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Also known as CID 177236, LU-135252, HMR-4005
darusentan · 4 trials · 3 indications
Markovian homogeneity analysis characterizes an image produced by a PET scan by examining the probability that a pixel with a given intensity will have a neighbor with a different intensity. The homogeneity index ranges from \>0 to 1, where a value near 0 represents an image with a high probability that neighboring pixels have intensity values that differ greatly, and a value near 1 represents an image with a high probability that neighboring pixels have similar intensity values.
| Arm | Type | Description |
|---|---|---|
| Darusentan | EXPERIMENTAL | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan capsules titrated to an optimal dose of 50 mg, 100 mg, or 300 mg administered orally once daily for 14 weeks |
| Guanfacine | ACTIVE_COMPARATOR | Placebo to match darusentan for 2-week placebo run-in period, followed by guanfacine 1 mg capsules administered orally once daily for 14 weeks |
| Darusentan Placebo | PLACEBO_COMPARATOR | Placebo to match darusentan for 2-week placebo run-in period, followed by placebo to match darusentan administered orally once daily for 14 weeks |
| Darusentan 50 mg | EXPERIMENTAL | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 50 mg administered orally once daily for 14 weeks |
| Darusentan 100 mg | EXPERIMENTAL | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 100 mg administered orally once daily for 14 weeks |
| Darusentan 300 mg | EXPERIMENTAL | Placebo to match darusentan for 2-week placebo run-in period, followed by darusentan 300 mg administered orally once daily for 14 weeks |
| Group 1 | ACTIVE_COMPARATOR | Group 1 will receive oral darusentan 100mg for 2 weeks during Phase 1 then placebo for 2 weeks during Phase 2. |
| Group 2 | ACTIVE_COMPARATOR | Group 2 will receive placebo for 2 weeks during Phase 1 then oral darusentan 100 mg for two weeks during Phase 2 |
| Name | Type | Description |
|---|---|---|
| Darusentan | DRUG | Darusentan capsules administered orally once daily |
| Guanfacine | DRUG | Guanfacine capsules administered orally once daily |
| Darusentan Placebo | DRUG | Placebo to match darusentan administered orally once daily |
| darusentan 100 mg | DRUG | All subjects will receive oral darusentan 100 mg for a total of 2 weeks and placebo for 2 weeks. |
SELECTED INCLUSION CRITERIA: 1. Subjects who are competent to provide written consent; 2. Aged 35 to 80 years; 3. Subjects with diabetes and/or chronic kidney disease must have an average sitting systolic blood pressure greater than or equal to 130 mmHg; 4. All other subjects must have an average s...
Top 9 of 16 competitors
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| AstraZeneca PLC | AZN | 5 | PHASE3 | Baxdrostat |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Clazakizumab |
| Alnylam Pharmaceuticals, Inc | ALNY | 2 | PHASE3 | Zilebesiran, ALN-AGT01 RVR |
| Mineralys Therapeutics, Inc. | MLYS | 1 | PHASE3 | lorundrostat |
| United Therapeutics Corporation | UTHR | 1 | PHASE3 | Ralinepag |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE2 | QCZ484, HJB647 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | iloperidone |
| Opus Genetics, Inc. | IRD | 1 | PHASE1 | OPGx-BEST1 |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX340 |
Darusentan is an investigational small molecule developed by Gilead Sciences, Inc. (ticker GILD) for cardiovascular conditions. It has been studied in coronary artery disease and hypertension, including resistant hypertension. Darusentan is not approved and remains in clinical development, with Phase 2 listed as its current stage.
Darusentan has been studied for hypertension, particularly resistant hypertension in patients receiving multiple blood pressure lowering drugs. Trials such as DORADO and DORADO-AC evaluated it in this setting. It is investigational and has not been approved for any use.
Darusentan targets the endothelin receptors EDNRA and EDNRB as an antagonist. By blocking these receptors, it inhibits endothelin-mediated signaling, which is relevant to vascular tone and blood pressure regulation. This mechanism underlies its study in hypertension and coronary artery disease.
Darusentan is developed by Gilead Sciences, Inc., which trades under the ticker GILD. The company sponsored the clinical trials evaluating darusentan in hypertension and coronary artery disease.
Darusentan is in Phase 2 development according to its current stage. It is investigational and has not been approved by the FDA. Completed trials include Phase 2 and Phase 3 studies, but no active trials are ongoing.
Darusentan has been evaluated in completed trials including NCT00738049 (Phase 2, coronary artery disease and endothelial dysfunction), NCT00389779 (Phase 3, resistant hypertension), NCT00364026 (Phase 2, resistant systolic hypertension), and NCT00330369 (Phase 3, resistant hypertension). All trials are completed and no active trials are listed.