Long-acting GHRH analogue

CJC-1295 With DAC

CJC-1295 with DAC is a GHRH analogue studied for prolonged stimulation of the GH/IGF-I axis. DAC enables albumin binding, extending exposure compared with short-acting GHRH. Studies in healthy adults measured plasma concentrations and pharmacokinetics; these biomarkers do not demonstrate muscle hypertrophy, increased height or injury recovery.

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Mechanism and findings

Human study · Study formulation · Healthy adults aged 21–61 years

Literature findings; refer to the model and formulation studied.

Mechanism of action

The CJC-1295 investigated in these publications is a GHRH analogue with prolonged binding to endogenous albumin. This feature distinguishes the studied material from commercial designations without DAC; results are not interchangeable between these identities.

GHRH receptor activation stimulates GH secretion and the IGF-I response. Albumin binding prolongs analogue exposure. Teichman and colleagues separated single-administration effects from repeated-administration effects. Ionescu and Frohman assessed pulsatility in a separate experiment using overnight sampling; these results must not be merged into one range.

  • GHRH receptor

Teichman et al., 2006Ionescu et al., 2006

Studied findings 5
Human study · Study formulation

Mean plasma GH

2–10× baseline

Healthy adults aged 21–61 years · For ≥6 days after one administration

View context

Mean plasma GH concentration increased in a dose-dependent manner.

Study design
Two randomized, double-blind, placebo-controlled ascending-dose trials; 28 and 49 days.
Sample scope / arm
Not reported in the abstract
Comparator
Baseline; half-life is a pharmacokinetic estimate, not a between-group effect
Experimental context (not instructions for use)
Clinical study formulation; subcutaneous administration. No commercial variant equivalence established.
Source section / table / abstract
Abstract: Methods and Results

Exposure-dependent results in healthy adults. They do not establish clinical benefit or another formulation’s response. Sample and full methods were not extracted from the complete text.

Teichman et al., 2006

Human study · Study formulation

Mean plasma IGF-I

1.5–3× baseline

Healthy adults aged 21–61 years · For 9–11 days after one administration

View context

IGF-I elevation was dose-dependent in the single-administration experiment.

Study design
Two randomized, double-blind, placebo-controlled ascending-dose trials; 28 and 49 days.
Sample scope / arm
Not reported in the abstract
Comparator
Baseline; half-life is a pharmacokinetic estimate, not a between-group effect
Experimental context (not instructions for use)
Clinical study formulation; subcutaneous administration. No commercial variant equivalence established.
Source section / table / abstract
Abstract: Methods and Results

Exposure-dependent results in healthy adults. They do not establish clinical benefit or another formulation’s response. Sample and full methods were not extracted from the complete text.

Teichman et al., 2006

Human study · Study formulation

Estimated half-life

5.8–8.1 days

Healthy adults aged 21–61 years · Pharmacokinetic assessment

View context

Pharmacokinetic estimate for the long-acting analogue; it is not the duration of a clinical benefit.

Study design
Two randomized, double-blind, placebo-controlled ascending-dose trials; 28 and 49 days.
Sample scope / arm
Not reported in the abstract
Comparator
Baseline; half-life is a pharmacokinetic estimate, not a between-group effect
Experimental context (not instructions for use)
Clinical study formulation; subcutaneous administration. No commercial variant equivalence established.
Source section / table / abstract
Abstract: Methods and Results

Exposure-dependent results in healthy adults. They do not establish clinical benefit or another formulation’s response. Sample and full methods were not extracted from the complete text.

Teichman et al., 2006

Human study · Study formulation

IGF-I after repeated administrations

Above baseline

Healthy adults aged 21–61 years · Up to 28 days in the repeated-dose experiment

View context

In the second trial, two or three weekly or biweekly administrations maintained mean IGF-I above baseline. This result is separate from the 1.5–3-fold range after one administration.

Study design
Two randomized, double-blind, placebo-controlled ascending-dose trials; 28 and 49 days.
Sample scope / arm
Not reported in the abstract
Comparator
Baseline; half-life is a pharmacokinetic estimate, not a between-group effect
Experimental context (not instructions for use)
Clinical study formulation; subcutaneous administration. No commercial variant equivalence established.
Source section / table / abstract
Abstract: Methods and Results

Exposure-dependent results in healthy adults. They do not establish clinical benefit or another formulation’s response. Sample and full methods were not extracted from the complete text.

Teichman et al., 2006

Human study · Study formulation

GH pulsatility

Preserved pulsatility

Healthy men aged 20–40 years · One week after one administration

View context

Pulse frequency and magnitude were unchanged. Trough GH increased 7.5-fold (P<0.0001), with mean GH 46% higher (P<0.01) and IGF-I 45% higher (P<0.001). These values belong to a different experiment from the Teichman trial.

Study design
Sampling every 20 minutes over 12 overnight hours, before and one week after administration.
Sample scope / arm
Not reported in the abstract
Comparator
Baseline sampling in the same experiment
Experimental context (not instructions for use)
CJC-1295; experimental groups of 60 or 90 µg/kg. Studied exposure, not instructions for use.
Source section / table / abstract
Abstract: Methods and Results

Exposure-dependent results in healthy adults. They do not establish clinical benefit or another formulation’s response. Sample and full methods were not extracted from the complete text.

Ionescu et al., 2006

What the literature explores
GH/IGF-I axis
Plasma concentrations and exposure dependence in healthy adults.Teichman et al., 2006
Albumin binding and pharmacokinetics
Analogue exposure duration, distinct from the duration of a clinical response.Teichman et al., 2006Ionescu et al., 2006
Pulsatility
Frequency, magnitude and trough concentrations assessed with overnight sampling.Ionescu et al., 2006
Sources and studies 2Peptide Monographs
  1. 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.

    Teichman SL, Neale A, Lawrence B, Gagnon C, Castaigne JP, Frohman LA · 2006 · The Journal of clinical endocrinology and metabolism

    DOI: 10.1210/jc.2005-1536
  2. Pulsatile secretion of growth hormone (GH) persists during continuous stimulation by CJC-1295, a long-acting GH-releasing hormone analog.

    Ionescu M, Frohman LA · 2006 · The Journal of clinical endocrinology and metabolism

    DOI: 10.1210/jc.2006-1702

Specifications and packaging

Nominal variant content; analytical results belong to the documented batch.

Material type
Peptide

Quality and analyses

Review specifications, analytical results and documentation for published batches.

Purity
>99%
Type
Declared specification

Published batches

Batch results have not yet been published on this page.

Storage

Consult the specific conditions in the supplied material documentation.

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