Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CIN-107 dosing · 1 trial · 2 indications
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period.
The mean seated SBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean seated SBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
| Arm | Type | Description |
|---|---|---|
| CIN-107 for dosing at 2, 4, or 8 mg (QD) | EXPERIMENTAL | Patients will be provided with an initial dose of CIN-107 and start once daily (QD) dosing of CIN-107 tablets at 2 mg. At Visit 4, CIN-107 dose may be up-titrated to 4 mg QD if the patient has tolerated dosing of CIN-107 at 2 mg and the blood pressure (BP) records indicate minimal hypotension risk. At Visit 5, CIN-107 dose may be up-titrated to 8 mg QD if the patient has tolerated dosing of CIN-107 at 4 mg. |
| Name | Type | Description |
|---|---|---|
| CIN-107 2 mg dosing | DRUG | One tablet of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 2 mg. |
| CIN-107 4 mg dosing | DRUG | Two tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 4 mg. |
| CIN-107 8 mg dosing | DRUG | Four tablets of CIN-107 2 mg tablets, once daily, by mouth, for dosing at 8 mg. |
Inclusion Criteria: 1. Have been diagnosed with PA. 2. Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly diagnosed with PA and have not started MRA treatment. 3. Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA. 4. Are willing to ...
CIN-107 is an investigational small molecule being studied for the treatment of primary aldosteronism, a condition in which the adrenal glands produce too much aldosterone. It is being developed by AstraZeneca PLC under the ticker AZN. The drug has been evaluated in a Phase 2 clinical trial in adults with primary aldosteronism.
CIN-107 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating CIN-107 in primary aldosteronism.
CIN-107 is in Phase 2 clinical development. It has completed one Phase 2 trial in adults with primary aldosteronism. The drug is investigational and has not been approved by the FDA for any indication.
CIN-107 has been studied in one completed Phase 2 trial, NCT04605549, titled A Study of CIN-107 in Adults With Primary Aldosteronism. The trial enrolled 15 adults aged 18 years and older in the United States and included participants with primary aldosteronism or hyperaldosteronism.