Also known as: INN-00835, Netamiftide
Major depressive disorder (investigational)
Amount
0.2 mg/kg
Frequency
Daily
Duration
5-10 days
Route
SCSchedule
Once daily
Timing
Daily subcutaneous injection for 5 consecutive days; extended protocols use 10 consecutive days
Duration
5-10 days
Repeatable
Yes
CBC with differential
When: Baseline
Why: Baseline blood cell counts
CMP (Comprehensive Metabolic Panel)
When: Baseline
Why: Liver and kidney function baseline
CBC
When: After treatment course
Why: Monitor for any changes during treatment
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Nemifitide (INN-00835) is a synthetic pentapeptide analog of melanocyte-inhibiting factor (MIF-1, also known as Pro-Leu-Gly-NH2). Developed by Innapharma (later Tetragenex), it was designed as a novel antidepressant with a mechanism distinct from SSRIs and other conventional antidepressants.
The compound has a modified amino acid sequence incorporating 4-fluorophenylalanine and trans-4-hydroxyproline, which provide improved receptor binding and metabolic stability compared to the native MIF-1 tripeptide.
Nemifitide acts primarily through modulation of the serotonin 5-HT2A receptor system. Unlike SSRIs, which increase synaptic serotonin by blocking reuptake, nemifitide appears to modulate serotonergic signaling at a receptor level. Preclinical studies also demonstrate effects on dopaminergic and noradrenergic pathways.
The rapid onset of action (5-7 days vs 2-6 weeks for SSRIs) may be related to its direct receptor modulation rather than the gradual neuroadaptive changes required for conventional antidepressants to become effective.
Nemifitide has been evaluated in over 12 clinical trials involving more than 430 subjects. Phase 2 studies demonstrated statistically significant antidepressant effects after 5-10 days of subcutaneous injection at 0.2 mg/kg. The compound showed efficacy in patients who achieved adequate plasma concentrations, with a favorable safety and tolerability profile. Development reached phase 3 but the compound has not been approved.
Nemifitide requires subcutaneous injection and is inactive when taken orally. While clinical data is more extensive than most investigational peptides, the compound has not completed regulatory approval. Efficacy results have been mixed across trials, with plasma concentration appearing to be a key determinant of response.
Clinical pharmacokinetic studies with INN 00835 (nemifitide), a novel pentapeptide antidepressant, published in Biopharmaceutics and Drug Disposition (Nicolau G et al., 2002; PMID: 11891671):
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