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Details:
Betahistine dihydrochloride is an antivertigo agent, which is act as the histamine receptor inhibitor, which is indicated for the reduction of recurrent vertigo episodes associated with Meniere's disease in patients 18 years old and above.
Lead Product(s): Betahistine Dihydrochloride
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: Betahistine Dihydrochloride-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 03, 2023
Details:
AM-125 is a patented intranasal formulation of betahistine dihydrochloride. It has been shown to have 5 to 29 times higher bioavailability than orally administeration. It is being developed for the treatment of acute vestibular syndrome.
Lead Product(s): Betahistine Dihydrochloride
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AM-125
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 15, 2023
Details:
AM-125 is a patented intranasal formulation of betahistine. It has been shown to have 5-to-29 times higher bioavailability than orally administeration. It is being developed for the treatment of acute vestibular syndrome.
Lead Product(s): Betahistine Dihydrochloride
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AM-125
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 12, 2023
Details:
AM-125 is a patented intranasal formulation of betahistine dihydrochloride. It has been shown to have 5-to-29 times higher bioavailability than orally administeration. It is being developed for the treatment of acute vestibular syndrome.
Lead Product(s): Betahistine Dihydrochloride
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AM-125
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, 2023
Details:
In Part B of the TRAVERS trial, the Company will enroll 72 patients who suffer from acute peripheral vertigo following neurosurgery. They are randomized to receive either 10 or 20 mg of intranasal betahistine or a placebo three times daily for four weeks.
Lead Product(s): Betahistine Dihydrochloride
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AM-125
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 May 14, 2021
Details:
First patient has been randomized in Part B of its “TRAVERS” Phase 2 trial of AM-125 (intranasal betahistine) in acute vertigo. This follows the positive read-out from the interim analysis on Part A of the study in early September 2020.
Lead Product(s): Betahistine Dihydrochloride
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AM-125
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 October 13, 2020
Details:
Interim analysis of Phase 2 “TRAVERS” trial demonstrated a dose-dependent improvement in balance as well as good safety and tolerability of ascending doses of AM-125.
Lead Product(s): Betahistine Dihydrochloride
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AM-125
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 03, 2020
Details:
Auris Medical Holding completed patient enrollment into Part A of its Phase 2 “TRAVERS” trial with intranasal betahistine in vertigo (AM-125). The Company expects to release interim results from TRAVERS and commence Part B of the trial in the coming weeks.
Lead Product(s): Betahistine Dihydrochloride
Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: AM-125
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 July 29, 2020
Details:
Last subject had last treatment visit in Phase 1b trial with AM-201 in prevention of antipsychotic-induced weight gain and somnolence; data read-out expected for early May 2020.
Lead Product(s): Betahistine Dihydrochloride
Therapeutic Area: Endocrinology Product Name: Undisclosed
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 March 05, 2020
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