Drug intelligence / Profile preview

ZR-02-01

Development stage
Phase 2
Lead developer
Apotex
Modality
Transdermal Patches → Device-based Delivery → Drug Delivery Systems, Small Molecules
Administration
Transdermal
01

Overview

ZR-02-01 is an investigational transdermal matrix patch formulation of the potent synthetic opioid analgesic fentanyl, developed to provide sustained systemic fentanyl delivery for the management of chronic moderate to severe pain, including cancer pain, osteoarthritis pain, and other non-malignant chronic pain conditions.[1][7][8][12][13][15] The product uses a matrix patch technology designed by ZARS Pharma/ZARS to deliver fentanyl continuously through the skin over an extended period, aiming to offer consistent analgesia with a potentially differentiated pharmacokinetic profile compared with existing fentanyl patches.[1][7][11][12] Multiple phase 2 and phase 3 clinical trials evaluated its safety, tolerability, pharmacokinetics, and analgesic efficacy, but pharmacokinetic data indicated that the product did not meet requirements for further development, and clinical programs were ultimately terminated without approval.[12][9]

Other names
fentanyl transdermal matrix patch ZR-02-01matrix fentanyl patch ZR-02-01
02

Targets

MOR (Mu opioid receptor)

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