FDA evaluates CJC-1295 and CJC-1295 with drug affinity complex (DAC) as distinct active moieties, with several salt forms.↗
Citation markers ↗ open the public records supporting the adjacent statements.
Correction · September 15, 2026
We clarified that CJC-1295 with DAC is a related, distinct active moiety rather than an interchangeable form. The FDA briefing describes five bulk substances; clinical findings must retain the studied form. 3
Unapproved new drug in cited enforcement record. FDA's 2024 briefing distinguishes five bulk substances and reports that none is a component of an FDA-approved drug. Evidence for a DAC-modified substance cannot automatically establish effects for a non-DAC form.↗↗
Review source snapshots checked September 15, 2026 · Integrity checked September 15, 2026.
Three selected reports examine a long-acting CJC-1295 preparation in healthy adults, including a serum-protein analysis. Hormone and protein measurements are distinct from patient benefit; publication count is not a count of independent cohorts.↗↗↗
What the reviewed sources report
The studies reported sustained growth hormone and IGF-I responses, including preserved hormone pulsatility. They do not establish clinical benefit for injury recovery, body composition or aging, or long-term safety.↗↗
What remains unresolved?
Which findings apply to the exact molecular form and formulation being discussed?↗↗
Do controlled studies demonstrate patient-important benefits and adequately assess longer-term harms?↗↗
FDA assessment dated November 15, 2024 · Read September 15, 2026 · Preserved version 1
FDA's dated evaluation of five CJC-1295-related bulk substances. The briefing distinguishes DAC and non-DAC forms and is an advisory-stage assessment, not a final compounding rule. FDA document ↗
Which human evidence applies?
FDA describes the published studies as short studies of DAC forms in healthy adults. It identifies the 2009 proteomic report as a subset of the earlier Ionescu and Frohman study, rather than an independent participant cohort. FDA pp. 40, 42 ↗
What adverse effects were reported?
FDA reports injection-site reactions, headache, flushing and transient blood-pressure changes in the early studies. Limited exposure in healthy adults cannot establish longer-term safety or safety in growth hormone deficiency. FDA pp. 40, 41, 42 ↗
Why the terminated trial matters
FDA cites anecdotal reports of a death during a terminated HIV-lipodystrophy trial and states that its results were unpublished. This is an agency account of those reports, not proof that CJC-1295 caused the death. FDA pp. 40 ↗
Scope, source pin and remaining work
This summarizes the agency's dated assessment. It is not an independent claim that no evidence exists worldwide or that the briefing is a final regulatory decision. Newer reports and formulation identities require separate screening.
Reviews summarize selected studies; their scope and limitations are shown above.
Research coverage and study families
Search and screening record checked 2026-09-15. Counts describe records, not independent trials. Full-text appraisal is separate from an abstract review.
Primary reports of administered CJC-1295 in people, including pharmacology and secondary analyses; animal, cell, analytical-method, review and online-discourse records retained as exclusions from this human-administration subset. This is not a claim that excluded records have no information value.
33 retrieved · 3 included · 30 excluded · 0 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
"CJC-1295"[Title/Abstract] OR "CJC 1295"[Title/Abstract]
Eligibility decisions use titles and abstracts from the pinned PubMed results; unavailable details remain unresolved rather than inferred.
Full-text appraisal, study-family reconciliation, registry history and broader alias/jurisdiction searches remain separate open work.
Showing 25 of 33 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
PubMed 19386527 — include: Original human administration or secondary human-sample report; full appraisal and study-family reconciliation are separate from this eligibility decision. FDA briefing PDF page 42 (printed page 38) identifies the eleven men in Sackmann-Sala 2009 as a subset of Ionescu and Frohman 2006; these reports are not independent cohorts. Study families: CJC-1295-2006-pulsatility-cohort.Official cohort relationship source ↗.
PubMed 17018654 — include: Original human administration or secondary human-sample report; full appraisal and study-family reconciliation are separate from this eligibility decision. FDA briefing PDF page 42 (printed page 38) identifies the eleven men in Sackmann-Sala 2009 as a subset of Ionescu and Frohman 2006; these reports are not independent cohorts. Study families: CJC-1295-2006-pulsatility-cohort.Official cohort relationship source ↗.
PubMed 16352683 — include: Original human administration or secondary human-sample report; full appraisal and study-family reconciliation are separate from this eligibility decision. Study families: CJC-1295-2006-ascending-studies-linkage-unresolved.
PubMed 42578445 — exclude: Review or evidence overview; not an original report of CJC-1295 administration in people.
PubMed 42395176 — exclude: Review or evidence overview; not an original report of CJC-1295 administration in people.
PubMed 42160466 — exclude: Review or evidence overview; not an original report of CJC-1295 administration in people.
PubMed 42123471 — exclude: Review or evidence overview; not an original report of CJC-1295 administration in people.
PubMed 42021992 — exclude: Review or evidence overview; not an original report of CJC-1295 administration in people.
PubMed 41966639 — exclude: Review or evidence overview; not an original report of CJC-1295 administration in people.
PubMed 41880199 — exclude: Review or evidence overview; not an original report of CJC-1295 administration in people.
PubMed 41490200 — exclude: Review or evidence overview; not an original report of CJC-1295 administration in people.
PubMed 41476424 — exclude: Review or evidence overview; not an original report of CJC-1295 administration in people.
PubMed 41138283 — exclude: Analytical assay or sample-preparation research; the inspected abstract does not report CJC-1295 administration in people.
PubMed 38197510 — exclude: Analytical method with administration samples for other peptides; no CJC-1295 human administration reported in the inspected abstract.
PubMed 37806509 — exclude: Analytical assay or sample-preparation research; the inspected abstract does not report CJC-1295 administration in people.
PubMed 38716080 — exclude: Analytical method with administration samples for other peptides; no CJC-1295 human administration reported in the inspected abstract.
PubMed 35298973 — exclude: Analytical assay or sample-preparation research; the inspected abstract does not report CJC-1295 administration in people.
PubMed 34736642 — exclude: Analytical assay or sample-preparation research; the inspected abstract does not report CJC-1295 administration in people.
PubMed 34665524 — exclude: Analytical assay or sample-preparation research; the inspected abstract does not report CJC-1295 administration in people.
PubMed 32971474 — exclude: Analytical assay or sample-preparation research; the inspected abstract does not report CJC-1295 administration in people.
PubMed 30938069 — exclude: Equine analytical or administration research, outside the human-administration subset.
PubMed 30489688 — exclude: Equine analytical or administration research, outside the human-administration subset.
PubMed 27710891 — exclude: Internet-forum research describes reported use and discourse, without independently verified CJC-1295 exposure or clinical treatment outcomes; retained as a possible separate non-official-source research lead.
PubMed 26879649 — exclude: CJC-1295 administration described in rodents; the human administration example was a different GHRH product.
PubMed 26771670 — exclude: Internet-forum research describes reported use and discourse, without independently verified CJC-1295 exposure or clinical treatment outcomes; retained as a possible separate non-official-source research lead.
ClinicalTrials.gov search
ClinicalTrials.gov API v2 identity-name search, complete retrieved records. Includes protocols, extensions, combinations and expanded access; these are not all efficacy trials or published outcomes.
1 retrieved · 1 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Registry identity screening is distinct from appraisal of posted results, protocol history and publication linkage.
Other registries and unregistered studies are outside this search.
Showing 1 of 1 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
ClinicalTrials.gov NCT00267527 — include: The intervention record names this molecule or its validated development code. Eligibility here is registry identity matching; outcomes and applicability remain separately unappraised. Study families: NCT00267527.
FDA search
Exact active-ingredient terms in the openFDA Drugs@FDA endpoint, checked September 15. A zero result describes this indexed query only, not worldwide nonapproval or every FDA document.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Search terms, record decisions and remaining work
products.active_ingredients.name:"CJC-1295" OR products.active_ingredients.name:"CJC 1295"
This query does not cover all FDA safety communications, labels, compounding proceedings or other regulatory systems.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local identity matching in the pinned EMA medicines metadata feed. This feed is not every national European authorization or every agency document; orphan designation is not marketing authorization.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Complete source-document appraisal and national European sources remain open.
Zero identity matches apply only to these feed fields and terms.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local identity matching in the pinned EMA documents metadata feed. This feed is not every national European authorization or every agency document; orphan designation is not marketing authorization.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Complete source-document appraisal and national European sources remain open.
Zero identity matches apply only to these feed fields and terms.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
EMA search
Local identity matching in the pinned EMA orphans metadata feed. This feed is not every national European authorization or every agency document; orphan designation is not marketing authorization.
0 retrieved · 0 included · 0 excluded · 0 awaiting a decision · 0 full-text appraisals
Complete source-document appraisal and national European sources remain open.
Zero identity matches apply only to these feed fields and terms.
Showing 0 of 0 record decisions, with included studies and unresolved records first. The versioned data inventory retains every record and study-family link.
Read the full Human Evidence Review
Supervised synthesis
What do selected human studies report about CJC-1295?
Three selected reports examine a long-acting CJC-1295 preparation in healthy adults, including a serum-protein analysis. Hormone and protein measurements are distinct from patient benefit; publication count is not a count of independent cohorts.123
Bottom line from this bounded source set
The studies reported sustained growth hormone and IGF-I responses, including preserved hormone pulsatility. They do not establish clinical benefit for injury recovery, body composition or aging, or long-term safety.12
Reviewed study record
Early pharmacology trials in healthy adults
Design
Two blinded randomized placebo-controlled studies assessed pharmacokinetics and hormone responses over 28 and 49 days.1
Population
Participants were healthy adults aged 21–61; the abstract does not state their total number.1
Outcomes reported
Growth hormone and IGF-I concentrations increased for several days. The report recorded no serious adverse reactions.1
Limitations
Short-term hormone changes are surrogate measurements. No serious reactions in these studies does not establish safety over longer exposure or in other populations.1
Reviewed study record
Growth-hormone pulsatility
Design
A before-and-after physiology study measured overnight hormone secretion before and one week after exposure.2
Population
The participants were healthy men aged 20–40; the abstract does not state their total number.2
Outcomes reported
Mean and trough growth hormone levels and IGF-I increased, while pulse frequency and magnitude were unchanged.2
Limitations
The report describes an albumin-binding preparation and physiological endpoints. It does not establish improvement in a clinical condition or comparative long-term safety.2
Reviewed study record
Exploratory serum-protein biomarkers
Design
A before-and-after serum analysis compared samples before exposure and one week afterward.3
Population
Eleven healthy young adult men contributed samples.3
Outcomes reported
The authors identified changes in several protein spots and an association between one spot and IGF-I levels. These were proposed biomarkers.3
Limitations
This small exploratory analysis measured proteins, not clinical benefit. The selected abstract alone does not establish participant overlap; the companion FDA assessment supplies that context.3
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1210/jc.2005-1536. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1210/jc.2006-1702. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/j.ghir.2009.03.001. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
Explore status sources, recent additions, and coverage gaps
Living status brief
What is the current status of CJC-1295?
Unapproved new drug in cited enforcement record. FDA's 2024 briefing distinguishes five bulk substances and reports that none is a component of an FDA-approved drug. Evidence for a DAC-modified substance cannot automatically establish effects for a non-DAC form.↗↗
The cited status sources were checked through July 22, 2026. This answer changes only through the profile’s visible version and correction history.
PeptideScanner currently has no selected clinical trial records and safety records connected to this profile. That is a collection gap, not evidence that no such records exist.
PeptideScanner does not infer an answer where the cited records do not provide one. Open the source-linked records below to inspect their scope and limits.
This map describes PeptideScanner’s selected, source-linked collection. It is not an evidence grade and does not establish research quality, safety, effectiveness, or medical relevance.
0 of 0 selected trial records include at least one phase value; 0 of 0 include a status value in the retained structured contract.
PubMed bibliography
Publication composition
0 of 8 selected PubMed records include attributed title, venue, publication date, and publication-type fields.
Bibliography fields unavailable here for 8 selected records; the records remain visible as metadata observations.
Regulatory and publication surfaces
What is structurally connected?
Drugs@FDA applications
0
FDA Federal Register documents
1
DailyMed SPL versions
0
Canonical profile
Published
Profile structured data
Published
Linked dated records
9
Application counts reflect exact reviewed ingredient connections; Federal Register counts reflect exact reviewed peptide-name matches; DailyMed counts reflect listed SPL versions with retained ZIP receipts. “Published” describes this page’s indexing surface, not the state of scientific evidence.
We clarified that CJC-1295 with DAC is a related, distinct active moiety rather than an interchangeable form. The FDA briefing describes five bulk substances; clinical findings must retain the studied form.
The Federal Register published notice 2024-24828, attributed to FDA and its parent HHS department, on 2024-10-25. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List,” and PeptideScanner's exact reviewed identity mapping connects the document to CJC-1295.
PeptideScanner retained PubMed bibliographic metadata for PMID 17018654 at 2026-07-30T21:09:06.872Z. PubMed recorded a metadata revision date of 2018-12-01 and an Entrez history date of 2006-10-05. PeptideScanner associated this retained record with the identity slug cjc-1295. These dates describe PubMed metadata history, not the article's original publication date.
Counts and links describe PeptideScanner’s selected records. They are not rankings and do not establish research quality, safety, effectiveness, or medical relevance.
These links are based only on overlapping years and evidence lanes in PeptideScanner’s selected records. They do not imply that the peptides are medically or scientifically similar.
These dates come from selected source records and PubMed metadata. They are not a complete or continuous timeline of research, safety, approval, or effectiveness.
Evidence summary
What the cited records say
FDA's 2024 briefing distinguishes five bulk substances and reports that none is a component of an FDA-approved drug. Evidence for a DAC-modified substance cannot automatically establish effects for a non-DAC form.↗
This is a source summary, not a medical recommendation. Status may differ by jurisdiction and product.
PeptideScanner retained PubMed bibliographic metadata for PMID 19386527 at 2026-07-30T18:28:26.873Z. PubMed recorded a metadata revision date of 2025-05-29 and an Entrez history date of 2009-04-24. PeptideScanner associated this retained record with the identity slug cjc-1295. These dates describe PubMed metadata history, not the article's original publication date.↗
The Federal Register published notice 2024-24828, attributed to FDA and its parent HHS department, on 2024-10-25. Its official title is “Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List,” and PeptideScanner's exact reviewed identity mapping connects the document to CJC-1295.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 30938069 at 2026-07-30T20:34:12.987Z. PubMed recorded a metadata revision date of 2020-01-13 and an Entrez history date of 2019-04-03. PeptideScanner associated this retained record with the identity slug cjc-1295. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 30489688 at 2026-07-30T20:43:12.045Z. PubMed recorded a metadata revision date of 2019-12-10 and an Entrez history date of 2018-11-30. PeptideScanner associated this retained record with the identity slug cjc-1295. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 17018654 at 2026-07-30T21:09:06.872Z. PubMed recorded a metadata revision date of 2018-12-01 and an Entrez history date of 2006-10-05. PeptideScanner associated this retained record with the identity slug cjc-1295. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 16352683 at 2026-07-30T21:09:05.761Z. PubMed recorded a metadata revision date of 2018-12-01 and an Entrez history date of 2005-12-15. PeptideScanner associated this retained record with the identity slug cjc-1295. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 26771670 at 2026-07-30T21:35:57.020Z. PubMed recorded a metadata revision date of 2016-12-30 and an Entrez history date of 2016-01-16. PeptideScanner associated this retained record with the identity slug cjc-1295. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 21204297 at 2026-07-30T21:38:23.138Z. PubMed recorded a metadata revision date of 2016-05-11 and an Entrez history date of 2011-01-05. PeptideScanner associated this retained record with the identity slug cjc-1295. These dates describe PubMed metadata history, not the article's original publication date.↗
PeptideScanner retained PubMed bibliographic metadata for PMID 15817669 at 2026-07-30T22:26:16.765Z. PubMed recorded a metadata revision date of 2010-11-18 and an Entrez history date of 2005-04-09. PeptideScanner associated this retained record with the identity slug cjc-1295. These dates describe PubMed metadata history, not the article's original publication date.↗