Available EU DMF/CEP
EU DMF
CEP
API Status
Commercial
Pipeline
Therapeutic Category
Alimentary tract & metabolism
Anti-infectives for systemic use
Antipyretic, analgesic and anti-inflammatory
Antineoplastic & immunomodulating agents
Blood & blood forming organs
Cardiovascular system
Genito-urinary system & sex hormones
Injectable forms
Musculo-skeletal system
Nervous system
Opthalmological preparations
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Available US DMF
US DMF
Available Japanese/Chinese DMF
Japanese DMF
Chinese DMF
Korean DMF

Pimavanserin tartrate

CAS No.

706782-28-7 (tartrate)

Reference product

Nuplazid/acadia

Polymorphic form

Crystalline anhydrous form C

Therapeutic Area

Nervous system

Status

Pipeline

EU DMF readiness

US DMF readiness

033385

Polpharma API characteristics:

  • Crystalline Form C, same as in innovator’s tablets (physico-chemically most stable)
  • PSD tailored to FDF needs
  • Good control of Impurity profile by handling 4 chemical steps in-house (2 isolated intermediates)
  • Green chemistry - no phosgenation reactions

Drug description:

Pimavanserin tartrate acts as anti-psychotic agent.
Pimavanserin is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
It is also under development for the treatment of hallucinations and delusions associated with dementia-related psychosis, psychosis in schizophrenia patients, Alzheimer’s disease agitation, Alzheimer’s disease psychosis (ADP), Dementia with Lewy bodies, Parkinson’s disease dementia, Vascular dementia, Frontotemporal dementia, as adjunctive treatment for the negative symptoms of Schizophrenia and Major Depressive Disorder.
It is formulated as film coated tablets for an oral route of administration.

Mechanism of action:

Pimavanserin selectively blocks the activity of the 5-HT2A receptor, a drug target that plays an important role in the treatment of various neuropsychiatric disorders. It works on the neurotransmitter serotonin, by binding with the 5-HT2A receptor.

DISCLAIMER
The above product is presented solely for informational purposes and does not constitute an offer in any sense. Products under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.

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