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Details:
Pimavanserin tablet is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors, which is used treatment for Parkinson's disease.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid-Generic
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 January 27, 2022
Details:
Nuplazid (pimavanserin) is an atypical antipsychotic 5-HT2A receptor inverse agonist, which is being evaluated for the treatment of patients with schizophrenia.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 11, 2024
Details:
Nuplazid (pimavanserin) is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors, which is used treatment for Parkinson’s disease-related hallucinations and delusions who also have dementia.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Neurology Product Name: Nuplazid
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 18, 2023
Details:
NUPLAZID (Pimavanserin) is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors and prevents psychosis symptoms associated with Parkinson's Disease Psychosis.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2023
Details:
Nuplazid (pimavanserin) is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors, demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 August 04, 2022
Details:
Nuplazid (pimavanserin) is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors, which is used Treatment of Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 August 04, 2022
Details:
Nuplazid (pimavanserin) is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors, which is used Treatment of Alzheimer’s Disease Psychosis.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 17, 2022
Details:
ACP-103 (pimavanserin) is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors, demonstrated no appreciable binding affinity for dopamine, histamine, muscarinic, or adrenergic receptors in vitro.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 02, 2022
Details:
ACP-103 (pimavanserin tartrate) is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: ACP-103
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:
Resubmission for Nuplazid (pimavanserin) provides additional analyses from two previously conducted clinical studies, HARMONY1 and Study -0192, to support a proposed indication for treatment of ADP and is intended to address issues raised in FDA’s CRL.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Neurology Product Name: Nuplazid
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 16, 2022
Details:
Pimavanserin Capsule is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors, which is used treatment for Parkinson's disease.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Neurology Product Name: Nuplazid-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 31, 2021
Details:
Pimavanserin tablet is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors, which is used treatment for Parkinson's disease
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Neurology Product Name: Nuplazid-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 22, 2021
Details:
Nuplazid (pimavanserin) is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors, which is used treatment for hallucinations and delusions associated with dementia focused on Alzheimer’s disease psychosis.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Neurology Product Name: Nuplazid
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 20, 2021
Details:
Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Neurology Product Name: Nuplazid
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, 2021
Details:
The data from the HARMONY study demonstrates that patients with DRP who had responded to pimavanserin had a significantly lower risk of relapse of psychosis with continuation of pimavanserin compared to placebo up to 26 weeks.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 21, 2021
Details:
Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 14, 2021
Details:
The OLE study was designed to evaluate the long-term safety of NUPLAZID. All patients in the OLE were treated with NUPLAZID 34 mg. Of 459 patients enrolled in the OLE, 424 (92.4%) had a Week 4 efficacy assessment.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 03, 2021
Details:
The DRP pivotal HARMONY study met its prespecified primary and secondary endpoints with robust and persuasive clinical and statistical superiority of pimavanserin over placebo, which was a prospectively agreed prerequisite for the DRP indication.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 05, 2021
Details:
Company received a notification from the U.S. FDA, stating that, Company’s supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 08, 2021
Details:
FDA has pointed deficiencies that preclude discussion of labeling and post-marketing requirements/commitments of Pimavanserin at this time. NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 08, 2021
Details:
Treatment with pimavanserin (Nuplazid; Acadia Pharmaceuticals) produced a robust reduction in psychosis symptoms, irrespective of most likely clinical diagnosis of dementia subtype or baseline dementia severity.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 29, 2020
Details:
The sNDA is supported by results from the pivotal Phase 3 HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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:
The study did not achieve statistical significance on the primary endpoint which was the 17-item Hamilton Depression Rating Scale (HAMD-17) total score change from baseline to week 5.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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:
Nuplazid (pimavanserin) is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors, which is used treatment for Hallucinations and Delusions Associated with Dementia-Related Psychosis.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid
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 15, 2020
Details:
CLARITY-2 and CLARITY-3 are both 6-week, parallel-designed, randomized, double-blind, placebo-controlled, multi-center studies designed to evaluate the efficacy and safety of pimavanserin as adjunctive treatment in patients with MDD.
Lead Product(s): Pimavanserin Tartrate
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 26, 2020
Details:
Multiple scientific presentations and abstracts evaluating pimavanserin in clinical studies for the treatment of various central nervous system (CNS) disorders will be highlighted at the 2020 American Society of Clinical Psychopharmacology (ASCP) Virtual Annual Meeting.
Lead Product(s): Pimavanserin Tartrate
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
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 21, 2020
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