Drug name: Runcaciguat (BAY 1101042)
CAS: 1402936-61-1
Indications: Chronic Kidney Disease (NCT04507061), Non-Proliferative Diabetic Retinopathy (NCT04722991)
Development Phase: Phase II
Current clinical study NCT04722991 code.
Data from the NCT04507061 portion of the trial were released on November 5, 2022. In all four rat CKD models, runcaciguat significantly and dose-dependently decreased proteinuria by 40%–55%. In ZDF rats, long-term treatment for 42 weeks led to reductions in glomerular filtration rate and improvements in fibrosis, protein casts, tubular degeneration, and glomerular disease.
There was a statistically significant difference between 3mg /kg bid compared to placebo
Drug name: Zabedosertib (BAY 1834845）
CAS:1931994-81-8
Indication: Atopic dermatitis (NCT04417036)
Development Phase: Phase II
The primary goal of this investigation (NCT04417036) is to assess the efficacy of zabedosertib against a placebo. After 12 weeks of treatment, researchers will evaluate the proportions of people who received zabedosertib vs placebo who saw a 75% decrease in their EASI score.Eczema Area and Severity Index (EASI) is a name for the condition. It is a tool used to gauge a patient's level of atopic dermatitis and its severity. The range of the scale is 0-72, with 0 denoting healthy skin and 72 denoting severe atopic dermatitis. Additionally, the pruritus levels and other indicators of atopic dermatitis severity will be evaluated in research participants.
This study's second goal is to evaluate its safety in comparison to a placebo. The research team will compare the proportion of participants treated with zabedosertib and placebo who experienced an adverse event after receiving the study treatment in order to better understand this.
Participants in this trial will be assigned at random (by chance) to receive either zabedosertib or a placebo. For up to 12 weeks, participants in both treatment groups will either take zabedosertib or a placebo.
The study consists of a screening phase lasting up to 28 days (visits 1 and 2), a treatment phase lasting 12 weeks and requiring 5 visits (visits 3–7), and a follow-up phase lasting 4 weeks (visit 8). Therefore, each participant's entire research time was between 17 and 20 weeks, or roughly 140 days.
Drug name: Elinzanetant
CAS: 929046-33-3
Indication: vasodilatory symptoms (NCT05042362 NCT05099159 NCT05030584 NCT05587296 )
Development phase: Phase III
Elinzanetant was purchased by Bayer in September 2020 from the UK business KaNDy Therapeutics Ltd. This allowed Bayer to completely include elinzanetant into its development pipeline for women's healthcare. In order to evaluate the effectiveness and safety of elinzanetant (120 mg once day) in breast cancer patients with vasodilatory symptoms brought on by endocrine therapy as well as in women at high risk for breast cancer, the Phase III OASIS 4 trial program involved 400 patients from 95 medical sites across 15 countries. In order to assess the effectiveness and safety of elinzanetant (120 mg once daily) for the treatment of vasodilatory symptoms in menopausal women, Bayer began the Phase III OASIS research in August 2021. Positive results from two Phase II trials (RELENT-1 and SWITCH-1) served as the foundation for the Phase III study's design and dose. Elinzanetant's safety, pharmacokinetics, and potential efficacy are being studied in the Phase Ib/IIa trial RELENT-1. In the Phase IIb study SWITCH-1, patients with vasodilatory symptoms were compared to the efficacy and safety of four different dosages of elinzanetant vs a placebo. Vasodilatory symptoms can significantly affect the quality of life and treatment sustainability for breast cancer patients who have been receiving endocrine therapy for a long time, which in turn affects the effectiveness of their cancer treatment and survival, according to Dr. Christian Rommel, member of the Bayer Division's Executive Committee and Head of Global Research and Development.We are enhancing the quality of life for patients who are experiencing vasodilatory symptoms brought on by endocrine therapy by including the OASIS 4 trial into our Phase III program.
Reference:
1.Runcaciguat, a Novel Soluble Guanylate Cyclase (sGC) Activator, Shows Kidney Protection in Models of CKD
2.WO2019105881
3.WO2017186703
4.clinicaltrials.bayer
5.WO2021094247
6.Bayer initiates a phase III clinical trial of the world's first NK1/3R antagonist for the treatment of endocrine therapy-induced hot flashes in breast cancer
7.Bayer official website
