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Details:
Dr. Reddy’s Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is available in 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 50 mL and 100 mL clear glass vials, respectively.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: Dexmedetomidine Hydrochloride-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 September 25, 2020
Details:
BXCL501 (dexmedetomidine HCl) is an adrenergic receptor alpha-2 agonist, small molecule drug candidate, which is currently being evaluated for the treatment of agitation associated With alzheimer’s dementia.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: Igalmi
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 10, 2024
Details:
The Company intends to use the net proceeds to fund planned clinical trials of BXCL501 (sublingual dexmedetomidine), being evaluated for the treatment of Opioid Use Disorder.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering March 25, 2024
Details:
Through termination. the company intends to focus on the commercialization of Igalmi (dexmedetomidine). It is approved by the FDA for the treatment of acute treatment of agitation associated with schizophrenia and associated bipolar I or II disorder.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Igalmi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: BofA Securities
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Termination February 13, 2024
Details:
The company intends to use the net proceeds to fund ongoing clinical trials and commercialization of its approved product, including Igalmi (dexmedetomidine), indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Igalmi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: BofA Securities
Deal Size: $60.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 08, 2024
Details:
BXCL501 (sublingual dexmedetomidine) is a selective alpha-2 adrenergic receptor agonist, which is investigated for the treatment of Opioid Use Disorder.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 06, 2023
Details:
BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist and potentially targets an important mediator of Alzheimer’s Disease-Related Agitation.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: BXCL501
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 October 25, 2023
Details:
Igalmi (dexmedetomidine) sublingual film is a prescription medicine, which is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: Igalmi
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 October 04, 2023
Details:
Through the acquisition, Azurity gains access to Slayback's pipeline including, Precedex (dexmedetomidine hydrochloride), an alpha2-adrenergic agonist with sedative properties used for short-term intravenous sedation.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: Precedex-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Azurity Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition September 27, 2023
Details:
BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist and potentially targets an important mediator of Alzheimer’s Disease-Related Agitation.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: BXCL501
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cognitive Research Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2023
Details:
TPU-006 is an investigational transdermal system that delivers dexmedetomidine, a selective α2-adrenergic agonist, for up to four days from a single application, which is investigated for the treatment of Post Operative Pain.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: TPU-006
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2023
Details:
Dexmedetomidine hydrochloride Injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: Precedex-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 June 09, 2023
Details:
BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist and potentially targets an important mediator of agitation.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
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 May 25, 2023
Details:
BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine hydrochloride, a selective alpha-2 adrenergic receptor agonist, which is being investigated for major depressive disorder.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2023
Details:
BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 potentially targets an important mediator of agitation.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: BXCL501
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 December 19, 2022
Details:
BXCL501 is a proprietary, orally dissolving film formulation of dexmedetomidine, selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
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 30, 2022
Details:
BXCL501 (dexmedetomidine hydrochloride) was generally well tolerated, with no severe or serious adverse events reported across all doses evaluated (30 mcg, 60 mcg, 90 mcg, 120 mcg, 180 mcg and 240 mcg).
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institute on Drug Abuse
Deal Size: $7.8 million Upfront Cash: Undisclosed
Deal Type: Funding August 01, 2022
Details:
BXCL501 (dexmedetomidine hydrochloride), demonstrated statistically significant reductions in agitation measures with both the 30 and 60 mcg doses as measured by multiple scales with no severe or serious adverse events.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
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 May 03, 2022
Details:
The financing is intended to support the commercial activities of IGALMI™ (dexmedetomidine) sublingual film and clinical development efforts of BXCL501, which includes a pivotal Phase 3 program for the acute treatment of agitation in patients with Alzheimer’s Disease (AD).
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Igalmi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Oaktree Capital
Deal Size: $125.0 million Upfront Cash: Undisclosed
Deal Type: Financing April 19, 2022
Details:
Igalmi (dexmedetomidine), sublingual film for acute treatment of agitation associated with schizophrenia or bipolar disorder in adults, demonstrated onset of action as early as 20 minutes and high response rate with both 120 mcg and 180 mcg doses in pivotal studies.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Igalmi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
Company’s neuroscience and immuno-oncology programs, artificial intelligence platform used to augment and accelerate the drug candidate discovery and development process, and its commercial and launch readiness plans for its product candidate, BXCL501.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
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 09, 2022
Details:
BXCL502 is emerging program to bolster Company’s novel neuroscience portfolio, and review expansion of Company’s most advanced clinical development program, BXCL501, a proprietary, orally dissolving thin film formulation of dexmedetomidine, an alpha-2a receptor agonist.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2021
Details:
BXCL501 is a dexmedetomidine thin film formulation that dissolves in the mouth. Following its Phase 2 meeting with the FDA, the Company expects to have finalised study design, dosing, and endpoints for its Phase 3 registrational programme, by the second half of 2021.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2021
Details:
The event aims to highlight BXCL501, the Company’s investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine (“Dex”), and its potential as a treatment option for multiple neuropsychiatric conditions.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cognitive Research Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2021
Details:
Aurobindo's dexmedetomidine HCl in 0.9% sodium chloride injection is a therapeutic equivalent generic version of Hospira's Precedex in 0.9% sodium chloride injection.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: Dexmedetomidine Hydrochloride-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 December 09, 2020
Details:
BXCL501 was well tolerated in both SERENITY trials. Overall, the most commonly reported adverse events from both trials were somnolence, dry mouth, and dizziness.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
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 11, 2020
Details:
BXCL501 is an investigational, proprietary, orally dissolving, sublingual thin film formulation of dexmedetomidine, for the treatment of acute agitation. The Company plans to initiate a Phase 2 trial within the next several months.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
BXCL501, the Company’s proprietary sublingual thin film of dexmedetomidine, met the primary and secondary endpoints of SERENITY I and SERENITY II, demonstrating a robust treatment effect in the trials.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
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, 2020
Details:
Company has initiated an expanded access program at Massachusetts General Hospital to provide its investigational drug, BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine to critically ill patients diagnosed with COVID-19.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
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 09, 2020
Details:
Patent is related to BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine (“Dex”). The patent is expected to cover film formulations containing Dex and methods of treating agitation using such film formulations.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: BXCL501
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 07, 2020
Details:
Vizient has signed an agreement with Pfizer to add six drugs identified as “essential medications” to its Novaplus® Enhanced Supply Program, part of Vizient’s private label pharmacy solution.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: Precedex
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement June 22, 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.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
SERENITY I is evaluating patients with agitation associated with schizophrenia, with each of three arms receiving BXCL501 at 120 micrograms, 180 micrograms or placebo.
Lead Product(s): Dexmedetomidine Hydrochloride
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 May 14, 2020
Details:
More than one-third of the SERENITY I & II patients have been dosed, including over 100 bipolar patients.
Lead Product(s): Dexmedetomidine Hydrochloride
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 19, 2020
Details:
The Company intends to use the net proceeds of this offering to advance the development of product candidates, including the funding of clinical trials for BXCL501.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BofA Securities
Deal Size: $64.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 19, 2020
Details:
The Phase 2 study by researchers at Yale University is designed to measure biomarkers associated with agitation in patients with schizophrenia and the response to treatment with BXCL501.
Lead Product(s): Dexmedetomidine Hydrochloride
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 18, 2020
Details:
The FDA clearance of the IND application for opioid withdrawal, is an important step in BioXcel's plans to build a neuroscience franchise around the multiple therapeutic opportunities with BXCL501.
Lead Product(s): Dexmedetomidine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 05, 2020
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