PeptideTrace
Research CompoundKhavinson Bioregulator Tetrapeptide (Unregulated)

Cardiogen

AEDR

C

Evidence Grade C — Moderate human evidence. 19 published studies, 12 human. 1 registered clinical trial.

1 trial19 studiesUSEUCA

Overview

Cardiogen is a synthetic tetrapeptide from the Khavinson bioregulator programme in Russia, proposed to target cardiovascular tissue. No human clinical trials have been conducted, and it has no approval from any major regulatory agency. The evidence consists entirely of cell culture and animal studies from the originating research group.

Research Activity

19studies
Human 12
Animal 4
Reviews 2

19 published studies: 12 human, 4 animal, 0 in-vitro, 2 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
Not authorised by EMA(EMA)
CA
Not approved by Health Canada(Health Canada)

Legal Status

USPrescription drug (Rx)
EUNot applicable (not authorised)
CANot applicable (not approved)

Summary

Cardiogen has no marketing authorisation from any major regulatory agency. No human clinical trials have been conducted. The evidence base consists of cell culture and animal studies published by the originating research group.

As with other Khavinson bioregulator peptides, the proposed tissue-specific targeting mechanisms and the underlying theoretical framework have not been evaluated through Western regulatory processes. Products available through unregulated channels lack pharmaceutical quality assurance.

Mechanism of Action

Research from the Khavinson group proposes that Cardiogen may stimulate cardiac cell proliferation while suppressing fibroblast growth. These observations are from cell culture experiments and animal models. The proposed mechanisms derive from the Khavinson bioregulation framework and have not been independently validated.

Research Summary

Only 3-5 published studies exist for Cardiogen, virtually all from the Khavinson group. No registered human clinical trials exist. Many key studies are published in Russian-language journals with only abstracts available in English. There are no pharmacokinetic data, no cardiac function measurements from controlled studies, and no independent replication. As with other Khavinson bioregulator peptides, the proposed tissue-specific effects and the underlying theoretical framework have not been evaluated through internationally standardised research processes. Products from unregulated channels lack pharmaceutical quality assurance.

Clinical Trials

NCT01424774N/ACompleted

Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning

Bracco Diagnostics, IncEndpoint: Determination of radiation exposure from Sr-82/Sr-85Completion: 2012-04-01
View all 1 trials on ClinicalTrials.gov →

Regulatory Timeline

1989
Regulatory

FDA ORIG 1

1990
Regulatory

FDA SUPPL 1

1991
Regulatory

FDA SUPPL 2

1997
Regulatory

FDA SUPPL 3

1998
Regulatory

FDA SUPPL 4

1999
Regulatory

FDA SUPPL 5

2001
Regulatory

FDA SUPPL 6

2009
Regulatory

FDA SUPPL 11

2010
Regulatory

FDA SUPPL 12

2012
Regulatory

FDA SUPPL 14

2013
Regulatory

FDA SUPPL 15

2014
Regulatory

FDA SUPPL 16

2019
Regulatory

FDA SUPPL 22

2019
Regulatory

FDA SUPPL 24

2020
Regulatory

FDA SUPPL 21

2024
Regulatory

FDA SUPPL 34

The information on this page is provided for educational and research reference purposes only. This is not medical advice. Always consult a qualified healthcare professional before making any health-related decisions.

Related Compounds

Exenatide

Approved
GLP-1 Receptor Agonist

Exenatide was the first GLP-1 receptor agonist approved anywhere, reaching the market as Byetta in April 2005. The once-weekly formulation Bydureon followed in 2012. Clinical trials showed blood sugar reductions (HbA1c) of 1.6–1.9% and modest weight loss of 2–4 kg. The EXSCEL cardiovascular outcomes trial, involving over 14,700 patients, showed a trend toward cardiovascular benefit but narrowly missed statistical significance. While exenatide was groundbreaking as the first in its class, it has been largely overtaken by newer GLP-1 treatments that offer greater efficacy, less frequent dosing, and proven cardiovascular benefits. It remains available and in clinical use, particularly in combination products.

Lixisenatide

Approved
GLP-1 Receptor Agonist

Lixisenatide was marketed as Adlyxin in the US (approved July 2016), though it has since been discontinued in the US market. The ELIXA cardiovascular trial, involving over 6,000 patients, was the first cardiovascular outcomes trial for any GLP-1 medication to report results. It showed a neutral cardiovascular profile — neither harmful nor beneficial — meeting safety requirements but not demonstrating the heart benefits later shown by semaglutide and liraglutide. Lixisenatide found its primary clinical role in combination with basal insulin, marketed as Soliqua (lixisenatide plus insulin glargine). This combination addresses both fasting blood sugar (via insulin) and post-meal spikes (via lixisenatide) in a single daily injection. As a standalone treatment, it has been largely superseded by more potent GLP-1 medications.

Pramlintide

Approved
Amylin Analogue

Pramlintide is marketed as Symlin (approved March 2005) and remains the only approved amylin-based treatment. It is used alongside mealtime insulin in both type 1 and type 2 diabetes. Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2–0.6%) and approximately 2.3 kg of weight loss — less dramatic than GLP-1 treatments but meaningful as an add-on therapy. Symlin carries a boxed warning for severe hypoglycaemia, particularly when combined with insulin, and requires careful dose adjustment. Practical uptake has been limited by the need for separate injections at each meal alongside existing insulin injections. Despite its modest clinical impact, pramlintide remains the only medication that addresses the amylin deficiency in diabetes, filling a distinct biological role that GLP-1 treatments do not cover.