(Carbidopa-Levodopa Controlled-Release Tablets) is a bi-modal controlled release product using a proprietary high-load/high-flux osmotic delivery technology, indicated for treatment of the patients with Parkinson's disease at early stage. WD-1603 can provide more stable levodopa plasma concentration profile, comparing to these marketed oral products. WDP has completed a phase II clinical trial with very promising result. A phase III clinical study will be initiated this year. This product may slow disease progression.
(Carbidopa-Levodopa Controlled-Release Tablets for bedtime use) is a delayed-controlled release product using a proprietary high-load/high-flux osmotic delivery technology, indicated for preventing "Early Morning Off” in patients with Parkinson's disease. WD-1905 will be the first levodopa product for preventing "Early Morning Off" for PD patients. A PoC clinical trial has been conducted in healthy volunteers to show a very promising pharmacokinetic profile. A PoC PK/PD study with Parkinson disease patients is ongoing.
(Carbidopa-Levodopa Oral Controlled-Release Tablets), for treatment of the patients with Parkinson’s disease at late stage, is a drug-device combination product to provide prolonged therapeutic coverage for the APIs with their absorption window limited at the upper gastrointestinal tract. WD-1804 aims to providing steady levodopa concentration profile like that with DUOPA®, which is an effective, but invasive therapeutic product. WD-1804 will have competitive advantages on product stability, low genotoxicity impurity, and non-invasive administration. Pre-IND meeting has been conducted with FDA in USA. The IND application for phase I/II clinical trial will be submitted to FDA in this year.
(Carbidopa-Levodopa granules) is a rapid-dissolution product using a proprietary AcuSiS® technology, indicated for the intermittent treatment of “OFF” episodes in patients with Parkinson's disease. A phase I study has demonstrated an excellent quick onset result.
WDP has already submitted 65 patent applications, including 54 invention patent applications, and 11 utility patent applications. As of today, 23 invention patents and 11 utility patents have been granted. The granted patents cover all projects mentioned above.
The following graph shows WDP’s R&D pipeline and their progression:
