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Details:
Zurzuvae (zuranolone), the first and only oral, once-daily, 14-day treatment course, has shown to provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3 for women with PPD.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: Zurzuvae
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sage Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2023
Details:
Zurzuvae (zuranolone), a neuroactive steroid GABA-A receptor positive allosteric modulator, is the first and only oral, once-daily, 14-day treatment approved by FDA, that can provide rapid improvements in depressive symptoms for women with postpartum depression.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: Zurzuvae
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2023
Details:
Zurzuvae (zuranolone), a neuroactive steroid GABA-A receptor positive allosteric modulator, is the first and only oral, once-daily, 14-day treatment approved by FDA, that can provide rapid improvements in depressive symptoms for women with postpartum depression.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: Zurzuvae
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 04, 2023
Details:
SAGE-217 (zuranolone) is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). Currently being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sage Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2023
Details:
SAGE-217 (zuranolone) is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). Currently being developed for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 06, 2023
Details:
SAGE-217 (zuranolone) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Zuranolone is an oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM).
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sage Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2022
Details:
Zuranolone 50 mg demonstrated a clinically meaningful and statistically significant improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints as previously reported.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sage Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2022
Details:
Zuranolone (SAGE-217/BIIB125) is a once-daily, 14-day, investigational drug in development for the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
SAGE-217 (zuranolone), 50 mg demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
SAGE-217 (zuranolone) is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator (PAM). The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
SAGE-217/BIIB125 (zuranolone) is a once-daily, two-week, investigational drug in development for treatment of major depressive disorder and postpartum depression. Zuranolone is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 02, 2022
Details:
At the Day 3 primary endpoint, SAGE-217/BIIB125 (Zuranolone), investigational oral neuroactive steroid GABA-A receptor-positive allosteric modulator, 50 mg co-initiated with a standard of care antidepressant showed a statistically significant reduction in depressive symptoms.
Lead Product(s): Zuranolone,Escitalopram Oxalate
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 16, 2022
Details:
Zuranolone (SAGE-217/BIIB125) is an investigational oral neuroactive steroid (NAS) GABA-A receptor positive allosteric modulator being development for the treatment of major depressive disorder and postpartum depression under NEST and LANDSCAPE clinical trial programs.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2021
Details:
Zuranolone has demonstrated a safety profile in the clinical data to date, with no evidence of withdrawal, weight gain, sexual dysfunction, euphoria, or sleep disruption; symptoms that are typically the cause of treatment discontinuation with current antidepressants.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
The findings published in the JAMA Psychiatry showed that after two weeks of daily treatment, women treated with zuranolone had a statistically significant reduction in their core symptoms of depression compared to women who received a placebo.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
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 30, 2021
Details:
Zuranolone is an investigational neuroactive steroid GABA-A receptor positive allosteric modulator. It is intended for oral once-daily use for two weeks.It met the primary goal in the Phase III WATERFALL Study in patients with major depressive disorder.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2021
Details:
The deal would give Biogen rights to a treatment for multiple types of depression, called SAGE-217 or zuranolone, as well as a treatment for essential tremor and other neurological disorders, called SAGE-324.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Biogen
Deal Size: $3,125.0 million Upfront Cash: $1,525.0 million
Deal Type: Collaboration November 27, 2020
Details:
For the primary endpoint of safety and tolerability, the data analyzed to date show that zuranolone was generally well-tolerated in the 30 mg dose and among the initial patients treated with the 50 mg dose.
Lead Product(s): Zuranolone
Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217
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 15, 2020
Details:
Expected regulatory pathway for episodic treatment of major depression remains unchanged with plan for one new additional efficacy study.
Lead Product(s): Zuranolone
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 18, 2020
Details:
The company will be evaluating path forward for the zuranolone (SAGE-217) Landscape Program.
Lead Product(s): Zuranolone
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 27, 2020
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