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news.The Interim data analysis of Nektar Therapeutics' analgesic drug NKTR-181 showed long-acting pharamcokinetic profile (PK) with analgesic response and safety profile, according to Phase 1 clinical trial.
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NKTR-181, a mu-opioid analgesic investigational drug candidate, was created using Nektar’s small molecule polymer conjugate technology.
The Phase 1 study is assessing the pharmacokinetics, pharmacology, safety and efficacy of single doses of NKTR-181 in approximately 125 healthy subjects.
The primary objective of the Phase 1 trial is to establish the effective analgesic dose range of NKTR-181 associated with minimal CNS side effects.
The PK data from the Phase 1 study showed that single doses of NKTR-181 achieved a dose-linear PK profile and the plasma half-life is greater than 10 hours across all five dose cohorts tested to-date, which includes 75 healthy subjects.
NKTR-181 also displayed good oral bioavailability with rapid absorption, and its plasma half-life supports its potential to be dosed on a once-daily or twice-daily schedule.
Additional interim data from the study show that NKTR-181 exhibits pharmacological activity in humans.
The study is being conducted in the US and is currently ongoing.
Nektar has an exclusive worldwide license agreement with AstraZeneca for its oral NKTR-118 program to treat opioid-induced constipation.