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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 03, 2021

            Details:

            AZSTARYS contains 30 percent immediate-release d-MPH and 70 percent extended-release novel SDX, a prodrug of d-MPH. After absorption via the gastrointestinal tract, SDX is converted to d-MPH with a design to gradually release d-MPH throughout the day.

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            Lead Product(s): Psilocybine

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 02, 2021

            Details:

            Significant progress made as Numinus-sponsored PRIME study on psilocybin-assisted psychotherapy for opioid, stimulant and/or alcohol use disorders enters pre-implementation stage.

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            Lead Product(s): Nortriptyline

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 25, 2021

            Details:

            Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Nortriptyline Hydrochloride capsules USP, in strengths of 10 mg, 25 mg, 50 mg and 75 mg, Cadila Healthcare said in a regulatory filing.

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            Lead Product(s): S-Ketamine

            Therapeutic Area: Psychiatry/Psychology Product Name: Spravato

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 08, 2021

            Details:

            The European Commission (EC) has authorised the expanded use of Janssen’s Spravato (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of major depressive disorder (MDD).

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            Lead Product(s): Tadalafil

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 31, 2020

            Details:

            Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, the company said in a regulatory filing.

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            Lead Product(s): Buprenorphine Hydrochloride,Naloxone Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: Zubsolv

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 30, 2020

            Details:

            The new patent, US Patent further strengthens the company's intellectual property for ZUBSOLV® in the US. Orexo will now have six patents listed in the Orange Book for ZUBSOLV®.

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            Lead Product(s): Asenapine Maleate

            Therapeutic Area: Psychiatry/Psychology Product Name: Secuado

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 15, 2020

            Details:

            SECUADO achieved the primary endpoint, demonstrating statistically significant improvement in Positive and Negative Syndrome Scale (PANSS) total score change from baseline to Week 6 compared to placebo.