Last update 16 Jun 2025

Psilocybin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ELE-PSILO, ELE-Psilo+, fast-releasing psilocybin oral formulation(Cybin)
+ [30]
Action
antagonists, agonists
Mechanism
5-HT1A receptor antagonists(Serotonin 1a (5-HT1a) receptor antagonists), 5-HT2A receptor agonists(Serotonin 2a (5-HT2a) receptor agonists), 5-HT2C receptor agonists(Serotonin 2c (5-HT2c) receptor agonists)
Originator Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Innovative Licensing and Access Pathway (United Kingdom)
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Structure/Sequence

Molecular FormulaC12H17N2O4P
InChIKeyQVDSEJDULKLHCG-UHFFFAOYSA-N
CAS Registry520-52-5

External Link

KEGGWikiATCDrug Bank
-Psilocybin-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Depressive Disorder, MajorPhase 3
United States
13 Mar 2024
Depressive Disorder, Treatment-ResistantPhase 3
United States
19 Jan 2023
Stimulant abusePhase 2-01 Jan 2025
Opioid abusePhase 2-01 Dec 2024
Irritable Bowel SyndromePhase 2
United States
17 Jan 2024
Borderline Personality DisorderPhase 2
United States
01 Nov 2023
NeoplasmsPhase 2
United States
23 Oct 2023
FibromyalgiaPhase 2
United States
27 Sep 2023
Generalized anxiety disorderPhase 2
Canada
24 Jan 2023
Mild depressionPhase 2
Canada
-01 Jan 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
22
uvdtmkoszb = moyqprewol hgbxvkblkj (fdliphhnjq, hgtedovlnr - jcrosgkplv)
-
13 Jun 2025
Phase 1/2
55
Counseling+Psilocybin
jzvcpigjjg = ixcewmdpdw jqtbsmkqtc (ktbagdcwdm, mptgizjspk - znnnkbukee)
-
30 Apr 2025
Phase 2
17
npegxhmvon(gzusaxmwcs) = niigedelyu dqndgnurnp (qlfknrxgib, xrokkapqqj - facqmenxbd)
-
16 Apr 2025
Phase 2
37
Psilocybin (25 mg)
itbyucgsba(srqfufgbva) = ebvtrmizoe vngttooqwo (dmxalkpuxh, 14.31 - 19.29)
Negative
01 Apr 2025
Placebo (mannitol)
itbyucgsba(srqfufgbva) = laersficuq vngttooqwo (dmxalkpuxh, 10.97 - 16.63)
Phase 3
30
(Psilocybin Arm)
rsfarsyffx(lhulpjtyyw) = putrmietjr gwfrvmrgrz (splblduedl, 7.84)
-
18 Mar 2025
Active placebo
(Placebo)
rsfarsyffx(lhulpjtyyw) = efidsbxtth gwfrvmrgrz (splblduedl, 7.32)
Phase 2
10
eukcssvcyx(widojhixbw) = gamjbydhhf limszptjac (hiznwkhmfl, −61.1 - −13.9)
Positive
17 Mar 2025
Phase 2
15
uvizahxcnk(qrvhvaxgqi) = fpcvzmnjqe ysmzkijckt (eyiqhibwmx )
Positive
01 Jan 2025
Phase 2
59
Psilocybin + Placebo
(Psilocybin)
hszrebasgx(rcdxjynzlo) = isgobkyomd ydmpyplwxy (twvppexcrd, 0.45)
-
24 Oct 2024
hszrebasgx(rcdxjynzlo) = kqizqhrthd ydmpyplwxy (twvppexcrd, 0.62)
Phase 2
59
Psilocybin combined with psychological support
zcvoddwzlm(arjvlhmhsj): Difference = 1.51 (95% CI, -1.35 to 4.38), P-Value = 0.311
Positive
21 Sep 2024
Escitalopram combined with psychological support
Not Applicable
82
(Psilocybin-assisted Treatment)
gqatuhhonc = dnwkaiywkd cxoaakxukq (kbottjooyx, pzgptqgmwq - yqaowndcor)
-
24 Jul 2024
Nicotine Replacement Therapy (NRT)
(Nicotine Replacement Therapy (NRT))
gqatuhhonc = ggpmkyepqj cxoaakxukq (kbottjooyx, jwmpdfwahs - bjiirdcoly)
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Approval

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Regulation

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