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GH001 – Our Lead Mebufotenin Program

Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach.

With GH001, we have completed two Phase 1 clinical trials (GH001-HV-101 and GH001-HV-103) in healthy volunteers and a Phase 1/2 clinical trial (GH001-TRD-102) in patients with treatment-resistant depression (TRD).

Ongoing trials with GH001 include a Phase 2b clinical trial in patients with TRD, and Phase 2 open-label trials in patients with bipolar II disorder and postpartum depression.

GH002 and GH003

GH002 is our mebufotenin product candidate formulated for administration via a proprietary intravenous administration approach. In Q4 2023 we successfully completed a Phase 1 clinical trial of GH002 (GH002-HV-105) in 64 healthy volunteers.

GH003 is our mebufotenin product candidate formulated for administration via a proprietary intranasal administration approach. GH003 is currently in preclinical development.

Pipeline

GH001

Mebufotenin for inhalation administration

  • Preclinical
  • Phase 1
  • Phase 2a
  • Phase 2b
  • Phase 3

Treatment-Resistant Depression

Trial Name: GH001-TRD-201; Status: Ongoing; ClinicalTrials.gov ID: NCT05800860

Bipolar II Disorder

Trial Name: GH001-BD-202; Status: Ongoing; ClinicalTrials.gov ID: NCT05839509

Postpartum Depression

Trial Name: GH001-PPD-203; Status: Ongoing; ClinicalTrials.gov ID: NCT05804708

Complete
Current Phase

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GH002

Mebufotenin for i.v. administration

  • Preclinical
  • Phase 1
  • Phase 2a
  • Phase 2b
  • Phase 3

Psychiatric or Neurological Disorder

Trial Name: GH002-HV-105; Status: Completed; ClinicalTrials.gov ID: NCT05753956

Complete
Current Phase

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GH003

Mebufotenin for nasal administration

  • Preclinical
  • Phase 1
  • Phase 2a
  • Phase 2b
  • Phase 3

Psychiatric or Neurological Disorder

Complete
Current Phase

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