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Details:
Ondansetron Oro-Dispersible Tablet is pleasant and convenient as a tablet that melts in mouth and can be administered anytime anywhere with or without water,is used alone or with other medications to prevent nausea and vomiting caused by cancer drug treatment.
Lead Product(s): Ondansetron
Therapeutic Area: Gastroenterology Product Name: Ondansetron-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2022
Details:
The net proceeds will be used in the clinical development of AD04 (ondansetron), which is a Serotonin 5-HT3a receptor antagonist. It is being evaluated in the clinical trial studies for patients with alcohol use disorder.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co
Deal Size: $3.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 01, 2024
Details:
The Company intends to use the net proceeds to support regulatory and clinical activities related to AD04 (ondansetron), a genetically targeted, serotonin-3 receptor antagonist, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD).
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement October 24, 2023
Details:
The Company intends to use the net proceeds to support regulatory and clinical activities related to AD04 (ondansetron), a genetically targeted, serotonin-3 receptor antagonist, its lead investigational drug product for the treatment of Alcohol Use Disorder (AUD).
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement October 20, 2023
Details:
The Company’s lead investigational new drug product, AD04 (ondansetron), is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Adenomed
Deal Size: $83.0 million Upfront Cash: Undisclosed
Deal Type: Divestment February 01, 2023
Details:
The MKO melt (midazolam) is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an IV in 85% of patients although that number was established anecdotally.
Lead Product(s): Midazolam,Ketamine Hydrochloride,Ondansetron
Therapeutic Area: Ophthalmology Product Name: MKO Melt
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: iOR Partners
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 30, 2022
Details:
AD04 (ondansetron) achieved statistically significant mean reduction in heavy drinking days among pre-specified group of heavy drinkers, compared to placebo, with an approximately 79% reduction from baseline drinking.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 20, 2022
Details:
In studies of Zofran, patients were given AD04 (ondansetron) acutely at dosages up to almost 100 times dosage expected to be formulated in AD04 with the highest doses of Zofran® given intravenously which results in almost twice exposure level as oral dosing.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 18, 2022
Details:
Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 (ondansetron) in patients with Alcohol Use Disorder and selected polymorphisms in the serotonin transporter and receptor genes.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2022
Details:
Clinical trial of AD04 (Ondansetron) for treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking, and no overt safety concerns (there were no statistically significant serious adverse events reported).
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 14, 2022
Details:
The net proceeds of the offering strengthen Adial’s balance sheet as it moves toward completion of the Company’s Phase 3 ONWARD™ trial (AD04) and are intended primarily for working capital and other general corporate purposes.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Maxim Group LLC
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 16, 2022
Details:
ONWARD™ Phase 3 trial evaluating AD04 as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes related to the serotonin transporter and receptor genes.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 20, 2021
Details:
Adial has reached its full enrollment target of 290 subjects in the Company’s ONWARD™ Phase 3 trial evaluating AD04 as a therapeutic agent for the treatment of AUD in persons with certain target genotypes related to the serotonin transporter and receptor genes.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 20, 2021
Details:
The ONWARD trial is a 24-week placebo-controlled, Phase 3 clinical study to evaluate the efficacy, safety and tolerability of AD04 in patients with Alcohol Use Disorder (AUD) and selected polymorphisms in the serotonin transporter and receptor genes.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2021
Details:
AD04 is being developed and undergoing a pivotal Phase 3 trial to treat any adult with AUD with the targeted genetics, Adial believes AD04 holds the potential to effectively and safely treat AUD patients that are adolescents or have ALD.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2021
Details:
ONWARD is investigating the efficacy and safety of Adial’s lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes related to the serotonin transporter and receptor genes.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2021
Details:
Adial previously announced on September 25, 2020, that the Company had submitted a formal request to the FDA in support of Adial’s position that AD04 should be considered eligible for an FDA expedited review program.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2021
Details:
The patent covers the use of the Company's lead product, AD04, as a treatment of Opioid Use Disorder in patients with a specific genetic biomarker in the serotonin transporter gene.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2021
Details:
Each sublingually administered MKO Melt troche contains 3 mg of midazolam, 25 mg of ketamine, and 2 mg of ondansetron, and is available for institutional purchase through Harrow’s wholly-owned subsidiary, ImprimisRx®.
Lead Product(s): Midazolam,Ketamine Hydrochloride,Ondansetron
Therapeutic Area: Neurology Product Name: MKO Melt
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2020
Details:
ONWARD™ is investigating Adial's AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes. 40% of expected Trial patient screenings have been completed.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 03, 2020
Details:
Adial's lead drug candidate, AD04, is a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes and the Company and regulatory advisors have concluded that AD04 is a candidate for this FDA program.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
Details:
AD04 is under development for the treatment of AUD in persons with certain target genotypes related to the serotonin transporter and receptor genes, and is currently the subject of the landmark ONWARD™ Phase 3 trial that initiated in early 2020.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2020
Details:
The Swedish Medical Products Agency and Swedish Ethical Review Authority has provided approval for ONWARD™ to commence in Sweden; and the Estonian State Agency of Medicines and Ethics Review Committee overseeing human trials granted approval to commence ONWARD™ in Estonia.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
Adial has commenced its landmark ONWARD™ pivotal Phase 3 trial to investigate its lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2020
Details:
Adial has received approvals to commence its landmark ONWARD™ pivotal Phase 3 clinical trial in Poland to investigate AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons genotypes related to the serotonin transporter and receptor genes.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: Zofran
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
Adial is conducting ONWARD™ Phase 3 pivotal trial of its lead drug candidate, AD04, in genetically identified subjects for the treatment of Alcohol Use Disorder and plans to enroll 294 trial subjects.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 09, 2020
Details:
AD04 is indicated for people that are positive for select genotypes identified using the Company's propriety companion genetic test.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 26, 2020
Details:
Company is modifying its pivotal Phase 3 clinical trial of the Company's lead drug candidate, AD04, for the treatment of alcohol use disorder (AUD) in genetically targeted patients.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 17, 2020
Details:
ONWARD is Testing Adial's lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes. 40% of expected Trial patient screenings have been completed.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: AD04
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 11, 2020
Details:
The trial is designed to validate Adial's proprietary companion diagnostic genetic test, once validated in the trial, serve to identify patients for treatment in the commercial setting.
Lead Product(s): Ondansetron
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 06, 2020
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