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Lead Product(s): Ibogaine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: DMX-1002
Highest Development Status: Phase I/ Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 10, 2021
Details:
A joint venture between DemeRx and Atai Life Sciences has been cleared by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to start enrolment for a Phase I/IIa trial of ibogaine HCl (DMX-1002) in the treatment of opioid use disorder (OUD).
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Lead Product(s): AB-2004
Therapeutic Area: Psychiatry/Psychology Product Name: AB-2004
Highest Development Status: Phase I/ Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2020
Details:
The findings from the open-label clinical study demonstrated that AB-2004, Axial’s first-in-class, orally administered therapeutic, met the primary endpoint demonstrating safety, tolerability and adherence with no drug-related adverse events.
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Lead Product(s): N,N-Dimethyl-5-methoxytryptamine
Therapeutic Area: Psychiatry/Psychology Product Name: GH001
Highest Development Status: Phase I/ Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
GH001 has the potential to offer an ultra-rapid clearance of symptoms with long-term sustained remission after a single administration session. In the completed Phase 1 healthy volunteer study (GH001-HV-101), GH001 was safe and well-tolerated at the investigated dose levels.
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Lead Product(s): Opioid vaccines
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase II Product Type: Vaccine
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: $33.4 million Upfront Cash: Undisclosed
Deal Type: Funding September 18, 2020
Details:
The award covers funding for two Phase One clinical trials of opioid vaccines developed by UM's Center for Translational Medicine in collaboration with Inimmune Corp. (Dr. Kendal Ryter and Dr. David Burkhart) and the University of Minnesota (Dr. Marco Pravetoni).
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Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
First patient has been enrolled in the Phase 1b/2 RELEASE trial of BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine, for the treatment of opioid withdrawal symptoms.
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Lead Product(s): AB-2004
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase II Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 02, 2020
Details:
The study met the primary endpoint of safety, tolerability and adherence with no drug-related adverse events (AE) reported.
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