Developer · 4151 · Japan

Kyowa Kirin Co., Ltd.

Tokyo-headquartered global specialty pharmaceutical company (TSE: 4151), a member of the Kirin Group, focused on nephrology, oncology, immunology/allergy and the central nervous system. In CNS it discovered and markets istradefylline (NOURIANZ in the US, NOURIAST in Japan), the first adenosine A2A receptor antagonist approved for Parkinson's disease, and developed the follow-on A2A antagonist/inverse agonist KW-6356 (sipagladenant) through Phase 2 before discontinuing it in July 2022.

kyowakirin.com ↗

1compound
1program
1indication
Discontinuedlead asset

Phase distribution

  • Discontinued1

Modality

  • Small molecule 1

Mechanism focus

Pipeline (1)

Catalysts · 0 upcoming · 2 reported

Recently reported

  • 2020-10-21met

    SipagladenantforParkinson's diseaseTopline data

    Positive Phase 2b topline: KW-6356 adjunct to levodopa met the primary endpoint in 502 Parkinson's disease patients — MDS-UPDRS Part III significantly improved (p=0.006 at 3 mg, p=0.049 at 6 mg QD) and daily OFF time decreased, with no major safety issues.

    source ↗

  • 2018-08-20met

    SipagladenantforParkinson's diseaseFull results

    KW-6356 monotherapy improved motor symptoms vs placebo in early untreated Parkinson's disease (Phase 2, n=175): results presented at IAPRD 2018 and later published in Parkinsonism & Related Disorders (2024).

    source ↗

Recent activity

  • Jul 15, 2022Phase changeSipagladenant·Parkinson's diseaseDiscontinuedKyowa Kirin announced discontinuation of the entire KW-6356 clinical development program, explicitly acknowledging the compound was 'potentially effective in relieving motor and non-motor symptoms both as monotherapy and in combination with levodopa-containing therapy' but citing 'a thorough evaluation of the global regulatory landscape, development hurdles, and timelines for potential market entry'. A strategic termination after positive Phase 2 data; no Phase 3 was started.source ↗
  • Oct 21, 2020ReadoutSipagladenant·Parkinson's diseasemetPositive Phase 2b topline: KW-6356 adjunct to levodopa met the primary endpoint in 502 Parkinson's disease patients — MDS-UPDRS Part III significantly improved (p=0.006 at 3 mg, p=0.049 at 6 mg QD) and daily OFF time decreased, with no major safety issues.source ↗
  • Sep 29, 2018Phase changeSipagladenant·Parkinson's diseasePhase 2Phase 2b study NCT03703570 started: multicenter, randomized, double-blind, placebo-controlled, 26-week study of KW-6356 3 mg and 6 mg once daily as adjunct to levodopa-containing therapy in 502 Parkinson's disease patients in Japan (primary endpoint: change from baseline in MDS-UPDRS Part III).source ↗
  • Aug 20, 2018ReadoutSipagladenant·Parkinson's diseasemetKW-6356 monotherapy improved motor symptoms vs placebo in early untreated Parkinson's disease (Phase 2, n=175): results presented at IAPRD 2018 and later published in Parkinsonism & Related Disorders (2024).source ↗
  • Sep 1, 2016Phase changeSipagladenant·Parkinson's diseasePhase 2Early Phase 2 monotherapy study NCT02939391 started in subjects with early untreated Parkinson's disease (Japan; n=175; multiple once-daily doses vs placebo). ClinicalTrials.gov gives the start date at month precision ('2016-09'); this entry is anchored to the first of the month.source ↗

Competitive landscape

Other companies developing against Kyowa Kirin Co., Ltd.'s targets or indications.