Digestive & weight Defensin-mimetic host-defense peptide
Brilacidin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Brilacidin is an investigational defensin-mimetic, a small molecule designed to imitate the body's own host-defense peptides, developed by Innovation Pharmaceuticals for oral mucositis and studied as an antibacterial and antiviral agent. Its human results to date have been reported mainly through company announcements rather than peer-reviewed trials, while published support is largely laboratory-based. As of 2026 it is not approved for any use.
At a glance
- FDA status
- Investigational defensin-mimetic, not approved by the FDA for any use
- Main uses
- Being studied for oral mucositis, bacterial infections, and antiviral uses
- Human evidence
- Peer-reviewed human efficacy data are lacking; positive results are company-reported
- Research
- Published support mostly laboratory and preclinical
- Evidence strength
- Low research
Summary
Brilacidin is an investigational defensin-mimetic studied for oral mucositis and infections. Learn how it works, what research shows, and its approval status.
What is brilacidin?
Brilacidin (brilacidin tetrahydrochloride) is an experimental compound designed to mimic defensins, the naturally occurring host-defense peptides that help fight microbes. It is technically a peptide-mimetic (a small molecule built to reproduce defensin biology) rather than a true peptide. Developed by Innovation Pharmaceuticals under the code PMX-30063, it has been studied as a mouth rinse for oral mucositis and as a potential antibacterial and antiviral treatment. Brilacidin is investigational and not approved.
How does it work?
Brilacidin's proposed actions differ by target:
- Bacteria and fungi: its structure carries a pattern of charge that lets it interact with and disrupt microbial membranes, the proposed basis for its antibacterial and antifungal activity
- Viruses: in laboratory studies against SARS-CoV-2, it has been reported to disrupt the virus and interfere with how it enters cells
- Oral mucositis: an anti-inflammatory action has been proposed
These are mechanisms observed mainly in the laboratory, separate from whether the drug helps patients.
Is it FDA-approved?
Safety note
Status: Investigational defensin-mimetic, not approved by the FDA for any use
Category: In clinical trials · Primary body area: Digestive & weight
No. Brilacidin is investigational across all its studied uses and is not approved. Development has been slow and dependent on partnering and funding, and no confirmatory Phase 3 has been reported as completed.
What does the research show?
Editor’s note
Evidence strength: Low research (2 human · 1 animal/cell studies)
There is no peer-reviewed controlled human efficacy evidence; positive human results exist only as company announcements, with peer-reviewed support confined to laboratory studies.
The published human evidence is limited, and according to PubMed, the peer-reviewed literature is mainly laboratory work. The table sorts the evidence by type:
| Evidence | Setting | Reported result | Peer-reviewed |
|---|---|---|---|
| Oral mucositis Phase 2 trial | Human | Described by the company as positive, in a press-release topline | No |
| COVID-19 Phase 2 trial | Human | Described by the company as positive, in a press-release topline | No |
| Laboratory study | Cell culture | Brilacidin inhibits SARS-CoV-2 | Yes |
| Laboratory study | Laboratory | Shows broad antiviral activity against coronaviruses | Yes |
Without peer-reviewed controlled human efficacy data, its clinical benefit is unestablished.
Sources: laboratory studies of brilacidin against SARS-CoV-2 (Bakovic et al., Viruses, 2021, DOI: 10.3390/v13020271; Hu et al., Journal of Medical Virology, 2022, DOI: 10.1002/jmv.27616), both indexed on PubMed; and Innovation Pharmaceuticals program updates. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
2 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
Compare every peptide’s status in the peptide regulatory status database
More for Digestive & weight
View all digestive & weight peptides →- Not FDA-approved Digestive & weight
5-Amino-1MQ
5-Amino-1MQ is a small-molecule NNMT inhibitor that, in cell studies, increases NAD+ and SAM and suppresses fat production in fat cells. In diet-induced obese mice, a potent NNMT inhibitor reduced body weight and fat mass without changing food intake. As of 2026, no human trials have been published, and it is not a peptide. It is not approved by the FDA.
- In clinical trials Digestive & weight
Amycretin
Amycretin is an investigational single-molecule drug that activates both the GLP-1 receptor and the amylin receptor, being developed by Novo Nordisk in subcutaneous and oral forms for weight management. In a 2025 phase 1b/2a trial of 125 adults with overweight or obesity, the 60 mg group lost 24.3% of body weight at 36 weeks versus 1.1% on placebo (p < 0.0001), though many participants withdrew. As of 2026 it is not approved anywhere and is moving into Phase 3 testing.
- Not FDA-approved Digestive & weight
Aod-9604
AOD-9604 is a modified fragment of the tail end of human growth hormone, developed as a fat-loss drug. Its human obesity trials failed to beat placebo, and development for obesity was halted. As of 2026 it is not FDA-approved and is banned in sport.
- In clinical trials Digestive & weight
Apraglutide
Apraglutide is an investigational long-acting GLP-2 analog, developed by Ironwood Pharmaceuticals as a once-weekly injection for short bowel syndrome, a condition in which people depend on intravenous nutrition because their intestine cannot absorb enough. In a Phase 3 trial it reduced the need for that intravenous support compared with placebo. As of 2026 it is not approved, and the FDA has asked for an additional confirmatory trial.
- Not FDA-approved Digestive & weight
Bpc-157
BPC-157 is a synthetic 15-amino-acid peptide studied for tissue and gut repair, and 35 of the 36 studies in a 2025 systematic review were animal or lab work. The one human report, a retrospective series of 12 patients with chronic knee pain, found that seven (58%) described relief lasting more than 6 months. It had no control group, effect size, or safety data. BPC-157 is not FDA-approved, is prohibited in sport, and remains unsettled in FDA compounding review.
- In clinical trials Digestive & weight
Cagrilintide
Cagrilintide is an investigational long-acting amylin analog, developed by Novo Nordisk as a once-weekly injection for weight management. In a Phase 2 trial, it produced weight loss over 26 weeks, but most of its late-stage development is as the amylin component of the combination drug CagriSema, though a standalone Phase 3 trial has started. As of 2026, cagrilintide is not approved on its own.