Sermorelin, tesamorelin, and CJC-1295 are all GHRH-pathway analogs. They are not ghrelin mimetics. They are not three versions of one sequence.
This page is the GHRH analog class: native-length fragments versus an N-acylated GHRH(1-44) analog with an FDA-approved product versus the albumin-binding analog named CJC-1295. The DAC versus no-DAC naming problem is a separate page: CJC-1295 with DAC vs without DAC. GHSR ligands are on Ghrelin mimetics.
Research notice: Research-grade peptides discussed here are not approved for human consumption, medical treatment, or diagnosis. FDA-approved medicines (Egrifta) are separate from research-grade material.
| Parameter | Sermorelin | Tesamorelin | CJC-1295 (literature DAC analog) |
|---|---|---|---|
| Structure in cited sources | GHRH(1-29); shortest synthetic peptide with full GHRH activity (Prakash) | GHRH(1-44) analog with trans-3-hexenoyl at the N terminus (Falutz 2007) | Tetrasubstituted hGRF(1-29) plus C-terminal maleimidopropionyl-lysine (Jette) |
| Receptor | GHRH receptor | GHRH receptor | GHRH receptor |
| Human half-life cited | Native GRH(1-44)-NH2 HPLC t1/2 6.8 min IV (Frohman); not a unique sermorelin PK table here | Mean T1/2 26 min (healthy) and 38 min (HIV-infected) on the 2010 Egrifta label | 5.8-8.1 days (Teichman) |
| US FDA status in cited sources | Geref NDAs withdrawn 2009 (not for safety/effectiveness, 2013 determination) | Egrifta approved November 10, 2010, HIV-associated lipodystrophy (excess abdominal fat) | Not approved |
| Largest human evidence cited here | Review of pediatric diagnostic/treatment literature (Prakash 1999) | Phase 3 HIV lipodystrophy: Falutz 2007 (n=412); pooled Falutz 2010 (n=806) | Healthy-adult PK/PD (Teichman; Ionescu) |
| Direct head-to-head among these three | None in the sources below | None | None |
Guillemin, Brazeau, Bohlen et al. isolated a 44-residue amidated GH-releasing peptide from a human pancreatic tumor that caused acromegaly. Rivier, Spiess, Thorner, and Vale characterized a GH-releasing factor from a human pancreatic islet tumor the same year. Those papers are the GHRH sequence foundation. All three analogs on this page act at the GHRH receptor, not GHSR.
Sermorelin is GHRH(1-29). Prakash and Goa described it as the shortest synthetic peptide with full biological activity of GHRH, used as an IV provocative test of GH secretion and, in limited data, as once-daily subcutaneous treatment in some prepubertal children with idiopathic GH deficiency. Those amounts are historical labeled-product methods, not a research-vial protocol.
Tesamorelin is a synthetic GHRH(1-44) analog with a trans-3-hexenoyl group on the N terminus, intended to last longer than native GHRH(1-44) (Falutz et al., NEJM 2007).
CJC-1295 in the literature is not unmodified sermorelin. Jette et al. identified it as tetrasubstituted hGRF(1-29) plus an albumin-binding maleimide. Teichman and Ionescu measured multi-day GH/IGF-I effects in healthy adults. Details of DAC versus marketplace "no DAC" are on the DAC comparison.
Sermorelin (Geref). NDA 19-863 (0.05 mg diagnostic) was initially approved December 28, 1990. NDA 20-443 (0.5 and 1.0 mg) was initially approved September 26, 1997, for idiopathic GH deficiency in children with growth failure. EMD Serono discontinued the products; FDA withdrew both NDAs effective June 18, 2009. The March 4, 2013 Federal Register notice determined they were not withdrawn for reasons of safety or effectiveness. There is still no current FDA-approved sermorelin product in that record. Compounded or research sermorelin does not inherit Geref's approval.
Tesamorelin (Egrifta). FDA approved tesamorelin for injection on November 10, 2010 (NDA 022505) to reduce excess abdominal fat in HIV-infected patients with lipodystrophy. The 2010 label states it is not indicated for weight-loss management and that long-term cardiovascular benefit has not been studied. The labeled dose of that product is 2 mg subcutaneous once daily. That is a labeled-product fact, not a protocol for research vials.
CJC-1295. Healthy-volunteer PK/PD only in the sources cited. Not an FDA-approved therapeutic.
Research-grade listings are not Geref or Egrifta.
Intact GRH(1-44)-NH2 HPLC half-life in human plasma in vitro was 17 minutes; after IV injection, 6.8 minutes. A GRH(3-44)-NH2 fragment formed and had less than 10^-3 the biologic activity of intact GRH. Short plasma life is the reason later analogs add N-terminal protection (tesamorelin) or albumin tethering (CJC-1295).
The BioDrugs review reports that IV sermorelin 1 microgram/kg was used as a relatively specific provocative test of GH deficiency, and that limited data suggested once-daily subcutaneous sermorelin 30 micrograms/kg at bedtime increased height velocity in some prepubertal children with idiopathic GH deficiency over 12 months. The review states that the effect of that regimen on final adult height was not determined, and that height-velocity increases with sermorelin were less than with somatropin in the comparisons it summarized. Transient facial flushing and injection-site pain were the most commonly reported adverse events. That is a 1999 review of Geref-era literature, not a new trial and not a research-use schedule.
412 HIV-infected patients with abdominal fat accumulation, 26 weeks, tesamorelin versus placebo (NCT00123253). Visceral adipose tissue decreased 15.2% with tesamorelin and increased 5.0% with placebo. Triglycerides fell 50 mg/dL versus a 9 mg/dL rise. IGF-I increased 81.0% versus a 5.0% decrease. Glycemic measures did not differ significantly between groups in that report. More tesamorelin-treated patients withdrew because of an adverse event.
806 ART-treated HIV patients, 2:1 tesamorelin versus placebo for 26 weeks, then a 26-week extension. At week 26, VAT treatment effect -15.4%. Abdominal subcutaneous fat did not change meaningfully. Triglycerides treatment effect -12.3%. Mean IGF-I increased 108 versus -7 ng/mL. In patients who stayed on tesamorelin to week 52, VAT remained below original baseline.
The 2010 Egrifta label reports that from baseline to week 26, HbA1c of 6.5% or higher occurred in 4.5% on tesamorelin versus 1.3% on placebo (hazard ratio 3.3). Mean HbA1c rose 0.12 percentage points versus placebo. Fasting glucose and insulin means were not significantly different at week 26. That glucose-intolerance language is labeled-product safety, not a reason to dose research vials.
Single injection: GH 2- to 10-fold for 6 days or more; IGF-I 1.5- to 3-fold for 9-11 days; half-life 5.8-8.1 days. One week later, overnight pulses persisted; trough GH 7.5-fold; mean GH 46%; IGF-I 45%. Full numbers and the DAC naming issue are on the DAC page.
| Question | Sermorelin | Tesamorelin | CJC-1295 (literature) |
|---|---|---|---|
| Peptide length / modification | GHRH(1-29) | GHRH(1-44) plus N-terminal trans-3-hexenoyl | Tetrasubstituted GHRH(1-29) plus albumin-binding maleimide |
| Human evidence type | Pediatric diagnostic/treatment review (Geref era) | Phase 3 HIV lipodystrophy (VAT, lipids, IGF-I) | Healthy-adult GH/IGF-I and pulsatility |
| Current US approved product | No | Egrifta (narrow HIV-lipodystrophy indication) | No |
| Documented multi-day GH exposure | No in the sources cited | Daily product; plasma t1/2 still minutes on the label | Yes (days) |
| Glucose signal in cited sources | Not the Prakash safety story | Label: more HbA1c 6.5% or higher versus placebo at week 26 | Not the Teichman primary safety story |
If the research question is an approved GHRH analog with phase 3 VAT data in HIV lipodystrophy, tesamorelin/Egrifta is that product. If the question is GHRH(1-29) as historically labeled Geref, sermorelin is that fragment, and it is not currently approved. If the question is multi-day albumin-bound GHRH analog PK in healthy adults, CJC-1295 is the literature molecule.
This site does not currently have separate peptide pages for sermorelin, tesamorelin, or hexarelin. Related: CJC-1295 DAC vs no DAC, Ipamorelin vs CJC-1295, Ghrelin mimetics.
No. These three are GHRH-receptor ligands. GHRP-2, GHRP-6, hexarelin, and ipamorelin act at the ghrelin receptor. See Ghrelin mimetics and Ipamorelin vs CJC-1295 for that split.
Yes, as Egrifta (tesamorelin for injection), approved November 10, 2010, to reduce excess abdominal fat in HIV-infected patients with lipodystrophy. Research-grade tesamorelin listings are not Egrifta. The indication is not general weight-loss approval.
No current Geref product is marketed. FDA approved sermorelin acetate (Geref) in 1990 (diagnostic) and 1997 (idiopathic GH deficiency in children). Approvals were withdrawn effective June 18, 2009, at the company's request. In 2013 FDA determined the products were not withdrawn for reasons of safety or effectiveness. That is not a live NDA.
No. Sermorelin is GHRH(1-29). Literature CJC-1295 is a tetrasubstituted GHRH(1-29) analog with a C-terminal albumin-binding maleimide (Jette 2005). Human half-life in Teichman et al. was 5.8 to 8.1 days. Native GRH(1-44)-NH2 HPLC half-life after IV injection was 6.8 minutes (Frohman et al.).
No. It compares published research and labeled-product facts. It is not medical advice and does not include research-vial dosing protocols.
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