Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Dalargin: what the evidence says

Name: Dalargin
Published: 2026-10-27

At a glance

What it is: a synthetic hexapeptide analogue of Leu-enkephalin developed in the USSR and used there for peptic ulcer disease. ^R1 UNVERIFIED the sequence Tyr-D-Ala-Gly-Phe-Leu-Arg and its current Russian registration status; we did not open a primary source for either.

What the evidence says: in a Soviet trial of 180 men with duodenal ulcer, healing by day 28 was similar to cimetidine (87.5% vs 87.3%). ^R2 In a double-blind trial run to US standards, misoprostol healed ulcers significantly better than dalargin. ^R3

Biggest risks: no major safety signal was reported in the ulcer trials, but safety reporting in this literature is thin. ^R3

Rating


Human Human evidence	Limited: Soviet ulcer trials ^{R2, R4}; one US-standard RCT where it lost to misoprostol ^R3; pancreatitis reports ^{R5, R6}
Animal Animal / lab evidence	Animal pancreatitis models ^R7
Regulatory	Not FDA-approved · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page ^{R8, R9, R10} · not named by WADA ^R11
Established human dose	No (Russian-label use only; see Study details)

Evidence verdict: Duodenal ulcer healing: Limited (Soviet-era trials; lost to misoprostol in a US-standard RCT) · Pancreatitis: Limited (small Russian studies) · Tissue repair or stress protection: Unknown

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: most studies are 1980s–1990s Soviet reports with small or unblinded designs. The best-designed trial found it worse than a standard drug of the time. Ulcer care has since moved to acid-suppressing drugs and H. pylori treatment.

What is it?

A synthetic opioid-peptide analogue that acts mostly outside the brain. ^R1 Related pages: BPC-157, Semax, Selank.

Does it work?

Human Duodenal ulcer: healing similar to cimetidine in one Soviet trial (n = 180) ^R2; healing in 60% of 72 patients with bleeding ulcers in an uncontrolled series ^R4; inferior to misoprostol in a double-blind randomized trial. ^R3
Human Pancreatitis: small Russian reports in chronic pancreatitis flares and postoperative prevention. ^{R5, R6} UNVERIFIED results; abstracts not available.
Human Newer trials: two Russian phase 3 trials (COVID-19; high-risk abdominal surgery) are listed as completed with no posted results. ^{R12, R13}
Unknown Tissue repair, "stress protection" or anti-aging in healthy people: no human data.

Is it safe?

Human In the misoprostol comparison no patient withdrew for side effects. ^R3

Gray-market vials: extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US: not FDA-approved; no Drugs@FDA application found (openFDA searched Oct 26, 2026).
Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. ^{R8, R9, R10}
Sport: not named on WADA's 2026 Prohibited List. ^R11

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
Smagin 1987	180 men, duodenal ulcer	Injection	Per study	28 days	87.5% healed (vs 87.3% cimetidine)	PMID 3554590
Dajani 1991	Duodenal ulcer, double-blind RCT	IM	1 mg twice daily	4 weeks	Misoprostol superior (P = .001)	PMID 1811815
Georgadze 1990	72 patients, bleeding ulcer	IV	3 mg daily	~20 days	60% healed, 8% no effect	PMID 2193190

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Vinogradov VA, et al. Ter Arkh. 1988. PMID 3067406
^R2 Smagin VG, et al. Ter Arkh. 1987. PMID 3554590
^R3 Dajani EZ, et al. J Assoc Acad Minor Phys. 1991. PMID 1811815
^R4 Georgadze AK, et al. Khirurgiia (Mosk). 1990. PMID 2193190
^R5 Geller LI, et al. Ter Arkh. 1992. PMID 1279830
^R6 Grigorevskiĭ VP, et al. Klin Khir (1962). 1989. PMID 2640568
^R7 Georgadze AK, et al. Farmakol Toksikol. 1985. PMID 2416590
^R8 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R9 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R10 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R11 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R12 ClinicalTrials.gov NCT04346693, Burnasyan FMBC phase 3 open-label COVID-19 trial, n = 320, completed 2020, no results posted (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT04346693
^R13 ClinicalTrials.gov NCT07404358, Botkin Hospital phase 3 abdominal-surgery organ-dysfunction trial, n = 200, completed Sep 2026, no results posted (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT07404358

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Dalargin. This compound is not FDA-approved. Any product sold under this name in the US is unregulated. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).