Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Over-encapsulated amlodipine · 1 trial · 1 indication
Including any untoward medical occurrence in a participant administered study drug, which do not necessarily have a causal relationship with the study drug \[i.e., any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug\].
| Arm | Type | Description |
|---|---|---|
| Amlodipine+Celecoxib | EXPERIMENTAL | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks |
| Amlodipine+Placebo | ACTIVE_COMPARATOR | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
| Placebo+Celecoxib | PLACEBO_COMPARATOR | Matched placebo capsule for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks |
| Placebo+Placebo | SHAM_COMPARATOR | Matched placebo capsule for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
| Name | Type | Description |
|---|---|---|
| Over-encapsulated 10 mg amlodipine besylate tablet | DRUG | Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks |
| Matched placebo capsule for over-encapsulated celecoxib capsule | DRUG | Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
| Over-encapsulated 200 mg celecoxib capsule | DRUG | Over-encapsulated 200 mg celecoxib capsule once a day for two weeks |
| Matched placebo capsule for over-encapsulated amlodipine besylate tablet | DRUG | Matched placebo capsule for over-encapsulated amlodipine besylate tablet once a day for two weeks |
Inclusion Criteria: 1. Adult 40 to 75 years of age 2. Newly diagnosed hypertension that requires chronic pharmacological therapy. Specifically, the subject must meet both of the following criteria: 1. Resting systolic BP ≥140 mmHg and ≤179 mmHg (where resting is defined as supine for at least 1...
Top 9 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| 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 |
Over-encapsulated amlodipine is an investigational formulation of amlodipine besylate, a small molecule antihypertensive, in which the 10 mg tablet is placed inside a capsule. It is being developed by Purple Biotech Ltd. (ticker PPBT) for hypertension and has completed a Phase 3 trial.
Over-encapsulated amlodipine is being studied for hypertension, also known as high blood pressure. The Phase 3 trial enrolled adults with hypertension requiring antihypertensive therapy. It is an investigational product and is not described as approved for any use.
Over-encapsulated amlodipine is developed by Purple Biotech Ltd., which trades under the ticker PPBT. The company sponsored the Phase 3 hypertension study of the over-encapsulated 10 mg amlodipine besylate tablet.
Over-encapsulated amlodipine has reached Phase 3. One Phase 3 trial has been completed, and no trials are currently listed as active. The program remains in clinical development and is not described as approved.
Over-encapsulated amlodipine has been studied in one completed Phase 3 trial, NCT02172040, titled a study to evaluate the effect of celecoxib on the efficacy and safety of amlodipine in subjects with hypertension requiring antihypertensive therapy. It was randomized, double blind, placebo controlled, enrolled 152 participants, and ran in the United Kingdom.