Ovagen

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA

Randomized controlled trials 0 of 0 publications on PubMed

Registered clinical trials 0 0 active

Adverse event reports 4 4 classified as serious

Ovagen is not an FDA-approved drug: Drugs@FDA has no record of it.
PubMed lists 0 publications mentioning it, including 0 randomized controlled trials and 0 animal-only studies.
No study registered on ClinicalTrials.gov tests it as an intervention.
FDA's adverse event system (FAERS) holds 4 reports mentioning it; 4 classified as serious. Reports do not prove causation.

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 0
Human (MeSH) 0
Animal only 0
Clinical trials 0
Randomized controlled trials 0
Systematic reviews & meta-analyses 0
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.

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

Clinical trials

No registered study on ClinicalTrials.gov lists this peptide as an intervention.

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports: 4
Serious: 4
With death outcome: 0

Most reported reactions

Abortion spontaneous 4
Maternal exposure during pregnancy 4

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

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

R18 OVAGEN HUMAN OTC DRUG Apex Energetics Inc. January 8, 2024

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.