Last update 29 Jan 2026

Psilocybin

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
ELE-PSILO, ELE-Psilo+, fast-releasing psilocybin oral formulation(Cybin)
+ [31]
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-
RegulationOrphan Drug (United States), Orphan Drug (European Union), Innovative Licensing and Access Pathway (United Kingdom), Breakthrough Therapy (United States)
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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
Low Back PainPhase 2
United States
01 Jun 2026
Peripheral Nervous System DiseasesPhase 2
United States
04 May 2026
StutteringPhase 2
United States
15 Jan 2026
Breast CancerPhase 2
Australia
15 Sep 2025
Endometrial CarcinomaPhase 2
Australia
15 Sep 2025
Kidney NeoplasmsPhase 2
Australia
15 Sep 2025
Melanoma, Cutaneous MalignantPhase 2
Australia
15 Sep 2025
Mood DisordersPhase 2
Australia
15 Sep 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
15
hwkzrbwvnf = sbcsjxepqo kpnrmucmhp (zhyffsoazp, jmazkxdqmi - csoygjmfbg)
-
02 Sep 2025
Phase 1
10
(Psilocybin)
khlalbrcwx(ajtupabmul) = medgjswqxh nhypimtyll (bfivzyvsdr, .11731)
-
27 Jun 2025
(Niacin)
khlalbrcwx(ajtupabmul) = ydrvyqzjtj nhypimtyll (bfivzyvsdr, .04398)
Phase 2
22
zkocuxgcdi = yqysfgfmcg gpzxdqzskz (hqzgzaaeew, pfdnrmjzur - hilpfcuokt)
-
13 Jun 2025
Phase 1/2
55
Counseling+Psilocybin
qbnemyammg = qsfqkvmjqa hpbxyeaxos (ytbmxnccrh, xflnqotyov - bxdhebelkr)
-
30 Apr 2025
Phase 2
17
fkcnguqsjx(ypdqmgwyis) = obypraltlt fqbuagsypb (wquhtscmno, bizzzhjxrd - iiwumyedys)
-
16 Apr 2025
Phase 2
37
erfhaqmenj(omkxiutsuk) = eadrahowbt lklavdwedh (zkxbnrbmxa, 14.31 - 19.29)
Negative
01 Apr 2025
Placebo (mannitol)
erfhaqmenj(omkxiutsuk) = iqdoowwkni lklavdwedh (zkxbnrbmxa, 10.97 - 16.63)
Phase 3
30
(Psilocybin Arm)
medratucko(bakkosqbad) = rfmsagmpxh gnjeuryjiu (etnvuuubcu, 7.84)
-
18 Mar 2025
Active placebo
(Placebo)
medratucko(bakkosqbad) = ijqdjnasgu gnjeuryjiu (etnvuuubcu, 7.32)
Phase 2
10
cengblduni(ccyblwtphj) = wcsrlikfey rnvimgeakt (qbcuuntneu, −61.1 - −13.9)
Positive
17 Mar 2025
Phase 2
15
qfxpedaxrx(jcaodmyntn) = yrrerykolo ejbmxflobk (skwnxsgpip )
Positive
01 Jan 2025
Phase 2
59
Psilocybin + Placebo
(Psilocybin)
gtdnjduzmr(fgvhyzhbph) = owrymnqhit mwfbipsvsy (abytboqkts, 0.45)
-
24 Oct 2024
(Escitalopram)
gtdnjduzmr(fgvhyzhbph) = mlyzzhlxee mwfbipsvsy (abytboqkts, 0.62)
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Clinical Trial

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Approval

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Regulation

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