Updated August 2026
Sermorelin Dosage: Historical FDA Dosing, Human Studies, and Research Protocols
Research and regulatory notice: There is no currently marketed FDA-approved Sermorelin product or current FDA-approved adult “anti-aging,” weight-loss, muscle-building, sleep, or wellness dosage. Geref products were historically FDA approved for diagnostic testing and pediatric growth failure, then discontinued. Current compounded preparations are not FDA approved. The doses below document historical labeling, published research, and anecdotal protocols — not individualized treatment instructions.
The historical pediatric Geref label recommended 0.03 mg/kg (30 mcg/kg) SC once daily at bedtime for prepubertal children with idiopathic GH deficiency and growth failure. Diagnostic use was a single 1 mcg/kg IV challenge.
Acute human research found measurable GH release from 0.25 mcg/kg IV, with maximal response around 1–2 mcg/kg IV. Adult experiments often used 0.5–2 mg per administration — much larger than current online 100–500 mcg bedtime schedules.
Sermorelin is short acting (~11–12 minute half-life after IV/SC in historical product information; ~6% absolute SC bioavailability in a small PK study). Doubling pediatric GHRH from 30 to 60 mcg/kg/day did not improve six-month growth velocity versus the lower dose, while recombinant GH produced greater growth.
Sermorelin dosage in 30 seconds
| Question | Evidence-based answer |
|---|---|
| Current FDA-approved product / adult wellness dose? | No — historical Geref discontinued; compounded ≠ approved |
| Historical pediatric treatment | 30 mcg/kg SC once daily at bedtime |
| Historical diagnostic dose | 1 mcg/kg IV single challenge |
| Acute IV max response (research) | Around 1–2 mcg/kg; significant from 0.25 mcg/kg |
| Key adult experimental doses | 0.5–1 mg BID; 2 mg nightly; 1 mg q12h (HIV lipodystrophy) |
| Common online adult range | 100–500 mcg SC bedtime (anecdotal) |
| Reported half-life | ~11–12 minutes (IV or SC) |
| 30 vs 60 mcg/kg/day growth | Doubling did not clearly help |
What is Sermorelin?
Sermorelin acetate is the acetate salt of amidated synthetic GHRH(1–29)-NH2 — the biologically active amino-terminal portion of native 44-aa GHRH. It binds the GHRH receptor on pituitary somatotrophs to stimulate synthesis and pulsatile release of endogenous GH (which can raise IGF-1). It is not recombinant human GH.
Dosing consequences: acute response varies with pituitary reserve, age, body composition, and somatostatin tone; a larger dose does not guarantee proportionally more GH; diagnostic IV, pediatric growth, and adult experimental dosing answer different questions. Do not transfer results from CJC-1295 or tesamorelin to Sermorelin.
FDA status: historically approved, not currently marketed
Sermorelin is unusual among online peptides because specific Geref products did have FDA approvals. FDA later determined the products were not withdrawn for reasons of safety or effectiveness — that does not mean an approved Geref product is currently marketed, and it does not make today's compounded Sermorelin FDA approved.
Accurate: specific Geref products were historically approved for narrow diagnostic and pediatric uses. Inaccurate: “never FDA approved” or “clinic Sermorelin today is FDA approved.”
Historical FDA products
Geref was approved — today's compounded Sermorelin is not
Geref Diagnostic (NDA 19-863)
0.05 mg base per ampule
- Purpose
- Provocative testing of pituitary GH secretion
- Historical dose
- 1 mcg/kg IV single challenge
- Status
- Approved 1990; later discontinued
Geref (NDA 20-443)
0.5 mg and 1 mg base per vial
- Purpose
- Idiopathic GH deficiency in prepubertal children with growth failure
- Historical dose
- 0.03 mg/kg (30 mcg/kg) SC once daily at bedtime
- Status
- Approved 1997; later discontinued
Withdrawal not for safety/effectiveness ≠ current marketed approval ≠ compounded adult wellness approval.
Historical FDA-approved dosage
Pediatric treatment: 0.03 mg/kg (30 mcg/kg) SC once daily at bedtime. At 30 mcg/kg, a 20 kg child receives 600 mcg and a 30 kg child 900 mcg — this regimen cannot be repackaged as a modern adult “microdosing” protocol.
Diagnostic use: 1 mcg/kg IV once with serial GH measurements — ~30× smaller on a weight basis than the daily pediatric treatment dose, and a different route. Confusing these applications is a category error.
Historical labeled uses
| Use | Dose | Route | Frequency | Purpose |
|---|---|---|---|---|
| Pediatric treatment | 30 mcg/kg | SC | Once daily bedtime | Idiopathic GHD + growth failure |
| Diagnostic challenge | 1 mcg/kg | IV | Single supervised dose | Evaluate pituitary GH reserve |
Dosage used in human clinical trials
Keep historical FDA, adult experimental, and anecdotal adult schedules in separate evidence lanes.
Evidence lanes
Historical FDA · Adult experimental · Anecdotal clinic
Geref Diagnostic and Geref treatment had narrow labeled uses. FDA later determined withdrawal was not for safety or effectiveness. That does not make today's compounded adult products FDA approved.
| Setting | Dose | Finding |
|---|---|---|
| Diagnostic challenge | 1 mcg/kg IV once | Assess pituitary GH reserve — not a treatment regimen |
| Pediatric Geref label | 30 mcg/kg SC nightly | Idiopathic GHD + growth failure; specialist monitoring |
| 110-child once-daily study | 30 mcg/kg SC bedtime ≤12 mo | Height velocity ↑ ~4.1 → 8.0 (6 mo) / 7.2 cm/yr (12 mo) |
| 30 vs 60 mcg/kg/day RCTs | Divided or continuous SC | Doubling dose did not clearly improve growth; GH comparator stronger |
Acute dose-response and route differences
- IV response begins below the diagnostic dose. Significant GH from 0.25 mcg/kg IV; average maximum around 1–2 mcg/kg IV — saturable acute response, not an optimal repeated SC dose.
- Intranasal delivery required far more peptide. Bioavailability ~3%–5%; ~50 mcg/kg IN ≈ 1 mcg/kg IV PD response. Pediatric IN pilot: attenuated response, antibodies, local symptoms, no 6-month height-velocity gain.
- Subcutaneous PK are short. After 2 mg SC: peak ~5–20 min; absolute bioavailability ~6%; elimination half-life ~11–12 min IV or SC. GH can remain elevated longer than measurable peptide.
Claim checker
Common Sermorelin dosing myths vs evidence
The pediatric label was 0.03 mg/kg (30 mcg/kg) — weight-based, not a universal 0.2–0.3 mg adult amount.
Pediatric dose-response: more was not clearly better
Two randomized pediatric studies compared 30 and 60 mcg/kg/day. In a continuous-infusion comparison, six-month mean height velocities were essentially identical at 30 vs 60 mcg/kg/day (~9.2 vs 9.3 cm/year) while recombinant GH reached ~14.6 cm/year. Doubling Sermorelin exposure produced essentially no additional growth velocity in that experiment.
Pediatric continuous-infusion comparison
30 vs 60 mcg/kg/day — doubling did not add growth velocity
Six-month mean height velocity. Argues against assuming a linear dose–benefit relationship for Sermorelin/GHRH(1–29).
Once-daily pediatric treatment evidence
The largest treatment study enrolled 110 previously untreated prepubertal children with idiopathic GHD using 30 mcg/kg SC once daily at bedtime for up to one year. Among 86 efficacy-evaluable children, mean height velocity rose from ~4.1 to 8.0 cm/year at six months and 7.2 at 12 months (~74% good responders at six months).
Open label; 24/110 excluded from efficacy analysis; final adult height not established; labeling advised reconsidering treatment when growth was poor or waning.
Adult research dosage
0.5 or 1 mg SC BID × 14 days in older men increased GH/IGF-1 toward younger levels — too short for durable clinical-benefit claims.
2 mg SC nightly × 6 weeks increased nocturnal GH measures but not IGF-1 or body composition — important because marketing often claims nightly Sermorelin reliably raises IGF-1 despite using much smaller clinic doses.
1 mg SC every 12 hours × 12 weeks in an HIV-lipodystrophy RCT improved IGF-1, lean mass, and trunk-fat measures — stronger adult outcome evidence, but disease-specific, not an anti-aging regimen for healthy adults.
Dose-by-body-weight examples
Mathematical study-reference tool only — not a dosing recommendation. Do not extend the historical 30 mcg/kg pediatric rule to adults.
Published-study math only. No currently marketed FDA-approved adult dosage. Historical 30 mcg/kg is not an adult weight-based recommendation.
Published-study math
Historical / research weight-based exposures — not adult recommendations
Not a recommended dose calculator. Do not apply 30 mcg/kg as an adult wellness schedule.
Study exposure
- Research context
- Historical pediatric Geref treatment dose
- Total for 30 kg
- 900 mcg
Sermorelin research dosage: commonly reported protocols
Human studies support acute dose-dependent GH release, short half-life, GH (± sometimes IGF-1) rises with repeated administration, pediatric growth at 30 mcg/kg/day in some children, and disease-specific body-composition changes at 1 mg BID in HIV lipodystrophy.
Evidence does not establish that 200–300 mcg is optimal for adults, that five nights/week is better than nightly, that 100 mcg is a universal start, that 500 mcg is a maximum, that fixed cycles are required, or that current clinic doses improve body composition, recovery, energy, or longevity in healthy adults.
Reported adult research / clinic landscape
| Summary | |
|---|---|
| Reported online range | ≈100–500 mcg fixed adult administration; experiments also used 0.5–2 mg |
| Most common online | 200–300 mcg |
| Frequency | Usually nightly; some 5 nights/week |
| Route | Subcutaneous |
| Typical duration | Often 8–12 weeks or 3–6 months |
| Evidence quality | Moderate historical pediatric/acute; low for fixed adult wellness schedules |
Where the modern fixed-dose protocol appears to come from
The original source could not be reliably traced. Contemporary pages often repeat 0.2–0.3 mg nightly as if from historical labeling — the actual Geref pediatric label used 0.03 mg/kg, not a universal fixed adult amount. Likely influences: simplifying weight-based pediatric dosing, preference for lower adult exposures than older studies, vial convenience, clinic-page repetition, and unproven nocturnal-pulse synchronization ideas.
Research protocol variations
- Nightly vs five nights/week. Pediatric label and 110-child study used daily bedtime dosing. No controlled trial showed weekends-off is superior or safer.
- Bedtime timing. Genuine research/labeling history (pediatric + 6-week older-adult study) — more evidence-linked than many peptide timing claims. Comparative superiority vs morning/daytime remains limited.
- Once daily vs divided. Both studied in different populations; too heterogeneous to declare one frequency universally superior.
- Combination with Ipamorelin/GHS. Mechanistic synergy ≠ established safety, efficacy, ratio, or frequency for wellness protocols.
- Continuous vs cyclical. Pediatric studies used continuous daily treatment for months. No controlled study established a required 8- or 12-week adult cycle.
Animal and preclinical research dosage
Animal exposures must remain separate from human dosing. Example: in young rats, 0.5 mg/kg SC daily increased high-affinity pituitary GHRH-receptor binding, while 1 mg/kg reduced those sites and decreased circulating IGF-1 and growth rate — higher is not automatically better.
Dosage evidence ladder
Sermorelin dosing is well documented for historical diagnostic and pediatric indications, but those discontinued uses do not create a current approved adult regimen. Modern fixed adult doses are substantially less established.
Dosage evidence ladder
How established is Sermorelin dosing?
- 1
Historical FDA-approved pediatric dosing
strong historical30 mcg/kg SC nightly — product discontinued
- 2
Historical diagnostic dosing
strong historicalSingle 1 mcg/kg IV challenge — no longer marketed US test
- 3
Pediatric clinical-trial dosing
moderateSeveral trials at 20–60 mcg/kg/day including randomized comparisons
- 4
Adult experimental dosing
low moderateSmall studies at 0.5–2 mg; one disease-specific RCT
- 5
Preclinical dosing
mechanismNot a human protocol
- 6
Anecdotal adult protocols
low100–500 mcg fixed schedules lack controlled dose optimization
- 7
Long-term adult dosing
poorNo robust long-term trial for healthy-adult wellness outcomes
Dose escalation
No validated week-by-week Sermorelin titration schedule was identified for current adult wellness use. Formal research compared doses as controlled experiments (acute IV ranges; pediatric 30 vs 60; older-men 0.5 vs 1 mg BID) — not lifestyle titration. Clinic pages describing 100–200 → 300–500 mcg based on symptoms/IGF-1 have no controlled trial validation.
Safety and tolerability
Historical Geref experience reported injection-site reactions in ~1/6, hypothyroidism in 6.5% of clinical-study participants, and anti-GRF antibodies in a large pediatric proportion. Compounded Sermorelin is not a generic equivalent automatically proven to match Geref — potency, sterility, and beyond-use dating are pharmacy-specific.
Safety findings
Historical Geref experience ≠ compounded adult safety proof
| Topic | Finding | Note |
|---|---|---|
| Injection-site reactions | ~1 in 6 (historical) | Pain, swelling, or redness |
| Hypothyroidism in studies | 6.5% | Label advised thyroid monitoring |
| Anti-GRF antibodies | Large pediatric proportion | Uncertain clinical importance |
| Current compounded long-term adult safety | Not established | Not equivalent to historical Geref |
Sporting status
Sermorelin is a growth hormone-releasing factor prohibited under WADA's GHRF/secretagogue category. Prescription, compounded status, or “research” labeling does not make use permissible for tested athletes.
Sourcing and origin checks
- Is the source describing Geref Diagnostic, pediatric Geref, an adult experiment, or a compounded clinic protocol?
- Is the dose fixed or weight based? Route IV, SC, IN, or continuous infusion?
- Is “GHRH(1–29)” exact Sermorelin or a modified analogue?
- Does a current fixed adult amount trace to a primary study — or misquote 0.03 mg/kg as 0.2–0.3 mg?
- Is tesamorelin/CJC-1295 efficacy being imported incorrectly?
Bottom line
Modern pages often blur four dose categories: historical diagnostic (1 mcg/kg IV once), historical pediatric treatment (30 mcg/kg SC nightly), published adult experiments (0.5–2 mg in small specialized cohorts), and current compounded clinic schedules (100–500 mcg).
Present historical approval accurately without converting it into implied approval of today's compounded adult use. No controlled program has established an optimal fixed adult dose, five-on/two-off schedule, cycle length, combination ratio, or wellness outcome.
Frequently asked questions
What is the standard Sermorelin dosage?
There is no currently marketed FDA-approved standard. Historical pediatric Geref dosing was 30 mcg/kg SC once daily at bedtime. Current adult clinic protocols commonly report 100–500 mcg nightly, but no controlled dose-ranging trial established that range as optimal.
Was Sermorelin FDA approved?
Yes, specific Geref products were historically approved for diagnostic testing and treatment of idiopathic GH deficiency in children with growth failure. They were discontinued. Current compounded Sermorelin is not FDA approved.
What dose was used for the Sermorelin stimulation test?
The commonly studied historical challenge was a single 1 mcg/kg IV dose with serial GH measurements. It was a diagnostic procedure, not a repeated treatment regimen.
What dose was studied in children?
The principal once-daily study and historical label used 30 mcg/kg SC at bedtime. Other studies examined 20 mcg/kg twice daily, 30–60 mcg/kg/day in divided doses or continuous infusion, and 50 mcg/kg intranasally three times daily.
What dose was studied in adults?
Published adult studies used 0.5 or 1 mg SC twice daily for 14 days, 2 mg SC nightly for six weeks, and 1 mg SC every 12 hours for 12 weeks in men with HIV-associated lipodystrophy.
Is 200–300 mcg an FDA-approved adult dose?
No. That fixed range is widely repeated in modern clinic and community material, but the historical FDA pediatric label was weight based and there was no approved anti-aging or wellness indication.
Should Sermorelin be used every night or five nights per week?
Nightly dosing has historical study and labeling support for pediatric treatment. No controlled trial was identified that showed five nights per week is superior or safer than nightly use.
Does Sermorelin have to be taken at bedtime?
Bedtime was used in historical pediatric treatment and an older-adult study, providing a legitimate research precedent. Direct evidence that bedtime produces better clinical outcomes than other timings remains limited.
What is Sermorelin's half-life?
Historical product information reported approximately 11–12 minutes after IV or SC administration. The GH response can last longer than circulating peptide exposure.
Does Sermorelin increase IGF-1?
It can, but not consistently. Twice-daily studies in older men and men with HIV lipodystrophy increased IGF-1, while 2 mg nightly for six weeks in 11 healthy older men did not significantly change IGF-1.
Does Sermorelin improve muscle or reduce fat?
A disease-specific RCT in men with HIV lipodystrophy reported increased lean mass and improved trunk-fat measures at 1 mg twice daily. A six-week study in healthy older men found no body-composition change. Evidence does not establish routine efficacy in healthy adults at current clinic doses.
Is Sermorelin the same as CJC-1295 without DAC?
No. Both relate to GHRH(1–29), but modified GRF/CJC-1295 without DAC has amino-acid substitutions. Pharmacokinetics and study evidence should not be treated as interchangeable.
Is Sermorelin the same as tesamorelin?
No. Tesamorelin is a stabilized GHRH analogue with its own current FDA-approved product, indication, pharmacokinetics, and dosing.
Is Sermorelin permitted in tested sport?
No. It belongs to the prohibited growth hormone-releasing factor category under WADA rules.
Primary references
FDA
Determination that Geref presentations were not withdrawn for reasons of safety or effectivenessFederal Register, 2013.
Thorner MO et al.
Once-daily subcutaneous GHRH(1–29) therapy in GH-deficient childrenJCEM, 1996.
Corpas E et al.
GHRH(1–29) twice daily in healthy older menJCEM, 1992.
Vittone J et al.
Single nightly GHRH(1–29) injections in healthy elderly menMetabolism, 1997.
Koutkia P et al.
GHRH in HIV-infected men with lipodystrophy: randomized controlled trialJAMA, 2004.
Wilton P et al.
Pharmacokinetics and GH response after IV or intranasal GHRH(1–29)-NH2Acta Paediatrica Supplement, 1993.
Neyzi O et al.
Growth response to 30 versus 60 mcg/kg/day GHRH(1–29)-NH2 compared with GH1993.
WADA
2026 Prohibited ListGHRH / releasing factors prohibited at all times.
Important Safety Information
There is no currently marketed FDA-approved Sermorelin product and no FDA-approved adult wellness dosage. Historical Geref products were discontinued. Current compounded preparations are not FDA approved.
This page documents historical labeling, published research, and commonly reported protocols. It is not a dosing, reconstitution, cycle, or self-administration guide.
Do not convert the historical 30 mcg/kg pediatric dose into an adult weight-based recommendation, and do not import dosing from tesamorelin or CJC-1295.