Updated August 2026
Ipamorelin Dosage: Human Trials, Research Protocols, and Evidence
Research status: Ipamorelin is not an FDA-approved drug and has no FDA-approved dosage. This page documents published research and commonly reported experimental protocols; it is not a dosing recommendation or a guide to self-administration.
No approved dose exists. Ipamorelin has no FDA-approved indication, product label, starting dose, maintenance dose, or maximum dose.
Human research used intravenous, weight-based dosing. A PK/PD study tested single 15-minute IV infusions of approximately 3–100 mcg/kg. A published Phase 2 study used 0.03 mg/kg IV twice daily for up to seven days. A later Phase 2 dose-finding study registered higher IV arms (0.03 mg/kg BID, 0.06 mg/kg BID, 0.06 mg/kg TID); results were not posted.
Online protocols are different. Fixed subcutaneous doses of roughly 100–300 mcg per administration are frequently repeated, usually once daily or up to three times daily. These schedules have not been validated in controlled human trials. FDA reported that it found no PK/PD or safety data for the commonly proposed subcutaneous route.
Ipamorelin dosage in 30 seconds
| Question | Evidence-based answer |
|---|---|
| Is there an FDA-approved ipamorelin dosage? | No |
| Most clearly documented human trial dose | 0.03 mg/kg IV twice daily for up to 7 days |
| Other registered human trial arms | 0.03 mg/kg IV BID; 0.06 mg/kg IV BID; 0.06 mg/kg IV TID |
| Published human PK dose range | 4.21–140.45 nmol/kg IV over 15 minutes (~3–100 mcg/kg) |
| Commonly reported online range | 100–300 mcg per subcutaneous administration, usually 1–3× daily |
| Is the online range clinically established? | No |
| Is subcutaneous PK established in humans? | FDA reported that it did not identify it |
| Is a dose-by-weight chart established for SC use? | No |
Is there an FDA-approved ipamorelin dosage?
No. Ipamorelin is an investigational growth-hormone secretagogue with no FDA-approved product or labeled indication. It therefore has no approved starting dose, titration schedule, maintenance dose, or maximum dose.
FDA's compounding safety page lists ipamorelin acetate as a substance that may present significant safety risks for compounding. The agency cites possible immunogenicity from aggregation or peptide-related impurities, difficulties characterizing a peptide with unnatural amino acids, serious events in an IV clinical study, and a lack of safety information for other injectable routes. The 503A nomination is listed as withdrawn; ipamorelin acetate appears under 503B Category 2 safety policy. Regulatory listing is not approval.
There is currently no FDA-approved dosage for ipamorelin. The doses below describe doses evaluated in human research rather than an established prescribing protocol.
Dosages used in human clinical trials
Three human programs define the formal dosage landscape: a healthy-volunteer PK/PD study, a published Phase 2 postoperative-ileus trial, and a later registered Phase 2 dose-finding study without posted results.
Evidence-tier dosage switcher
Human clinical · Anecdotal · Animal — keep the label visible
Weight-based intravenous infusions in healthy men (PK/PD) and postoperative adults (Phase 2). Short duration; GI recovery endpoints — not body composition.
| Protocol / study | Dose | Frequency | Route | Duration | Finding |
|---|---|---|---|---|---|
| Gobburu et al., 1999 | 4.21–140.45 nmol/kg (~3–100 mcg/kg) | Single dose | 15-minute IV infusion | One administration | Dose-proportional PK; t½ ~2 h; GH peaked ~0.67 h |
| Beck et al., 2014 / NCT00672074 | 0.03 mg/kg | Twice daily | IV infusion | POD 1 through day 7 or discharge | Primary efficacy not significant vs placebo (p=0.15) |
| NCT01280344 | 0.03 mg/kg BID; 0.06 mg/kg BID; 0.06 mg/kg TID | BID or TID | IV infusion | Outcomes up to 10 days | Completed; results not posted / no peer-reviewed report identified |
Human clinical dosage summary
| Study | Dose | Frequency | Route | Duration | Main finding |
|---|---|---|---|---|---|
| Gobburu 1999 | 4.21–140.45 nmol/kg | Single | 15-min IV | One dose | Dose-proportional PK; GH peak ~0.67 h; t½ ~2 h |
| Beck 2014 / NCT00672074 | 0.03 mg/kg | BID | IV | Up to 7 days | Efficacy endpoints not significant vs placebo |
| NCT01280344 | 0.03 BID; 0.06 BID; 0.06 TID (mg/kg) | BID or TID | IV | Up to 10 days | Completed; results not posted |
Human PK/PD dose-escalation study
The earliest controlled human study characterized pharmacokinetics and growth-hormone release—not a treatment dose. Participants were assigned to parallel dose groups; the study did not describe a within-person titration schedule.
Reported IV dose groups (Gobburu 1999)
| Reported dose | Approx. mass-equivalent* | Administration | What was measured |
|---|---|---|---|
| 4.21 nmol/kg | 3 mcg/kg | 15-minute IV infusion | Ipamorelin and GH |
| 14.02 nmol/kg | 10 mcg/kg | 15-minute IV infusion | Ipamorelin and GH |
| 42.13 nmol/kg | 30 mcg/kg | 15-minute IV infusion | Ipamorelin and GH |
| 84.27 nmol/kg | 60 mcg/kg | 15-minute IV infusion | Ipamorelin and GH |
| 140.45 nmol/kg | 100 mcg/kg | 15-minute IV infusion | Ipamorelin and GH |
*Approximate conversions use free-base molecular weight to make published units easier to compare. The original paper reported nmol/kg. These are not converted treatment recommendations.
Ipamorelin displayed dose-proportional pharmacokinetics. Terminal half-life was about two hours, while the GH response was pulse-like: GH peaked around 40 minutes and declined to negligible levels at every tested dose. The lowest dose and placebo groups produced negligible GH and were excluded from the PK/PD modeling.
Phase 2 postoperative-ileus dose
In the published Phase 2 trial, participants received 0.03 mg/kg by IV infusion twice daily, beginning on postoperative day 1 and continuing until day 7 or hospital discharge. The dose was studied for short-term recovery of gastrointestinal function after bowel resection—not for muscle gain, fat loss, recovery, sleep, anti-aging, or growth-hormone deficiency.
Median time to tolerate a standardized solid meal was 25.3 hours with ipamorelin and 32.6 hours with placebo; the difference was not statistically significant (p=0.15). No significant difference was found in key or secondary efficacy analyses.
Clinical exposure comparison
Historical IV trial exposure by body weight — not a recommended dose
Every output is a historical trial exposure for the selected IV arm. Do not convert these figures into syringe units or a subcutaneous protocol.
Trial arm
- Selected arm
- Beck 2014 · 0.03 mg/kg BID
- Published Phase 2 postoperative ileus regimen
- Per-infusion exposure
- 2,100 mcg (2.10 mg)
- 0.03 mg/kg × 70 kg
- Nominal daily exposure
- 4,200 mcg (4.20 mg)
- 2× daily IV infusion
Historical trial exposure — not a recommended dose
Phase 2 dose-finding arms
NCT01280344 registered three active IV regimens. These are protocol exposures, not recommended doses. The study completed with 320 participants, but the registry does not provide results—so dose-response, comparative efficacy, and arm-specific adverse-event rates cannot be reliably stated.
Registered NCT01280344 arms
| Trial arm | Per-infusion dose | Daily frequency | Nominal daily exposure |
|---|---|---|---|
| Lower-dose arm | 0.03 mg/kg | Twice daily | 0.06 mg/kg/day |
| Higher-dose BID arm | 0.06 mg/kg | Twice daily | 0.12 mg/kg/day |
| Higher-dose TID arm | 0.06 mg/kg | Three times daily | 0.18 mg/kg/day |
Ipamorelin research dosage
People searching for an “ipamorelin research dose” usually encounter fixed-dose subcutaneous protocols that look very different from the published human studies. Those protocols are worth documenting because they are widespread, but their evidentiary status must remain unmistakable.
Human research supports one narrow conclusion: IV ipamorelin produces a measurable, dose-related GH response, and short courses of weight-based IV dosing have been tested after bowel surgery. It does not establish that 100–300 mcg subcutaneously produces a particular clinical outcome, that bedtime administration is superior, that fasting improves effect, or that an 8–16-week cycle is safe.
FDA's 2024 scientific review reported that it did not identify human PK/PD information for subcutaneous ipamorelin or safety data for the proposed subcutaneous route. The route used in most online protocols is a materially different exposure with unresolved bioavailability, dose-response, and safety.
Route-and-duration contrast
Clinical IV short courses vs anecdotal subcutaneous cycles
Clinical research
- Route
- Intravenous infusion
- Duration
- 1 administration to ~7–10 postoperative days
- Dose style
- Weight-based (mg/kg or nmol/kg)
- Purpose
- PK/PD, GH release, postoperative GI recovery
Anecdotal protocols
- Route
- Subcutaneous injection
- Duration
- Usually 8–16 weeks (± breaks)
- Dose style
- Fixed mcg amounts (often 100–300 mcg)
- Purpose
- Sleep, recovery, body composition, “anti-aging” claims
Different route + duration = different exposure. Fixed SC mcg amounts are not scaled-down versions of weight-based IV trial doses.
Reported research dosage landscape
| Reported information | |
|---|---|
| Reported research range | 100–300 mcg per SC administration most often repeated; some sources describe higher amounts |
| Most commonly repeated amount | Approximately 200–300 mcg per administration |
| Frequency | Once daily is common; two or three daily administrations also appear |
| Route | Subcutaneous |
| Typical reported duration | 8–16 weeks, sometimes followed by a 4–8-week break |
| Human-trial overlap | Poor — trials used weight-based IV infusion, not fixed-dose SC injection |
| Evidence quality | Low to insufficient for efficacy and safety; largely clinic/vendor/community convention |
Anecdotal vs clinically studied dosing
Clinical research vs anecdotal reports
| Variable | Clinical research | Anecdotal research reports |
|---|---|---|
| Dose | 3–100 mcg/kg single IV (PK); 0.03–0.06 mg/kg per infusion (Phase 2) | Usually 100–300 mcg fixed per administration |
| Frequency | Single infusion (PK); BID or TID (Phase 2) | 1–3× daily; sometimes 5 on / 2 off |
| Route | IV infusion | Subcutaneous injection |
| Duration | Single dose or up to 7–10 postoperative days | Usually 8–16 weeks |
| Population | Healthy men or hospitalized adults after bowel surgery | Generally healthy or performance/longevity-focused adults online |
| Purpose | PK/PD, GH release, postoperative GI recovery | Sleep, recovery, body composition, “anti-aging,” GH optimization claims |
| Evidence | Controlled/published or registered clinical research | Uncontrolled reports and commercial protocols |
| Established safety | Limited to short IV exposure in narrow populations | Not established for chronic subcutaneous use |
A fixed 200 mcg subcutaneous dose cannot be treated as a scaled-down version of 0.03 mg/kg IV because route-dependent bioavailability has not been established. Absence of weight adjustment in online protocols is a convention—not evidence that body weight is irrelevant.
Research protocol variations
- Once-daily vs multiple daily dosing. Nighttime once-daily and multi-dose schedules often cite the ~2-hour half-life and brief GH pulse. Plausible—but no controlled human trial has compared once-daily with BID/TID subcutaneous dosing for marketed outcomes.
- Daily vs five-days-on/two-days-off. Off-days are claimed to reduce receptor desensitization. No published ipamorelin trial compared these schedules. Label five-on/two-off as an anecdotal convention.
- Monotherapy vs combination protocols. Combinations with CJC-1295 / Modified GRF 1-29 / sermorelin have a complementary-receptor rationale, but no controlled human trial has established optimal dose, ratio, timing, efficacy, or safety. “CJC-1295” may mean DAC CJC-1295 or “no DAC” (often Modified GRF 1-29)—not interchangeable exposures.
Animal / preclinical research dosage
Animal doses must not be presented as human research doses or casually converted into human protocols. Preclinical studies support biological activity in models; they do not establish a human dose for bone growth, recovery, body composition, pain, or gastrointestinal disease.
Selected preclinical exposures
| Model | Dose | Route | Duration | Outcome studied |
|---|---|---|---|---|
| Adult female rats | 18, 90, or 450 mcg/day (divided TID) | SC | 15 days | Bone growth, body weight, GH |
| Male rats (POI) | 0.01–1 mg/kg | IV bolus | Up to 2 days | Colonic transit, fecal output |
| Rats (POI) | 10 or 100 mg/kg | Oral gavage | Acute | Gastric emptying |
| Rats (POI) | 0.1, 0.25, or 1 mg/kg | IV | Acute | Gastric emptying |
| Visceral hypersensitivity | 0.01, 0.1, or 1 mg/kg | IV | Acute | Colonic hypersensitivity / allodynia |
Why these research doses and schedules appear
- Short pharmacokinetics and a brief GH response. Terminal half-life ~2 hours; GH peaked ~0.67 h and was negligible by six hours. This helps explain repeated dosing—it does not prove a particular chronic SC frequency is optimal.
- A dose-response signal—within the studied IV range. Dose-proportional PK and concentration-dependent GH stimulation were observed IV. That does not identify a subcutaneous “ceiling dose” or validate claims that benefits stop increasing above 300 mcg.
- Different experimental endpoints. Phase 2 doses targeted postoperative GI recovery. Animal studies used much higher per-kilogram exposures for motility, bone growth, or pain. Endpoint, species, route, and duration explain much of the apparent variation.
Dosage evidence ladder
Ipamorelin dosing is poorly established outside short-term intravenous research. Human studies show that IV exposure can stimulate GH and document several weight-based trial regimens, but they do not establish a chronic subcutaneous dose for recovery, sleep, body composition, or healthy aging. Fixed-dose protocols online should be treated as anecdotal conventions, not clinical dosing standards.
Dosage evidence ladder
How established is ipamorelin dosing?
- 1
FDA-approved dosing
None / insufficientNo approved ipamorelin product or indication
- 2
Human clinical-trial dosing
LimitedIV, short-term, narrow research populations
- 3
Published experimental dosing
MixedModerate for PK/GH response; weak for clinical benefit
- 4
Preclinical dosing
Preclinical onlyMultiple animal models — not transferable as human dosing
- 5
Anecdotal research protocols
Low / insufficientCommon online, but not validated; original source unclear
- 6
Long-term dosing evidence
None / insufficientNo controlled long-term subcutaneous regimen identified
Dose escalation
Formal clinical dose escalation. The 1999 PK/PD study used parallel dose groups rather than a therapeutic titration schedule. Participants did not move week by week through levels.
Anecdotally reported research escalation. Some online sources describe starting near 100 mcg once daily and increasing to 200–300 mcg after one or two weeks. No original controlled source was identified. “Syringe units” are not a dose—they describe liquid volume and change with vial strength/reconstitution. Protocols written only in units without mg/mL concentration and intended mcg mass are incomplete.
PK/PD parallel cohorts (not a titration protocol)
| Cohort | Dose | Stage | Trial context |
|---|---|---|---|
| 1 | 4.21 nmol/kg | Lowest | Single 15-min IV; negligible GH in model |
| 2 | 14.02 nmol/kg | Group 2 | Single 15-min IV infusion |
| 3 | 42.13 nmol/kg | Group 3 | Single 15-min IV infusion |
| 4 | 84.27 nmol/kg | Group 4 | Single 15-min IV infusion |
| 5 | 140.45 nmol/kg | Highest | Single 15-min IV infusion |
Safety findings relevant to dosage
The published 117-patient Phase 2 trial found similar overall treatment-emergent adverse-event rates with ipamorelin and placebo, but FDA's detailed review identified imbalances and unresolved concerns. Data came from medically complex postoperative patients and cannot be directly generalized to healthier users—or establish safety for chronic subcutaneous dosing.
FDA separately noted potential risks associated with raising GH/IGF-1—including glucose intolerance, fluid retention, intracranial hypertension, and neoplasm-related concerns known from approved recombinant GH labeling—while emphasizing that ipamorelin-specific evidence is insufficient.
Simple / full clinical safety toggle
NCT00672074 postoperative IV trial — surgery confounds many events
| Finding | Ipamorelin | Placebo |
|---|---|---|
| Hypokalemia | 12.5% | 3.4% |
| Insomnia | 10.7% | 5.2% |
| Hyperglycemia at discharge | 14.3% | 8.6% |
| Discontinuations for AE | 3 participants | — |
Postoperative population caveat: medically complex bowel-surgery patients. Long-term and subcutaneous safety are unknown. Two fatal SAEs occurred in ipamorelin-treated patients; causal relationship was unclear per FDA.
Editorial bottom line
The most defensible answer to “What is the ipamorelin dosage?” is not a single number. Ipamorelin has no approved dose; formal human evidence is limited to short-term, weight-based IV research; and the fixed-dose subcutaneous schedules most people encounter online remain unvalidated.
Show all three landscapes—clinical, preclinical, and anecdotal—without mistaking one for another.
Ipamorelin dosage FAQ
What is the standard ipamorelin dosage?
There is no standard or FDA-approved ipamorelin dosage. The most clearly published treatment-trial regimen was 0.03 mg/kg by IV infusion twice daily for up to seven days after bowel surgery. The 100–300 mcg subcutaneous range repeated online is anecdotal and should not be presented as a clinical standard.
What dose of ipamorelin was studied in humans?
Human research evaluated single 15-minute IV infusions of 4.21–140.45 nmol/kg, a published short-term regimen of 0.03 mg/kg IV twice daily, and registered Phase 2 arms of 0.03 mg/kg BID, 0.06 mg/kg BID, and 0.06 mg/kg TID.
Is ipamorelin dosage based on body weight?
The formal human trials used weight-based IV dosing. No evidence-backed weight-based chart was identified for chronic subcutaneous use. Online fixed-dose and weight-tier charts should be labeled anecdotal.
How often was ipamorelin used in clinical trials?
The PK/PD study used one IV infusion. The published Phase 2 trial used twice-daily IV infusions. A later registered Phase 2 trial included twice- and three-times-daily IV arms.
How long was ipamorelin used in clinical trials?
Published human exposure ranged from one administration to a maximum of seven postoperative days. NCT01280344 assessed outcomes for up to ten days. The 8–16-week cycles discussed online have not been validated by controlled human ipamorelin trials.
Is 200 mcg an established ipamorelin dose?
No. Two hundred micrograms is one of the most frequently repeated fixed amounts in online subcutaneous protocols, but no controlled human study was identified that established 200 mcg as effective, optimal, or safe for the uses commonly promoted.
Is 300 mcg the maximum ipamorelin dose?
No evidence establishes 300 mcg as a universal maximum. It is a common ceiling in anecdotal fixed-dose protocols. Human clinical studies used weight-based IV regimens that cannot be directly compared with a fixed subcutaneous amount.
Is bedtime the best time to use ipamorelin?
Bedtime timing is common in anecdotal protocols because natural GH secretion is pulsatile and includes a nocturnal peak. No controlled human ipamorelin trial was identified that compared bedtime with morning or other subcutaneous timing.
Does ipamorelin need to be used while fasting?
Fasted timing is frequently recommended online, but the pivotal human ipamorelin studies do not establish a specific pre- or post-meal fasting window for subcutaneous use. A rule such as “two hours after food” should be presented as a protocol convention, not proven dosing science.
Should ipamorelin be cycled five days on and two days off?
The five-on/two-off schedule is anecdotal. No controlled trial was identified that compared it with daily use or showed that it prevents receptor desensitization.
Has CJC-1295 plus ipamorelin dosing been studied in humans?
The combination is widely discussed, but no controlled human trial was identified that established an optimal combined dose, ratio, schedule, or long-term safety profile. Distinguish DAC CJC-1295 from the shorter-acting peptide commonly sold as “CJC-1295 no DAC.”
Can animal doses be converted into a human ipamorelin protocol?
Not reliably. Animal doses differ by species, endpoint, route, pharmacokinetics, and experimental design. A human-equivalent-dose calculation would be a mathematical estimate, not an established human protocol.
Primary and authoritative sources
FDA
Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksIpamorelin acetate compounding safety summary.
FDA PCAC
Scientific review of ipamorelin-related bulk drug substancesOctober 29, 2024.
Gobburu JVS et al.
Pharmacokinetic-pharmacodynamic modeling of ipamorelin in human volunteersPharmaceutical Research, 1999.
Beck DE et al.
Prospective randomized study of ipamorelin for postoperative ileusInternational Journal of Colorectal Disease, 2014.
ClinicalTrials.gov
NCT00672074Published Phase 2 postoperative ileus trial registry.
ClinicalTrials.gov
NCT01280344Phase 2 dose-finding; results not posted.
Johansen PB et al.
Ipamorelin and longitudinal bone growth in ratsGrowth Hormone & IGF Research, 1999.
Venkova K et al.
Ipamorelin in a rodent model of postoperative ileusJournal of Pharmacology and Experimental Therapeutics, 2009.
NCI
Ipamorelin — NCI Drug DictionaryMechanism definition.
Important Safety Information
Ipamorelin is investigational and not FDA approved. There is no approved dosage and no validated subcutaneous human PK/PD dataset identified by FDA.
This page documents published research and commonly reported experimental protocols. It is not a dosing, reconstitution, cycle, or self-administration guide.
Short-term IV safety data come from medically complex postoperative patients and cannot establish the safety of chronic outpatient subcutaneous use.