Drug intelligence / Profile preview

AP09004

Development stage
Phase 4
Lead developer
Indaptus Therapeutics
Modality
Small Molecules
Administration
Oral
01

Overview

AP09004, also called **AP-CD/LD**, is an investigational oral, gastric-retentive dual-release fixed-dose formulation of **carbidopa + levodopa** developed by Intec Pharma using its Accordion Pill platform. The capsule contains a folded biodegradable polymeric film system intended to remain in the stomach and provide immediate and controlled release of carbidopa and levodopa, with the goal of smoothing levodopa exposure and reducing motor fluctuations and OFF time in Parkinson's disease. Carbidopa inhibits peripheral aromatic L-amino acid decarboxylase, increasing levodopa availability to the brain, where levodopa is converted to dopamine. AP-CD/LD reached Phase 3 in advanced Parkinson's disease, but the pivotal ACCORDANCE study did not demonstrate statistically significant superiority over immediate-release carbidopa/levodopa for reduction in daily OFF time. ([clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00918177))

Brand names
Accordion Pill Carbidopa/Levodopa
Other names
Accordion Pill Carbidopa/Levodopa
02

Targets

DDC (Aromatic L-amino acid decarboxylase)DRD (Dopamine receptors)

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