Iseganan

Also known as: IB-367

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 6 of 59 publications on PubMed
Registered clinical trials 2 0 active
Adverse event reports 0 0 classified as serious
  • Iseganan is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 59 publications mentioning it, including 6 randomized controlled trials and 7 animal-only studies.
  • ClinicalTrials.gov lists 2 registered studies testing it (0 active).
  • FDA’s adverse event system (FAERS) has no reports mentioning it.

Research topics

  • Antimicrobial Cationic Peptides 33
  • Anti-Bacterial Agents 17
  • Microbial Sensitivity Tests 16
  • Stomatitis 16
  • Mouth Mucosa 13
  • Anti-Infective Agents 12
  • Antineoplastic Agents 7
  • Antifungal Agents 6
  • Bacteria 6
  • Bacterial Infections 6

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

  • All publications 59
  • Human (MeSH) 41
  • Animal only 7
  • Clinical trials 6
  • Randomized controlled trials 6
  • Systematic reviews & meta-analyses 6
  • Case reports 0
  • Retracted 0

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

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
2
Active
0
With posted results
0

Conditions studied

  • Pneumonia 1
  • Head and Neck Cancer 1
  • Oral Complications of Radiation Therapy 1
  • Radiation Toxicity 1
Study Status Phase Start
Trial of Iseganan in Prevention of Ventilator-Associated Pneumonia
NCT00118781 IntraBiotics Pharmaceuticals
Terminated Phase 2, Phase 3 Sep 2003
Iseganan Hydrochloride in Preventing Oral Mucositis in Patients Who Are Undergoing Radiation Therapy for Head and Neck Cancer
NCT00022373 National Cancer Institute (NCI)
Unknown status Phase 3 Dec 2000

All 2 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

No FAERS reports mention this peptide.

Source: FDA FAERS · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.