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SPN-817 (Huperzine A) is a novel, first-in-class highly selective acetylcholinesterase (AChE) inhibitor for epilepsy. It is being evaluated in in adult patients with treatment-resistant seizures.
Lead Product(s): Fordine
Therapeutic Area: Neurology Product Name: SPN-817
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 23, 2024
Details:
The agreement aims to seek regulatory approval and commercialize Qelbree, which is approved in the United States is an extended-release formulation of viloxazine, a selective norepinephrine reuptake inhibitor to treat ADHD in adults and children 6 years of age and older.
Lead Product(s): Viloxazine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Qelbree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Moksha8 Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement May 07, 2024
Details:
SPN-830 (apomorphine) is a novel and less invasive therapy, which acts as dopamine D2 receptor agonist, and is investigated for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: SPN-830
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 08, 2024
Details:
SPN-820 is a novel small molecule activator of the mechanistic target of rapamycin complex 1 (mTORC1) currently under phase 2 development for use in major depressive disorder.
Lead Product(s): SPN-820
Therapeutic Area: Psychiatry/Psychology Product Name: SPN-820
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Navitor Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 13, 2024
Details:
SPN-830 (apomorphine) is a novel and less invasive therapy, which is acts as dopamine D2 receptor agonist, which is investigated for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: SPN-830
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 02, 2023
Details:
SPN-830 (apomorphine) is a novel and less invasive therapy, which is acts as dopamine D2 receptor agonist, which is investigated for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: SPN-830
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 09, 2023
Details:
SPN-830 is an investigational apomorphine infusion device under review for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).
Lead Product(s): SPN-830
Therapeutic Area: Neurology Product Name: SPN-830
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 10, 2022
Details:
At daily flexible-dose 200 to 600mg, Phase III trial met primary endpoint showing reduction change from baseline of Adult ADHD Investigator Symptom Rating Scale total score at end of study was statistically significantly greater in adults treated with Qelbree versus placebo.
Lead Product(s): Viloxazine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Qelbree
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 29, 2022
Details:
U.S.FDA notice for company’s NDA, resubmission for SPN-830 for treatment of motor fluctuations in Parkinson’s disease is considered a standard review thereby assigning a timeline of 10 months for review by FDA and establishing a PDUFA target action date in early October 2022.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: SPN-830
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 22, 2022
Details:
Company announced resubmission of NDA for SPN-830 (Apomorphine Hydrochloride) for the continuous treatment of motor fluctuations in Parkinson’s Disease.
Lead Product(s): Apomorphine Hydrochloride
Therapeutic Area: Neurology Product Name: SPN-830
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 08, 2021
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