Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD1722 · 9 trials · 10 indications
Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment
Weekly complete spontaneous bowel movement resaponders defined as an increase of one or more bowel movement per week from baseline for 6 of the 12 weeks
The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment
Patients are weighed pre dialysis prior to their first dialysis of the week. This measure looks at the change in pre-dialysis weight over time
Change in plasma area under the concentration-time curve (AUC) and maximal plasma concentration (Cmax) of midazolam after AZD1722 administration
Measurement of safety laboratories, ECGs, vital signs, and physical exams
Pharmacodynamic activity
| Arm | Type | Description |
|---|---|---|
| 1 mg bid | EXPERIMENTAL | 1 mg AZD1722 bid |
| 3 mg bid | EXPERIMENTAL | 3 mg AZD1722 bid |
| 10 mg bid | EXPERIMENTAL | 10 mg AZD1722 bid |
| 30 mg bid | EXPERIMENTAL | 30 mg AZD1722 bid |
| 3 mg od | EXPERIMENTAL | 3 mg AZD1722 od |
| 30 mg od | EXPERIMENTAL | 30 mg AZD1722 od |
| Placebo | PLACEBO_COMPARATOR | Placebo (double dummy technique) |
| 5 mg BID | EXPERIMENTAL | AZD1722 |
| 20 mg BID | EXPERIMENTAL | AZD1722 |
| 50 mg BID | EXPERIMENTAL | AZD1722 |
| AZD1722 | ACTIVE_COMPARATOR | AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks |
| AZD1722- in patient | EXPERIMENTAL | Tenapanor administered in a clinical pharmacology unit |
| Placebo- in patient | PLACEBO_COMPARATOR | Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit |
| AZD1722 out-patient | EXPERIMENTAL | Tenapanor |
| Placebo out-patient | EXPERIMENTAL | Placebo |
| Midazolam 7.5 mg | ACTIVE_COMPARATOR | Volunteers will receive Midazolam 7.5 mg administered by mouth as a syrup |
| AZD1722 15 mg | EXPERIMENTAL | Volunteers will received AZD1722 15 mg administered by mouth, as a tablet |
| AZD1722 15 mg and Midazolam 7.5 mg | EXPERIMENTAL | Volunteers will receive AZD1722 15 mg tablet and Midazolam 7.5 mg syrup, by mouth |
| AZD1722 alone | EXPERIMENTAL | 15 mg BID |
| AD1722 with Renvela | EXPERIMENTAL | AZD1722 15 mg BID and Renvela 800 mg TID |
| AZD1722 HCl Capsule | EXPERIMENTAL | 15 mg bid AZD1722 HCl and 20 mg bid Omeprazole |
| AZD1722 HCl Tablet | EXPERIMENTAL | 15 mg bid AZD1722 HCl and 20 mg bid Omeprazole |
| AZD1722 Free-base Tablet | EXPERIMENTAL | 15 mg bid AZD1722 and 20 mg bid Omeprazole |
| Name | Type | Description |
|---|---|---|
| AZD1722 | DRUG | AZD1722, oral tablet |
| Placebo | DRUG | Placebo bid, double dummy technique |
| AZD1722 (in-patient) | DRUG | doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting |
| Placebo (in-patient) | DRUG | Placebo, size and color matched to experimental drug administered in a CPU |
| AZD1722 (out-patient) | DRUG | doses between 5 and 45 mg BID |
| Midazolam | DRUG | Volunteers will receive a single dose of Midazolam 7.5 mg on Day 1 |
| AZD1722 and Midazolam | DRUG | On Day 15 volunteers will receive AZD1722 15 mg and Midazolam 7.5 mg at the same time in the morning. In the evening on Day 15 AZD1722 15 mg will be administered alone. |
| Renvela | DRUG | - |
| Omeprazole | DRUG | - |
Inclusion Criteria: 1. Females and males aged ≥18 years 2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months 3. Prescribed and taking at least 3 doses of phosphate binder per day 4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) ...
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AZD1722 is an investigational small molecule being studied for conditions including hyperphosphatemia, constipation predominant irritable bowel syndrome, chronic kidney disease, and end stage renal disease. It has been evaluated in Phase 2 trials for end stage renal disease patients on hemodialysis and for chronic kidney disease patients with type 2 diabetes mellitus and albuminuria.
AZD1722 is being developed by Ardelyx, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ARDX. The drug is a small molecule in the metabolic therapeutic area and is currently in clinical development.
AZD1722 is in Phase 2 clinical development. Two Phase 2 trials have been completed, along with two Phase 1 trials. The drug is investigational and has not been approved by the FDA.
AZD1722 has been studied in four completed trials. NCT01764854 was a Phase 2 pharmacodynamic study in end stage renal disease patients on hemodialysis. NCT01847092 was a Phase 2 study in chronic kidney disease patients with type 2 diabetes mellitus and albuminuria. NCT02063386 and NCT02140268 were Phase 1 studies in healthy volunteers.
AZD1722 is a small molecule being developed for metabolic conditions. Its specific molecular target has not been disclosed in the available clinical trial information.
AZD1722 is not listed as an alternative name for tenapanor in the available information. The drug is identified solely as AZD1722 in its clinical trial records.