At a glance
- Dalargin is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 322 publications mentioning it, including 5 randomized controlled trials and 194 animal-only studies.
- ClinicalTrials.gov lists 2 registered studies testing it (0 active).
- FDA's adverse event system (FAERS) holds 2 reports mentioning it; 1 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Effect of dalargin on apoptosis of l929 fibroblasts during cold stress.
- Development and Validation of an LC-MS/MS Method for Simultaneous Determination of Short Peptide-Based Drugs in Human Blood Plasma.
- Effect of Leu-Enkephalin Analogue on the Myeloid Compartment of the Blood System in Hypothyroid White Rats under Stress Conditions.
- Lysozyme-dalargin self-organization at the aqueous-air and liquid-liquid interfaces.
- From adsorption to covalent bonding: Apolipoprotein E functionalization of polymeric nanoparticles for drug delivery across the blood-brain barrier.
- Nanoparticles Based on Quaternary Ammonium Chitosan-methyl-β-cyclodextrin Conjugate for the Neuropeptide Dalargin Delivery to the Central Nervous System: An In Vitro Study.
- Improvement of Peptide Affinity and Stability by Complexing to Cyclodextrin-Grafted Ammonium Chitosan.
- New Combined Eye Gel with Alpha-2-Beta Interferon.
- The Bactericidal Activity of Temporin Analogues Against Methicillin Resistant Staphylococcus aureus.
- [The experimental clinical substantiation of treatment of patients with odontogenic phlegmon of maxillofacial area using Dаlargin in complex therapy.].
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 2
- Active
- 0
- With posted results
- 0
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Dalargin for Prevention of Organ Disfunction in High-Risk Abdominal Surgery | Completed | Phase 3 | May 13, 2025 |
| An Open Randomized Study of Dalargin Efectiveness in Combination With Leitragin Drug in Patients With Severe and Critical Manifestations of SARS-COVID-19 | Completed | Phase 3 | April 8, 2020 |
All 2 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2
- Serious
- 1
- With death outcome
- 0
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.