for a 5 mg vial of Tev-Tropin carries the words Prescription Only.1920 A third, covering a needle-free device sold with Zomacton, is also marked Rx only.21 Those three letters carry the whole regulatory position. Approval attaches to a particular injection, made by a named firm to a filed specification, and dispensed against a prescription written for a diagnosis. Europe works the same way through a different door: a regulator there has approved copies rather than new uses, and biosimilars of recombinant somatropin have gained market authorisation in the EU.3 What none of that establishes is the legal position of material bought outside a pharmacy. The safety page sets out what the enforcement record does and does not cover. What a buyer can actually check on a seller, a label and a certificate is set out at the HGH sourcing page.
What is documented about side effects?
human RCT
One paragraph, because the detail has its own page. The largest record is the KIGS registry of 83,803 children, in which SAEs occurred in 3.7% of patients and death in 0.4%, and the most common SAEs were recurrence of craniopharyngioma (n = 151), neoplasm (n = 99), and cancer (n = 91); and scoliosis (n = 91), craniopharyngioma being a brain tumour some of these children were already managed for.10 In the controlled trials the ordinary rate was far higher and far milder, with a similar percentage of subjects experiencing mild to moderate treatment-emergent adverse events in both groups (somatrogon: 78.9%, somatropin: 79.1%).8 Supply has its own record: one Class II recall was filed because TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.22 Who was excluded, what happens to blood sugar, and what the whole recall list holds are set out on the safety page.
How does HGH work?
human pilot / early trial
Growth hormone acts mostly by making something else, and the trials track that something else rather than the hormone itself. In the enliGHten trial the measurement watched over six years was IGF-1, and mean values of weekly average IGF-1 remained within 0-2 SDS throughout the trial, insulin-like growth factor 1 being the signal the liver releases in response.11 Where it acts depends on the tissue. In the gut, a 2004 review says somatropin is thought to enhance intestinal adaptation in this condition through direct or indirect effects on the intestine, adaptation meaning the remaining bowel learning to absorb more.1 In wasting the target was body composition, where a review reports that somatropin increased lean body mass and bodyweight against placebo in patients with HIV-associated wasting.5 Three tissues, three outcomes, one hormone, and in each case the effect was measured inside a condition rather than in a body that was working normally.
Regulatory status
Approved by the FDA as a prescription injection for growth failure from inadequate growth hormone secretion, for short bowel syndrome and for HIV-associated wasting · biosimilars of recombinant somatropin authorised in the EU · no approval covers ageing, muscle or athletic performance in a healthy adult · eight FDA recalls on the public record
What we don’t know
The gaps in the evidence matter as much as the findings.
- 01What growth hormone does in a healthy adult. Every participant in the published record carried a diagnosis, so the effect in someone with normal secretion is unmeasured rather than settled.
- 02Whether any of it changes body fat. No trial behind these approvals measured body-fat change as an outcome, in any population.
- 03What amounts above a replacement range do. Doses in these trials were set against a diagnosis and kept inside a target blood range, and nothing among the research behind this page administered more.
- 04What is inside a vial that did not come from a pharmacy. No analysis among the research behind this page has measured the identity, concentration or sterility of material sold outside the approved supply.
- 05What happens past six years. The longest published follow-up is the enliGHten extension, and nothing among the research behind this page runs longer.
- 06Whether the registry's cancer counts mean anything causal. They were counted in treated children with no untreated comparison group alongside them.
- 07What a working response would look like outside a diagnosis. The published markers are height velocity in children and a blood IGF-1 range, and neither applies to an adult without a deficiency.
Sources
- 1Somatropin (Zorbtive): in short bowel syndrome Drugs 2004. doi:10.2165/00003495-200464120-00008review
- 2Lonapegsomatropin: Pediatric First Approval Paediatr Drugs 2022. doi:10.1007/s40272-021-00478-8review
- 3[Biosimilars] Ther Umsch 2011. doi:10.1024/0040-5930/a000227review
- 4Intestinal adaptation following resection JPEN J Parenter Enteral Nutr 2014. doi:10.1177/0148607114525210review
- 5Mammalian cell-derived somatropin : a review of its use in the management of HIV-associated wasting Drugs 2006. doi:10.2165/00003495-200666030-00014review
- 6Spotlight on mammalian cell-derived somatropin in HIV-associated wasting BioDrugs 2006. doi:10.2165/00063030-200620030-00006review
- 7Weekly Lonapegsomatropin in Treatment-Naïve Children With Growth Hormone Deficiency: The Phase 3 heiGHt Trial J Clin Endocrinol Metab 2021. doi:10.1210/clinem/dgab529human RCT
- 8Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Phase 3 Study J Clin Endocrinol Metab 2022. doi:10.1210/clinem/dgac220human RCT
- 9Efficacy and Safety of Once-Weekly Somatrogon Compared with Once-Daily Somatropin (Genotropin®) in Japanese Children with Pediatric Growth Hormone Deficiency: Results from a Randomized Phase 3 Study Horm Res Paediatr 2022. doi:10.1159/000524600human RCT
- 10Safety and Efficacy of Pediatric Growth Hormone Therapy: Results From the Full KIGS Cohort J Clin Endocrinol Metab 2022. doi:10.1210/clinem/dgac517human pilot / early trial
- 11Children with Growth Hormone Deficiency Treated with Lonapegsomatropin Demonstrated Sustained Height Improvements for up to 6 Years: enliGHten Trial Final Results Horm Res Paediatr 2026. doi:10.1159/000545064human pilot / early trial
- 12Comparative Outcomes of GH Treatment in Pediatric Idiopathic Short Stature and GH Deficiency J Endocr Soc 2025. doi:10.1210/jendso/bvaf133primary research
- 13Improved adherence and growth outcomes with jet-delivered growth hormone J Pediatr Endocrinol Metab 2019. doi:10.1515/jpem-2018-0067human pilot / early trial
- 14Maintaining persistence and adherence with subcutaneous growth-hormone therapy in children: comparing jet-delivery and needle-based devices Patient Prefer Adherence 2014. doi:10.2147/PPA.S70019human pilot / early trial
- 15Persistence with daily growth hormone among children and adolescents with growth hormone deficiency in Japan PLoS One 2025. doi:10.1371/journal.pone.0324728primary research
- 16Lonapegsomatropin 2006. PMID 34554672review
- 17Somatrogon 2006. PMID 40864839review
- 18Somatrem 2006. PMID 30000557review
- 19Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21 2016. sourceregulatory action
- 20TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960 2013. sourceregulatory action
- 21ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free H 2021. sourceregulatory action
- 22TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 2014. sourceregulatory action
