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Pimavanserin tartrate

CAS No.

389574-19-0

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 with PIPELINE & EARLY DEVELOPMENT STATUS under patent (SPC) protection in Poland and/or other countries are not offered until expiration of the corresponding IP right.
Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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