Nemifitide

Also known as: INN 00835

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 20 publications on PubMed

Registered clinical trials 0 0 active

Adverse event reports 0 0 classified as serious

Nemifitide is not an FDA-approved drug: Drugs@FDA has no record of it.
PubMed lists 20 publications mentioning it, including 6 randomized controlled trials and 1 animal-only study.
No study registered on ClinicalTrials.gov tests it as an intervention.
FDA’s adverse event system (FAERS) has no reports mentioning it.

Research topics

Antidepressive Agents 11
Major Depressive Disorder 7
Psychiatric Status Rating Scales 4
Pilot Projects 3
Area Under Curve 2
Biogenic Monoamines 2
Depression 2
Depressive Disorder 2
Drug Delivery Systems 2
Drugs, Investigational 2

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 20
Human (MeSH) 18
Animal only 1
Clinical trials 8
Randomized controlled trials 6
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.

Latest publications

Emerging targets for antidepressant therapies. Review 2009 Current opinion in chemical biology
Novel targets for antidepressant therapies. Review 2008 Current psychiatry reports
Gateways to clinical trials. Human study 2008 Methods and findings in experimental and clinical pharmacology
Clinical effect of nemifitide, a novel pentapeptide antidepressant, in the treatment of severely depressed refractory patients. Clinical trial 2008 International clinical psychopharmacology
Gateways to clinical trials. Human study 2007 Methods and findings in experimental and clinical pharmacology
Efficacy and safety of 30 mg/d and 45 mg/d nemifitide compared to placebo in major depressive disorder. Randomized controlled trial 2006 The international journal of neuropsychopharmacology
Gateways to clinical trials. Human study 2005 Methods and findings in experimental and clinical pharmacology
Comparison of systemic exposure to nemifitide following two methods of subcutaneous administration to healthy volunteers. Randomized controlled trial 2005 Biopharmaceutics & drug disposition
Gateways to clinical trials. Human study 2005 Methods and findings in experimental and clinical pharmacology
Gateways to clinical trials. Review 2004 Methods and findings in experimental and clinical pharmacology

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

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.