[Translation] A randomized, double-blind, parallel, placebo-controlled phase II study of the efficacy and safety of TUL01101 ointment in adult patients with mild to moderate atopic dermatitis

主要目的：评估不同浓度和不同给药频率的TUL01101软膏在轻中度特应性皮炎成年患者中的有效性。次要目的：评估不同浓度和不同给药频率的TUL01101软膏在轻中度特应性皮炎成年患者中的安全性和药代动力学特征。

[Translation]

Primary objective: To evaluate the effectiveness of TUL01101 ointment at different concentrations and dosing frequencies in adult patients with mild to moderate atopic dermatitis. Secondary objective: To evaluate the safety and pharmacokinetic characteristics of TUL01101 ointment at different concentrations and dosing frequencies in adult patients with mild to moderate atopic dermatitis.

Start Date20 May 2024

Sponsor / Collaborator

Zhuhai United Laboratories Holding Ltd.

CTR20233576 / RecruitingPhase 2

TUL01101片在中重度特应性皮炎成年患者中的有效性和安全性的随机、双盲、平行、安慰剂对照Ⅱ期研究

[Translation] A randomized, double-blind, parallel, placebo-controlled phase II study on the efficacy and safety of TUL01101 tablets in adult patients with moderate to severe atopic dermatitis

主要目的：评估不同剂量的TUL01101片在中重度特应性皮炎成年患者中的有效性。次要目的：评估不同剂量的TUL01101片在中重度特应性皮炎成年患者中的安全性和耐受性；评估TUL01101片在中重度特应性皮炎成年患者中的药代动力学特征。

[Translation]

Primary objective: To evaluate the efficacy of different doses of TUL01101 tablets in adult patients with moderate to severe atopic dermatitis. Secondary objective: To evaluate the safety and tolerability of different doses of TUL01101 tablets in adult patients with moderate to severe atopic dermatitis; to evaluate the pharmacokinetic characteristics of TUL01101 tablets in adult patients with moderate to severe atopic dermatitis.

Start Date03 Jan 2024

Sponsor / Collaborator

Zhuhai United Laboratories Holding Ltd.

ChiCTR2300070742 / RecruitingPhase 1IIT

A Phase I clinical trial evaluating the drug-drug interaction and safety of TUL01101 tablets versus Methotrexate tablets in patients with rheumatoid arthritis

Start Date22 Apr 2023

Sponsor / Collaborator-

100 Clinical Results associated with TUL01101

100 Translational Medicine associated with TUL01101

100 Patents (Medical) associated with TUL01101

Literatures (Medical) associated with TUL01101

22 Dec 2022·Journal of Medicinal ChemistryQ1 · MEDICINE

Identification of TUL01101: A Novel Potent and Selective JAK1 Inhibitor for the Treatment of Rheumatoid Arthritis

Q1 · MEDICINE

Article

Author: Zhou, Shuhao ; Mao, Weiwei ; Qian, Wenyuan ; Shen, Meiyue ; Su, Yuan ; Mu, Liwei ; Wang, Degang ; Sun, Tiemin ; Zheng, Xuejian ; Wu, Shouting ; Li, Yaoshuang ; Shan, Ningli

Janus kinase 1 (JAK1) is a potential target for the treatment of rheumatoid arthritis (RA). In this study, the introduction of a spiro ring with a difluoro-substituted cyclopropionamide resulted in the identification of TUL01101 (compound 36) based on a triazolo[1,5-a]pyridine core of filgotinib. It showed excellent potency on JAK1 with an IC₅₀ value of 3 nM and exhibited more than 12-fold selectivity for JAK2 and TYK2. Whole blood assay also demonstrated the high activity and selectivity (37-fold for JAK2). At the same time, TUL01101 also demonstrated excellent metabolic stability and pharmacokinetics (PK) profiles were assayed in three species (mouse, rat, and dog). Moreover, it has been validated for effective activity in the treatment of RA both in collagen-induced arthritis (CIA) and adjuvant-induced arthritis (AIA) models, with low dose and low toxicity. Now, TUL01101 has progressed into phase I clinical trials.

100 Deals associated with TUL01101

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mild Atopic Dermatitis	Phase 2	CN	Zhuhai United Laboratories Holding Ltd.	20 May 2024
Moderate Atopic Dermatitis	Phase 2	CN	Zhuhai United Laboratories Holding Ltd.	03 Jan 2024
Severe Atopic Dermatitis	Phase 2	CN	Zhuhai United Laboratories Holding Ltd.	03 Jan 2024
Rheumatoid Arthritis	Phase 1	CN	Zhuhai United Laboratories Holding Ltd.	20 Oct 2020

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