PeptideTrace
Research CompoundOpioid Peptide Analogue (Russian Approval)

Dalargin

Dalargin, Leu-Enkephalin Analogue

B

Evidence Grade B — Strong clinical evidence. 322 published studies, 115 human. 2 registered clinical trials.

2 trials322 studiesUSEUCA

Overview

Dalargin is a synthetic opioid peptide developed in the Soviet Union in the 1980s for peptic ulcer exacerbations and acute pancreatitis. The clinical evidence base is predominantly from Russian-language publications and has not undergone Western regulatory review.

Research Activity

322studies
Human 115
Animal 194
In-vitro 29
Reviews 9

322 published studies: 115 human, 194 animal, 29 in-vitro, 9 reviews

Regulatory Status

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

Legal Status

USNot applicable (not approved)
EUNot applicable (not authorised)
CANot applicable (not approved)

Summary

Dalargin is approved in Russia for peptic ulcer exacerbations, acute pancreatitis, and pancreatic necrosis. It has not been approved by the FDA, EMA, or other major Western regulatory agencies.

The clinical evidence base is predominantly from Russian publications. The development history spans the 1980s Soviet pharmaceutical research programme. The clinical evidence has not undergone Western regulatory review. Its regulatory status is limited to Russia and certain former Soviet states.

Mechanism of Action

Research suggests dalargin acts on opioid receptors, though its receptor selectivity profile has been debated — initially classified as a delta-opioid agonist, later research suggested preferential mu-opioid activity. Proposed gastroprotective effects include stimulation of mucosal repair processes. These mechanisms are based on pharmacological studies, primarily from Russian institutions.

Research Summary

Research suggests the evidence base for dalargin consists primarily of Russian and Soviet-era literature from the 1980s and 1990s, mostly in Russian-language journals. No internationally standardised clinical trials, no head-to-head comparisons with modern treatments (such as proton pump inhibitors), and no Western regulatory review exist. Over 35 years of clinical use in Russia provides pragmatic evidence of some utility, but this does not constitute rigorous proof by modern international standards. The compound's receptor selectivity remains disputed between different research groups. For these reasons, it is classified as a research compound.

Clinical Trials

NCT07404358Phase IIIActive, Not Recruiting

Dalargin for Prevention of Organ Disfunction in High-Risk Abdominal Surgery

Botkin HospitalEndpoint: Incidence of Major Postoperative ComplicationsCompletion: 2026-12-20
NCT04346693Phase IIICompleted

An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug in Patients With Severe and Critical Manifestations of SARS-COVID-19

Burnasyan Federal Medical Biophysical CenterEndpoint: The change of viral load in patients with SARS-COVID-19.Completion: 2020-11-20
View all 2 trials on ClinicalTrials.gov →

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.