Sermorelin and CJC-1295 are GHRH analogs that act at the pituitary GHRH receptor, while ipamorelin is an agonist at the growth hormone secretagogue receptor, the ghrelin receptor, so the three raise growth hormone by two different routes [6, 20]. Their half-lives span three orders of magnitude: GHRH 1-29 disappears in minutes, ipamorelin has a terminal half-life of about 2 hours, and CJC-1295 with its albumin-binding tail was estimated at 5.8 to 8.1 days in healthy adults [2, 18, 21].
Tesamorelin, the approved GHRH analog, serves below as the comparator for all three across receptor class, pharmacokinetics, approval history, the controlled trial record and the FDA 503A bulk-substance status of each as read on fda.gov on 5 November 2026. It is written for prescribers and practice owners who field these questions, and for patients who type them into a search engine. ExaVeyra Sciences is a supplier, and every decision about whether any of these compounds fits a patient belongs to the prescriber.
Regulatory status
As of 5 November 2026, no sermorelin, CJC-1295 or ipamorelin product is marketed as an FDA-approved drug in the United States; tesamorelin is approved as Egrifta for one indication, and the two Geref sermorelin approvals were withdrawn at the sponsor’s request effective 18 June 2009 [14, 15, 16]. FDA’s safety-risks page, current as of 22 April 2026, lists CJC-1295 and ipamorelin acetate among 503A nominations withdrawn from category 2, keeps ipamorelin acetate in category 2 under the 503B policy, and carries no sermorelin entry [10]. Sermorelin is compounded by our 503A pharmacy partner against a patient-specific prescription; CJC-1295, ipamorelin, tesamorelin and other non-catalog peptides are offered for IND-authorized clinical trials through our pharmacy partner, with the sponsor’s IND number, sponsor details and protocol confirmed before any supply. Whether any of them suits a patient is the prescriber’s decision.
Understanding the two receptor classes behind growth hormone peptides
Growth hormone release is governed by hypothalamic GHRH, by somatostatin as the brake, and by a third input through the growth hormone secretagogue receptor, whose natural ligand is ghrelin, as the 2023 consensus nomenclature statement sets out [6]. Sermorelin is the first 29 amino acids of GHRH, CJC-1295 is a modified GHRH 1-29 carrying a drug affinity complex that binds albumin, and tesamorelin is a stabilized GHRH 1-44 analog, so all three sit in the GHRH class [2, 18].
Ipamorelin belongs to the other class. Raun and colleagues described it in 1998 as a pentapeptide that releases growth hormone through the GHRP receptor, and in swine it left ACTH and cortisol unchanged at doses more than 200 fold above its growth hormone ED50, where GHRP-2 and GHRP-6 raised both [20]. Wang and colleagues reported in 2025 the structures of that receptor bound to macimorelin and anamorelin, two approved drugs, which places ipamorelin in a receptor class that already has regulatory-grade comparators [5].
Feedback differs between the two classes. A GHRH analog depends on an intact pituitary and remains subject to somatostatin [6, 19], while a ghrelin receptor agonist adds a second stimulus and, in the older GHRPs, carried prolactin and cortisol effects that Dominikowski and colleagues tabulated in their 2026 review [2]. The two classes are therefore compared on pharmacology first and on marketing claims never.
Published pharmacokinetics separate the molecules by minutes, hours and days
Wilton and colleagues gave GHRH 1-29, the sermorelin sequence, to 30 healthy men in 1993 and reported that the peptide was rapidly eliminated after intravenous injection while growth hormone stayed elevated for about 3 hours [24]. The 2026 Dominikowski review tabulates sermorelin with a disappearance half-time of about 4.3 minutes, which is why each dose produces a single pulse [2].
Teichman and colleagues ran two randomized, placebo-controlled ascending-dose trials of CJC-1295 in healthy adults and reported in 2006 an estimated half-life of 5.8 to 8.1 days, with growth hormone raised 2 to 10 fold for 6 days or more and IGF-I raised 1.5 to 3 fold for 9 to 11 days after a single injection [18]. Ionescu and Frohman reported the same year that pulse frequency and amplitude were unchanged while trough growth hormone rose 7.5 fold, so the analog lifts the trough while the peaks stay unchanged [19].
Gobburu and colleagues modeled ipamorelin in healthy volunteers in 1999 and reported a terminal half-life of 2 hours, dose-proportional kinetics and a single growth hormone episode peaking at 0.67 hours [21]. The Egrifta label, revised March 2025, states a mean elimination half-life of 11 minutes for tesamorelin and absolute bioavailability below 4 percent after subcutaneous injection, a pulse profile closer to sermorelin than to CJC-1295 [14].
| Compound | Receptor class | Reported half-life | Source | US approval status |
|---|---|---|---|---|
| Sermorelin (GHRH 1-29) | GHRH receptor | Minutes (disappearance half-time about 4.3 min) | Wilton 1993 [24]; Dominikowski 2026 [2] | Geref approved 1990 and 1997, approvals withdrawn 2009 [16] |
| CJC-1295 (with DAC) | GHRH receptor | 5.8 to 8.1 days | Teichman 2006 [18] | Never approved; 503A nomination withdrawn [10] |
| Tesamorelin | GHRH receptor | 11 minutes | Egrifta label 2025 [14] | Approved 10 November 2010 for one indication [15] |
| Ipamorelin | Ghrelin receptor (GHS-R) | About 2 hours | Gobburu 1999 [21] | Never approved; 503A nomination withdrawn, 503B category 2 [10] |
Approval and withdrawal records set sermorelin and tesamorelin apart
FDA’s 2013 Federal Register notice records that EMD Serono held two Geref sermorelin acetate applications, NDA 19-863 approved on 28 December 1990 and NDA 20-443 approved on 26 September 1997, that the sponsor asked in 2008 for both to be withdrawn, and that the withdrawals took effect on 18 June 2009 [16]. After a 2012 citizen petition the agency determined that neither product was withdrawn from sale for reasons of safety or effectiveness, a finding that says nothing about any compounded preparation [16].
Tesamorelin took the opposite path. Drugs@FDA records the original approval of Egrifta, BLA 022505, on 10 November 2010, and the current label states the indication as the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy, with a note that it is not indicated for weight loss management [14, 15]. The approval rests on two 26-week placebo-controlled phase 3 trials with 26-week extensions, which Falutz and colleagues reported in 2007 and pooled in 2010 [22, 23].
Neither CJC-1295 nor ipamorelin has ever been approved anywhere. The CJC-1295 human literature consists of the 2006 pharmacokinetic trials [18, 19], and the only published randomized efficacy trial of ipamorelin located, a 2014 phase 2 study in 114 bowel resection patients, reported no significant difference from placebo on its primary or secondary endpoints [7].
Controlled trials report the clearest outcomes for the approved analog
The question "what is the best growth hormone peptide" is answered here with the evidence for each compound. Badran and colleagues pooled five randomized controlled trials of tesamorelin in 2026 and reported a 27.71 square centimeter reduction in visceral adipose tissue, a 1.42 kilogram increase in lean body mass and a 4.28 percentage point reduction in hepatic fat, with arthralgia, myalgia, paresthesia and injection site erythema among the adverse events and no serious events [1].
Falutz and colleagues reported in 2007 that 26 weeks of tesamorelin reduced visceral adipose tissue by 15.2 percent against a 5.0 percent rise on placebo while IGF-I rose 81 percent, and the 2010 pooled analysis found the reduction maintained at 52 weeks with no clinically meaningful glucose differences [22, 23]. Russo and colleagues reported in 2024 that the effect held in 38 participants on integrase inhibitors, with adverse event frequency similar between groups [8].
For sermorelin, CJC-1295 and ipamorelin the controlled record is thinner. Sigalos and Pastuszak found few long-term, rigorously controlled studies of the secretagogue class in their 2018 review [9], and the 2026 reviews by Mendias and Awan and by Mayfield and colleagues describe rigorous human safety data for the unapproved compounds as scarce and the indications, frequency and duration as unknown [3, 4]. A practice comparing these compounds is comparing one meta-analyzed drug with three molecules characterized mainly by pharmacokinetics.
The useful comparison is between an approved GHRH analog with five randomized trials behind it and three molecules whose human literature is largely pharmacokinetic.
The evidence does not yet show several things practices are asked about
The published record leaves specific gaps, and naming them is part of an honest comparison. Each item below is an absence in the literature as of 5 November 2026, and an absence of evidence carries no finding either way.
- No randomized trial compares sermorelin, CJC-1295 and ipamorelin head to head on any clinical endpoint; the comparison rests on separate pharmacokinetic studies [18, 21, 24].
- No controlled trial of the CJC-1295 with ipamorelin combination exists in humans; the 2026 orthopedic primer traces the pairing to a murine model [4].
- No long-term safety study of any of the three reports cancer incidence or mortality, the gap the 2018 secretagogue review named directly [9].
- No published trial supports body composition or performance claims for sermorelin, CJC-1295 or ipamorelin in healthy adults, as the 2026 endocrinology review concludes [2].
- No sermorelin product has been evaluated by FDA since the Geref approvals were withdrawn in 2009, so the compounded preparation has no agency review behind it [16, 17].
FDA’s 503A pages record each substance’s status as of 5 November 2026
FDA’s safety-risks page, current as of 22 April 2026 and read again on 5 November 2026, lists CJC-1295 in its table of nominations withdrawn from category 2, with the agency’s rationale citing serious adverse events including increased heart rate and systemic vasodilatory reaction and limited clinical data [10]. Ipamorelin acetate appears in both of that page’s tables: its 503A nomination was withdrawn, and it remains in category 2 under the 503B policy, added on 29 September 2023, with a rationale citing a published study in which serious adverse events including death followed intravenous use for gastric motility [10].
Sermorelin appears in none of the three interim category tables of FDA’s nominations list updated 14 May 2026 and has no entry on the safety-risks page [10, 11]. That absence is a fact about the tables and carries no finding of eligibility; because sermorelin acetate was the active ingredient of an approved product, the component route on FDA’s 503A bulks page is the one a pharmacy asks about and should answer in writing [12]. Tesamorelin is the active ingredient of a currently approved drug, so the same page governs it [12].
| Substance | Nominations list (updated 14 May 2026) | Safety-risks page (current as of 22 April 2026) | Source |
|---|---|---|---|
| Sermorelin | In none of the three categories | No entry | FDA [10, 11] |
| CJC-1295 | Not listed | Nominated but withdrawn (previously 503A category 2) | FDA [10, 11] |
| Ipamorelin acetate | Not listed | Withdrawn under 503A; category 2 under 503B since 29 September 2023 | FDA [10, 11] |
| Tesamorelin | Not listed | No entry; approved drug component | FDA [11, 12, 15] |
| Ibutamoren mesylate | Category 2 | Category 2 under 503A and 503B | FDA [10, 11] |
| GHRP-2 and GHRP-6 | Category 3 | Category 2 under 503B | FDA [10, 11] |
The Pharmacy Compounding Advisory Committee met on 23 and 24 July 2026 to discuss BPC-157, KPV, TB-500, MOTs-C, emideltide, Semax and epitalon related substances for the 503A bulks list, and no growth hormone secretagogue was on that agenda; the committee page lists no later 2026 meeting [13]. The codified 503A bulks list at 21 CFR 216.23 names six substances and no peptide, as the eCFR text in force on 18 October 2026 shows [26].
On 30 October 2026 the Secretary of Health and Human Services published a notice of availability for an interim enforcement discretion policy on 503A compounding with certain peptide bulk substances, described in the notice as a draft that is not binding, with comments open on Docket HHS-OASH-2026-0496 to 13 November 2026 [25]. The policy covers BPC-157, epitalon, KPV, MOTS-c, semax and TB-500; sermorelin, CJC-1295, ipamorelin and tesamorelin are outside it, so the status of the four compounds in this article as of 5 November 2026 is the one the FDA tables above record [10, 11, 25, 27]. FDA and HHS revise these pages, and the dates above are the ones a practice re-checks before relying on any status.
Prescription compounding and IND trials are the two supply routes
FDA states that compounded drugs are not FDA-approved, that the agency does not verify their safety, effectiveness or quality before marketing, and that they should only be used in patients whose medical needs cannot be met by an FDA-approved drug [17]. Under section 503A a pharmacy compounds for an identified patient against a valid prescription, using a bulk substance that qualifies by monograph, as a component of an approved drug, or by appearing on the 503A bulks list [12].
Sermorelin is compounded by our 503A pharmacy partner against a patient-specific prescription, and the partner holds nonresident licenses in 33 jurisdictions including Puerto Rico, so state coverage is confirmed through your account manager before a first prescription is sent. CJC-1295, ipamorelin, tesamorelin and other non-catalog peptides are offered for IND-authorized clinical trials through our pharmacy partner, with the sponsor’s IND number, sponsor details and protocol confirmed before any supply.
A verified account places the comparison on documented ground
A practice that keeps the receptor class, the half-life and the FDA status of each compound on file can answer a patient’s "sermorelin vs ipamorelin" question with sources. ExaVeyra supports that work as a supplier: it connects NPI-verified practices with its 503A pharmacy partner for sermorelin and the hormone optimization line, and routes IND-authorized trial requests for non-catalog peptides through the same partner once the sponsor’s IND number, sponsor details and protocol are confirmed.
Anyone may ask the scientific team a question or apply without an NPI, review takes 1 to 3 business days, and NPI verification gives access to the practitioner portal, product documentation and pricing. Product names mentioned in this article are trademarks of their owners and are used only to identify the products discussed. The literature on this axis is growing, the approved comparator shows what a well-run trial program looks like, and practices that document their sourcing today are ready for the better studies to come.
Aviso Educativo: This article is for educational purposes only and does not constitute medical or legal advice. It does not identify any material, compound, device setting or protocol as safe, effective or appropriate for any patient, and it is not intended to diagnose, treat, cure, or prevent any disease. Questions about a treatment belong with the reader’s own licensed provider. Exosome material is supplied for topical aesthetic use by licensed practitioners. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome. Compounded medications are not FDA-approved. They are prepared by a 503A compounding pharmacy licensed by the Texas State Board of Pharmacy for an individual patient against that patient’s prescription, and are available to NPI-verified licensed practitioners only, in the states where the pharmacy is licensed. Product, device and brand names mentioned are trademarks of their respective owners and are used only to identify the products discussed. Their mention is not an endorsement, and those owners have not reviewed or endorsed this article. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, or plan of care. Findings described are attributed to the peer-reviewed literature, trial registries and agencies cited. The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.
Referencias
- 1.Badran AS, Helal A, Shata KS, Ayesh H. Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials. Obes Res Clin Pract. 2026;20(1):2-12. PMID 41545261. doi:10.1016/j.orcp.2026.01.002Meta-analysis of five randomized controlled trials of tesamorelin. Carries in this article: the pooled reduction in visceral adipose tissue (27.71 square centimeters), the increase in lean body mass (1.42 kilograms), the reduction in hepatic fat (4.28 percentage points), and the adverse events the authors list (arthralgia, myalgia, paresthesia and injection site erythema) with no serious events and no perturbation of glucose. Disclosure: none stated in the PubMed record.
- 2.Dominikowski A, Rękoś Z, Olejarz M, Szczepanek-Parulska E, Domin R, Ruchała M. The emerging landscape of performance-enhancing peptides modulating GH-IGF1 axis: bridging the gap between clinical evidence and patient self-administration. Front Endocrinol (Lausanne). 2026;17:1822475. PMID 42395176. doi:10.3389/fendo.2026.1822475Narrative review from an academic endocrinology department, searches to January 2026, read in full text through PubMed Central. Carries in this article: sermorelin described as GHRH 1-29 with a disappearance half-time of about 4.3 minutes, CJC-1295 with DAC with a half-life of 5.8 to 8 days, ipamorelin with a half-life of about 2 hours, the Geref withdrawal date, and the class-level adverse effects the authors tabulate. Disclosure: academic authors; no funding statement in the PubMed record.
- 3.Mendias CL, Awan TM. Safety and Efficacy of Approved and Unapproved Peptide Therapies for Musculoskeletal Injuries and Athletic Performance. Sports Med. 2026;56(8):1921-1935. PMID 41966639. doi:10.1007/s40279-026-02437-0Narrative review covering sermorelin, tesamorelin, CJC-1295, ipamorelin and other peptides marketed direct to patients. Carries in this article: the authors describe rigorous human safety data for the unapproved compounds as scarce. Disclosure: authors affiliated with a private performance medicine institute, as the PubMed record states.
- 4.Mayfield CK, Bolia IK, Feingold CL, Lin EH, Liu JN, Rick Hatch GF, et al. Injectable Peptide Therapy: A Primer for Orthopaedic and Sports Medicine Physicians. Am J Sports Med. 2026;54(1):223-229. PMID 41476424. doi:10.1177/03635465251357593Narrative primer from an academic orthopedic department. Carries in this article: the CJC-1295 with ipamorelin combination is supported only by a murine model, tesamorelin carries no orthopedic evidence, and the authors state that indications, frequency and duration for these peptides remain unknown. Disclosure: none stated in the PubMed record.
- 5.Wang RL, Sun J, Liu H, Guo SM, Zhang Y, Hu W, et al. Molecular recognition of two approved drugs Macimorelin and Anamorelin by the growth hormone secretagogue receptor. Acta Pharmacol Sin. 2025;46(11):2998-3008. PMID 40542284. doi:10.1038/s41401-025-01606-7Structural pharmacology study of the growth hormone secretagogue receptor bound to two approved agonists. Carries in this article: approved drugs already act at the receptor ipamorelin targets, which places ipamorelin in a receptor class with regulatory-grade comparators. Disclosure: academic authors (China); no COI statement in the PubMed record.
- 6.Perelló M, Dickson SL, Zigman JM, Leggio L, Ghrelin Nomenclature Consensus Group. Toward a consensus nomenclature for ghrelin, its non-acylated form, liver expressed antimicrobial peptide 2 and growth hormone secretagogue receptor. J Neuroendocrinol. 2023;35(1):e13224. PMID 36580314. doi:10.1111/jne.13224International consensus statement on nomenclature. Carries in this article: the growth hormone secretagogue receptor is the ghrelin receptor, the second input to growth hormone release alongside GHRH, which is the receptor-class distinction the comparison rests on. Disclosure: consensus group; no funding statement in the PubMed record.
- 7.Beck DE, Sweeney WB, McCarter MD, Ipamorelin 201 Study Group. Prospective, randomized, controlled, proof-of-concept study of the Ghrelin mimetic ipamorelin for the management of postoperative ileus in bowel resection patients. Int J Colorectal Dis. 2014;29(12):1527-34. PMID 25331030. doi:10.1007/s00384-014-2030-8Randomized, placebo-controlled phase 2 trial; 117 enrolled, 114 analyzed. Carries in this article: the only randomized efficacy trial of ipamorelin located, which reported no significant difference from placebo on its primary or secondary endpoints and adverse events of any kind in 87.5 percent of the ipamorelin group against 94.8 percent on placebo. Disclosure: industry-sponsored study group, as the author list states.
- 8.Russo SC, Ockene MW, Arpante AK, Johnson JE, Lee H, Toribio M, et al. Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors. AIDS. 2024;38(12):1758-1764. PMID 38905488. doi:10.1097/QAD.0000000000003965Secondary analysis of a randomized, placebo-controlled 12-month trial; 38 participants. Carries in this article: visceral fat and hepatic fat declines with adverse event frequency similar between groups, including hyperglycemia. Disclosure: two authors report consulting for the manufacturer and others; stated in the PubMed record.
- 9.Sigalos JT, Pastuszak AW. The Safety and Efficacy of Growth Hormone Secretagogues. Sex Med Rev. 2018;6(1):45-53. PMID 28400207. doi:10.1016/j.sxmr.2017.02.004Narrative review of the secretagogue class. Carries in this article: the authors found few long-term, rigorously controlled studies of secretagogues and called for evaluation of long-term safety including cancer incidence. Disclosure: none stated in the PubMed record.
- 10.U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of 22 April 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks (verified 5 November 2026)Agency web page with the category 2 table and the nominated but withdrawn table, read 4 and 5 November 2026. Carries in this article: CJC-1295 in the withdrawn table with the rationale citing increased heart rate and systemic vasodilatory reaction; ipamorelin acetate in both tables, category 2 under the 503B policy since 29 September 2023 with a rationale citing deaths by the intravenous route; ibutamoren in category 2 under both policies; GHRP-2 and GHRP-6 in 503B category 2; no sermorelin or tesamorelin entry.
- 11.U.S. Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (categories 1, 2 and 3). Updated 14 May 2026. https://www.fda.gov/media/94155/download (verified 5 November 2026)Agency list of nominated substances by interim category, a seven-page PDF read 4 and 5 November 2026 (unchanged between reads). Carries in this article: sermorelin, CJC-1295, ipamorelin and tesamorelin appear in none of the three category tables; ibutamoren mesylate sits in category 2; GHRP-2 and GHRP-6 sit in category 3.
- 12.U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act. Content current as of 14 May 2026. https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act (verified 5 November 2026)Agency web page, read 4 and 5 November 2026. Carries in this article: the three routes by which a bulk substance qualifies for 503A compounding (an applicable USP or NF monograph, a component of an FDA-approved drug product, or the 503A bulks list), which is the route question a pharmacy answers in writing for sermorelin.
- 13.U.S. Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. Content current as of 6 August 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 (verified 4 November 2026)Agency meeting page with agenda, read 4 November 2026. Carries in this article: the committee discussed BPC-157, KPV, TB-500, MOTs-C, emideltide, Semax and epitalon related substances for the 503A bulks list, and no growth hormone secretagogue was on the agenda. The committee page lists no later 2026 meeting.
- 14.U.S. Food and Drug Administration. EGRIFTA WR (tesamorelin for injection) prescribing information, BLA 022505, revised March 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022505s020lbl.pdf (verified 4 November 2026)Approved product label, downloaded and read 4 November 2026. Carries in this article: the indication (reduction of excess abdominal fat in HIV-infected adults with lipodystrophy), the mean elimination half-life of 11 minutes, absolute bioavailability below 4 percent, and the label statements on IGF-1, glucose, fluid retention, hypersensitivity (4 percent) and injection site reactions (25 percent against 14 percent on placebo over 26 weeks).
- 15.U.S. Food and Drug Administration. Drugs@FDA record for BLA 022505, EGRIFTA (tesamorelin). Original approval 10 November 2010. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505 (verified 4 November 2026)Agency application record, read 4 November 2026. Carries in this article: the original approval date of 10 November 2010 and the sequence of label revisions through March 2025.
- 16.U.S. Food and Drug Administration. Determination That GEREF (Sermorelin Acetate) Injection ... Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Federal Register. 2013;78(42):14095-14096. FR Doc 2013-04827. Drugs@FDA record: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863 (verified 4 November 2026)Agency notice of 4 March 2013, read in full text through the Federal Register API on 4 November 2026, with the Drugs@FDA record for NDA 019863 read the same day. Carries in this article: NDA 19-863 approved 28 December 1990 and NDA 20-443 approved 26 September 1997, both held by EMD Serono; the sponsor letters of 2008 requesting withdrawal; the withdrawal of both approvals effective 18 June 2009; and the determination that neither product was withdrawn for reasons of safety or effectiveness.
- 17.U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers. Content current as of 16 September 2025. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers (verified 4 November 2026)Agency questions and answers page, read 4 November 2026. Carries in this article: the statements that compounded drugs are not FDA-approved, that FDA does not verify their safety, effectiveness or quality before marketing, and that they should only be used in patients whose medical needs cannot be met by an FDA-approved drug.
- 18.Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA. Prolonged stimulation of growth hormone (GH) and insulin-like growth factor I secretion by CJC-1295, a long-acting analog of GH-releasing hormone, in healthy adults. J Clin Endocrinol Metab. 2006;91(3):799-805. PMID 16352683. doi:10.1210/jc.2005-1536Two randomized, placebo-controlled, double-blind ascending-dose trials of 28 and 49 days in healthy adults aged 21 to 61. Carries in this article: the estimated half-life of 5.8 to 8.1 days, growth hormone raised 2 to 10 fold for 6 days or more, IGF-I raised 1.5 to 3 fold for 9 to 11 days, and no serious adverse reactions reported. Disclosure: first author at a contract pharmacology consultancy and the sponsor among the authors, as the record states.
- 19.Ionescu M, Frohman LA. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog. J Clin Endocrinol Metab. 2006;91(12):4792-7. PMID 17018654. doi:10.1210/jc.2006-1702Frequent-sampling pharmacodynamic study in healthy adults. Carries in this article: pulse frequency and amplitude unchanged, trough growth hormone raised 7.5 fold, mean growth hormone raised 46 percent and IGF-I 45 percent. Disclosure: none stated in the PubMed record.
- 20.Raun K, Hansen BS, Johansen NL, Thøgersen H, Madsen K, Ankersen M, et al. Ipamorelin, the first selective growth hormone secretagogue. Eur J Endocrinol. 1998;139(5):552-61. PMID 9849822. doi:10.1530/eje.0.1390552Preclinical pharmacology paper from the originating company, in rat pituitary cells, rats and swine. Carries in this article: ipamorelin acts through the GHRP receptor, and in swine it did not raise ACTH or cortisol at doses more than 200 fold above the growth hormone ED50, while GHRP-2 and GHRP-6 did. Disclosure: authors employed by the developer, as the affiliation states.
- 21.Gobburu JV, Agersø H, Jusko WJ, Ynddal L. Pharmacokinetic-pharmacodynamic modeling of ipamorelin, a growth hormone releasing peptide, in human volunteers. Pharm Res. 1999;16(9):1412-6. PMID 10496658. doi:10.1023/a:1018955126402Dose-escalation pharmacokinetic study in healthy volunteers. Carries in this article: a terminal half-life of 2 hours, dose-proportional kinetics, and a single growth hormone episode peaking at 0.67 hours after each dose. Disclosure: two authors at the developer, as the affiliations state.
- 22.Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357(23):2359-70. PMID 18057338. doi:10.1056/NEJMoa072375Randomized, placebo-controlled phase 3 trial of tesamorelin over 26 weeks. Carries in this article: visceral adipose tissue fell 15.2 percent against a 5.0 percent rise on placebo, IGF-I rose 81 percent, and more participants on tesamorelin withdrew because of an adverse event. Disclosure: manufacturer-sponsored, as the record states.
- 23.Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, et al. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010;95(9):4291-304. PMID 20554713. doi:10.1210/jc.2010-0490Pooled analysis of the two phase 3 trials with 26-week extension. Carries in this article: visceral fat reduction maintained at 52 weeks, mean IGF-I rise of 108 nanograms per milliliter at week 26, and no clinically meaningful glucose differences at weeks 26 and 52. Disclosure: manufacturer-sponsored, as the record states.
- 24.Wilton P, Chardet Y, Danielson K, Widlund L, Gunnarsson R. Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration. Acta Paediatr Suppl. 1993;388:10-5. PMID 8329825. doi:10.1111/j.1651-2227.1993.tb12827.xPharmacokinetic study of GHRH 1-29, the sermorelin sequence, in 30 healthy men. Carries in this article: the peptide was rapidly eliminated after intravenous injection while growth hormone stayed elevated for about 3 hours, the pulse-then-clear pattern that distinguishes sermorelin from the long-acting analog. Disclosure: authors at the manufacturer of the time, as the affiliation states.
- 25.U.S. Department of Health and Human Services, Office of the Secretary. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances; notice of availability. Federal Register. 2026;91(209):68526-68527. FR Doc 2026-22192. Docket HHS-OASH-2026-0496. https://www.federalregister.gov/documents/2026/10/30/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances (verified 5 November 2026)Agency notice of 30 October 2026, read in full text through the Federal Register API on 5 November 2026. Carries in this article: HHS does not intend to take enforcement action against a state-licensed pharmacy, Federal facility or licensed physician compounding with a peptide in the policy’s Appendix A while the 503A bulks list is developed through rulemaking; the notice describes the policy as a draft that is not binding, and takes comments on regulations.gov for two weeks after publication, to 13 November 2026. The notice names no peptides; the six-peptide scope is cited to the policy document itself [27].
- 26.Electronic Code of Federal Regulations. 21 CFR 216.23, Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act. Last amended 19 February 2019 (84 FR 4710). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-216/subpart-B/section-216.23 (verified 5 November 2026)Codified 503A bulks list, read through the eCFR API on 5 November 2026 for the version in force on 18 October 2026. Carries in this article: paragraph (a) names six substances, none of them a peptide, and paragraph (d) states that a representation that a compounded drug made with a listed substance is FDA approved misbrands the drug.
- 27.U.S. Department of Health and Human Services. HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendix A (interim access list) and Appendix B (identities, route limits and testing standard). 16 pages; read on hhs.gov 4 November 2026. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdfDraft interim policy document, read through a browser on 4 November 2026 (an automated request on 5 November 2026 returned access denied). Carries in this article: Appendix A lists BPC-157, epitalon, KPV, MOTS-c, semax and TB-500, and none of sermorelin, CJC-1295, ipamorelin or tesamorelin.