Educational reference, not medical advice. This page summarizes information from published research and regulatory filings for educational purposes. It is not a recommendation to use any compound and should not replace guidance from a licensed healthcare provider. Most peptides discussed here are not approved for the uses described.
What it is
Tesamorelin + Ipamorelin is a commercial pre-mixed combination of two growth-hormone-axis peptides supplied by compounding pharmacies and research-peptide vendors. The pairing combines a GHRH analog with a ghrelin-receptor agonist:
- Tesamorelin is a 44-amino-acid synthetic analog of human GHRH developed by Theratechnologies and approved by the FDA in 2010 under the brand name Egrifta for the reduction of excess abdominal fat in HIV-associated lipodystrophy. It binds the GHRH receptor and stimulates pulsatile GH release.
- Ipamorelin is a five-amino-acid selective agonist of the ghrelin (growth hormone secretagogue) receptor characterized by Novo Nordisk researchers in 1998. It stimulates GH release without significantly affecting cortisol or prolactin.
The combination concept parallels the more common CJC-1295 + Ipamorelin blend: pair a short-acting GHRH agonist with a short-acting ghrelin agonist to produce a larger GH pulse than either component alone. Substituting Tesamorelin for CJC-1295 swaps a non-approved GHRH analog for an FDA-approved one.
History
- Tesamorelin was developed by Theratechnologies and reached FDA approval in November 2010 based on the Falutz pivotal trials in HIV-associated lipodystrophy. Long-term safety extensions and visceral fat reduction data have been published through 2011.
- Ipamorelin has not progressed to marketing approval. It has Phase I and Phase II data, with most published characterization coming from the 1998–1999 Raun and Gobburu papers, and remains in the research and investigational space.
The combined blend appeared in compounding-pharmacy preparations in the mid-2010s. The pair has not been studied as a single product in any registered trial.
Regulatory status
- Tesamorelin (Egrifta): FDA-approved for HIV-associated lipodystrophy. Distributed by prescription in the United States and approved in several other jurisdictions. Off-label use outside the approved indication occurs.
- Ipamorelin: Investigational; no FDA approval. Listed on the WADA prohibited list under S2.
- Combination: Not an approved product. Compounding-pharmacy preparations exist in some U.S. states; the FDA has actively restricted compounding of peptides not on its 503A bulks list, and supply varies with regulatory enforcement.
How researchers describe its action
The two components target different receptors in the pituitary GH axis:
- Tesamorelin binds the GHRH receptor and stimulates GH release in pulsatile fashion mimicking endogenous GHRH. In Phase III HIV-lipodystrophy trials, weekly dosing at 2 mg subcutaneously reduced visceral adipose tissue and improved triglyceride and lipid markers compared with placebo.
- Ipamorelin binds the ghrelin receptor (GHSR-1a) and stimulates GH release through a complementary pathway. Unlike non-selective GHRPs, it does not appreciably stimulate cortisol or prolactin at typical doses.
When GHRH and ghrelin agonists are co-administered, published pituitary cell studies show a more-than-additive GH release. This is the published rationale for the combined blend; however, no controlled clinical trial has evaluated Tesamorelin + Ipamorelin specifically.
Half-life and dosing intervals
- Tesamorelin: approximately 8–13 minutes circulating half-life (its kinetic profile is pulsatile, consistent with endogenous GHRH).
- Ipamorelin: approximately 2 hours circulating half-life.
The FDA label for Egrifta specifies 2 mg subcutaneously daily for HIV-associated lipodystrophy. Observational protocols for the combined blend typically describe once-daily subcutaneous dosing — frequently before sleep to coincide with the natural nocturnal GH pulse — with per-injection masses in the range of 1–2 mg of Tesamorelin and 100–300 mcg of Ipamorelin.
Reconstitution example
A combined vial containing 5 mg of Tesamorelin and 5 mg of Ipamorelin reconstituted with 2 mL of bacteriostatic water yields a total peptide concentration of 5 mg/mL — 2.5 mg/mL of each component. On a 1 mL U-100 insulin syringe, 10 units (0.10 mL) delivers 0.5 mg of total peptide, split as 0.25 mg of each component.
The Egrifta-branded product ships in sterile single-use vials with manufacturer-specified diluent. Compounded versions vary by pharmacy and require the supplier's reconstitution protocol.
What to know
- Components have different approval status. Tesamorelin is FDA-approved for a specific indication. Ipamorelin is not approved for any indication. The combination is not an approved product.
- No combined clinical trial. The pair has not been evaluated as a single product in any registered study. All efficacy data must be referenced to component literature.
- Compounding access. Tesamorelin is available as Egrifta by prescription; compounded versions exist but face increasing FDA restriction.
- WADA-banned. Ipamorelin is prohibited under WADA S2; Tesamorelin is also classified under the same category. Athletes subject to testing should not use either.
- Storage. Refrigerate lyophilized vials. After reconstitution, refrigerate and use within the manufacturer's or compounder's stated stability window.
- Reported side effects. The Egrifta label cites injection-site reactions, arthralgias, peripheral edema, and hyperglycemia as the most common adverse events in pivotal trials. Combination-specific safety has not been characterized.
Sources
- 1.Falutz J et al. (2007). Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine.
- 2.Falutz J et al. (2010). Effects of tesamorelin in HIV-infected patients with excess abdominal fat: pooled analysis of two phase 3 trials. JCEM.
- 3.Raun K et al. (1998). Ipamorelin, the first selective growth hormone secretagogue. European Journal of Endocrinology.
- 4.Gobburu JV et al. (1999). Pharmacokinetic-pharmacodynamic modeling of ipamorelin in human volunteers. Pharmaceutical Research.
- 5.FDA Prescribing Information — Egrifta (tesamorelin) injection.