Last update 06 Sep 2025

FZ-016

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
SKL PSY, SKL-PSY/FZ-016
Target
5-HT1A receptor
Action
modulators
Mechanism
5-HT1A receptor modulators(Serotonin 1a (5-HT1a) receptor modulators)
Therapeutic Areas
Nervous System Diseases
Active Indication
Bipolar Disorder
Inactive Indication
Anxiety DisordersDepressive Disorder
Originator Organization
SK Biopharmaceuticals Co., Ltd.SK Biopharmaceuticals Co., Ltd.
Active Organization
PKU International Healthcare Group Co., Ltd.PKU International Healthcare Group Co., Ltd.SK Biopharmaceuticals Co., Ltd.SK Biopharmaceuticals Co., Ltd.Shanghai Medicilon, Inc.Shanghai Medicilon, Inc.
Inactive Organization
Pkucare Pharmaceutical R&D CenterPkucare Pharmaceutical R&D Center
License Organization
SK Biopharmaceuticals Co., Ltd.SK Biopharmaceuticals Co., Ltd.Shanghai Medicilon, Inc.Shanghai Medicilon, Inc.
Drug Highest PhasePhase 1
First Approval Date-
RegulationSpecial Review Project (China)
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Related

1
Clinical Trials associated with FZ-016
CTR20191556
/ RecruitingPhase 1
中国健康受试者单次口服FZ016胶囊的随机、双盲、安慰剂对照、剂量递增的耐受性及药代动力学研究
[Translation] A randomized, double-blind, placebo-controlled, dose-escalation study of the tolerability and pharmacokinetic efficacy of a single oral dose of FZ016 capsules in healthy Chinese subjects
100 Clinical Results associated with FZ-016
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100 Translational Medicine associated with FZ-016
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100 Patents (Medical) associated with FZ-016
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100 Deals associated with FZ-016
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Depressive DisorderPhase 1
China
Pkucare Pharmaceutical R&D CenterPkucare Pharmaceutical R&D Center
02 Aug 2019
Bipolar DisorderPhase 1
United States
--
Bipolar DisorderPhase 1
China
Shanghai Medicilon, Inc.Shanghai Medicilon, Inc.
-
Bipolar DisorderPhase 1
China
PKU International Healthcare Group Co., Ltd.PKU International Healthcare Group Co., Ltd.
-
Bipolar DisorderPhase 1-
SK Biopharmaceuticals Co., Ltd.SK Biopharmaceuticals Co., Ltd.
-
Anxiety DisordersPreclinical
South Korea
SK Biopharmaceuticals Co., Ltd.SK Biopharmaceuticals Co., Ltd.
-
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Clinical Result

Indication
Phase
Evaluation
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Clinical Trial

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Approval

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Regulation

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