Asset profile

CYB003

Small molecule

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Phase 3underway

Evidence outlook · registrational

Major Depressive Disorder: registrational readout pending

Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2027-06-07.

NCT05385783: The study randomized 57 participants and used quadruple masking, with placebo comparator sessions in both the major depressive disorder and healthy-participant groups. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.

Registered primary outcomes are safety measures; the MADRS result is the sponsor-designated primary efficacy endpoint from topline press releases, not yet peer reviewed. Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

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Competitive landscape

66 competitors in this universe: 7 direct rivals (same mechanism and indication), 0 same-class, 59 same-indication; 9 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
CYB003: this drugPhase 3Small molecule5-HT2A receptor
Lysergide Tartrate (LSD) (DT120)Phase 3Small molecule5-HT2A receptor
Psilocybin (COMP360)Phase 3Small molecule5-HT2A receptor
BPL-003 (mebufotenin Benzoate)Phase 2Small molecule5-HT2A receptor
BretisilocinPhase 2Small molecule5-HT2A receptor
Mebufotenin (5-MeO-DMT) (GH001)Phase 2Small molecule5-HT2A receptor
VLS-01Phase 2Small molecule5-HT2A receptor
ELE-101Phase 1/2Small molecule5-HT2A receptor
Brexpiprazole (Rexulti)ApprovedSmall moleculeDopamine D2/D3 and serotonin 5-HT1A receptor
Cariprazine (Vraylar)ApprovedSmall moleculeDopamine D3/D2 receptor (partial agonist)
Cyclobenzaprine (Tonmya)ApprovedSmall molecule5-HT2A, α1-adrenergic, H1-histaminergic, and M1-muscarinic acetylcholine receptors (functional antagonism)
Dextromethorphan / Bupropion (Auvelity)ApprovedSmall moleculesigma-1/NMDA
Esketamine (Spravato)ApprovedSmall moleculeNMDA receptor
Lumateperone (Caplyta)ApprovedSmall moleculeSerotonin 5-HT2A / dopamine D1-D2 receptor
Olanzapine / Fluoxetine (Symbyax)ApprovedSmall moleculeDopamine D2 and serotonin 5-HT2A receptors (antagonist); serotonin transporter (reuptake inhibitor)
Solriamfetol (Sunosi)ApprovedSmall moleculeDopamine/norepinephrine transporter

…and 51 more. Research shows the complete landscape.

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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

(3 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
June 2027 (1)
Phase 3Major Depressive DisorderRecruiting
Est. primary completion 2027-06-07 · NCT06793397 · CT.gov ↗
What to watch
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2028 (2)
June 2028 (1)
Phase 3Major Depressive DisorderEnrolling by invitation
Est. primary completion 2028-06-06 · NCT06605105 · CT.gov ↗
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September 2028 (1)
Phase 2Major Depressive DisorderRecruiting
Est. primary completion 2028-09 · NCT06820723 · CT.gov ↗
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See the full readout calendar ↗

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.