gepirone monohydrochloride

Trade name: Exxua

Small moleculeapproved

Approved

Sep 22, 2023

Clinical trial activity

1 trials · 2 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
1
Phase 3
0
Phase 4
0

Earliest trial started Jan 1, 1990 (NCT00000189)

Timeline

1990s

  1. Jan 1, 1990

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Sep 22, 2023

    Kramer — Earliest FDA Approval

  2. Sep 22, 2023

    Kramer — NDA Organization

Indications

Mechanism of action

Approval history

  • approvedSep 22, 2023

Chemistry & pharmacology

Loading structure…

SMILES

CC1(C)CC(=O)N(CCCCN2CCN(c3ncccn3)CC2)C(=O)C1
Mol. weight
359.47 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 4,4-dimethyl-1-(4-(4-(2-pyrimidinyl)-1-piperazinyl)butyl)-2,6-piperidinedione
  • ariza
  • ariza
  • bmy 13805
  • bmy-13805
  • bmy-13805
  • bmy-13805
  • gepirone
  • gepirone
  • gepirone
  • gepirone
  • gepirone
  • gepirone
  • gepirone er
  • gepirone er
  • gepirone er
  • gepirone hcl
  • gepirone hydrochloride
  • gepirone monohydrochloride
  • gepirone monohydrochloride
  • mj 13805
  • mj-13805
  • mj 13805-1
  • org-13011
  • org-13011
  • variza
  • variza

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT00000189Phase 2Jan 1, 1990National Institute on Drug Abuse (NIDA), University of Pennsylvania
Showing 1 of 1 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute on Drug Abuse (NIDA)Government1011990
University of PennsylvaniaAcademic/Hospital1111990
2 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
KramerFor profitNDASep 22, 2023