Asset profile
PDC-1421
Botanical
Evidence outlook · lead readout
NCT02395978 · Major Depressive Disorder
The completed lead evidence is positive, with design limits that temper confidence; the rationale below says which.
NCT02395978: The treatment phase was randomized, triple-blind, placebo-controlled, and included 60 participants across three groups, although the groups were small. Its primary clinical endpoint, change in MADRS score at week 6, was not statistically significant compared with placebo, so the findings provide limited evidence of benefit. Label revised to mixed on 2026-09-02: one dose arm shows a numerical advantage the sponsor reports as significant, the other shows none.
The registered primary (MADRS change at week 6 vs placebo, Part II) spans two dose arms: 2-capsule arm -13.19 vs placebo -9.2; 1-capsule arm -9.21 vs -9.2 (registry, ITT, ~20 per arm). The sponsor's 2019-06-05 release reports the high-dose arm met the prespecified primary; the registry results carry no p-values.
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 23 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| PDC-1421: this drug | Phase 2 | Botanical | Polygalae radix extract (active components: tenuifolin, polygalasaponins, etc.) | ||
| Brexpiprazole (Rexulti) | Approved | Small molecule | Dopamine D2/D3 and serotonin 5-HT1A receptor | ||
| Cariprazine (Vraylar) | Approved | Small molecule | Dopamine D3/D2 receptor (partial agonist) | ||
| Cyclobenzaprine (Tonmya) | Approved | Small molecule | 5-HT2A, α1-adrenergic, H1-histaminergic, and M1-muscarinic acetylcholine receptors (functional antagonism) | ||
| Dextromethorphan / Bupropion (Auvelity) | Approved | Small molecule | sigma-1/NMDA | ||
| Esketamine (Spravato) | Approved | Small molecule | NMDA receptor | ||
| Lumateperone (Caplyta) | Approved | Small molecule | Serotonin 5-HT2A / dopamine D1-D2 receptor | ||
| Olanzapine / Fluoxetine (Symbyax) | Approved | Small molecule | Dopamine D2 and serotonin 5-HT2A receptors (antagonist); serotonin transporter (reuptake inhibitor) | ||
| Solriamfetol (Sunosi) | Approved | Small molecule | Dopamine/norepinephrine transporter | ||
| Vortioxetine (Trintellix) | Approved | Small molecule | Serotonin transporter + multiple 5-HT receptors | ||
| Ammoxetine | Phase 3 | Small molecule | Serotonin/norepinephrine transporter | ||
| Ansofaxine Hydrochloride | Phase 3 | Small molecule | Serotonin/norepinephrine/dopamine transporter | ||
| AV-101 | Phase 3 | Small molecule | NMDA receptor | ||
| Azetukalner | Phase 3 | Small molecule | Kv7 potassium channel | ||
| Brenipatide | Phase 3 | Peptide | GLP-1/GIP receptor (dual) | ||
| CYB003 | Phase 3 | Small molecule | 5-HT2A receptor |
…and 45 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Upcoming events
(1 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2028 (1)
February 2028 (1)
What to watch
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.