Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MK-8226 · 1 trial · 1 indication
Assessment of the number of participants with at least one clinical or laboratory AE in those receiving multiple oral doses of MK-8266. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product.
Assessment of the number of participants receiving MK-8266 who discontinued therapy due to an AE over 10 days of treatment. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. The number of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Days 0-10.
Assessment of the change from baseline in SBP, obtained using a validated, semi-automated oscillometric device. Evaluated for MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA\^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis.
Assessment of HR (beats/min) on Day 10 (24-hours postdose) with MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA\^0-24hrs). Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Baseline HR values are shown in the Baseline Characteristics section for Panels A, B, C, D, E.
| Arm | Type | Description |
|---|---|---|
| Panel A: MK-8266 BID, 1 mg/Placebo | EXPERIMENTAL | MK-8266 1 mg (0.7 mg in the morning \[AM\] + 0.3 mg in the evening \[PM\]), or as matching placebo BID. |
| Panel B: MK-8266 BID, 1.8 mg/Placebo | EXPERIMENTAL | MK-8266 1.8 mg (1 mg in the AM + 0.8 mg in the PM), or as matching placebo BID. |
| Panel C: MK-8266 TID, 1.8 mg/Placebo | EXPERIMENTAL | MK-8266 TID, 1.8 mg (0.6 mg every 6 hours \[q6hr\]), or as matching placebo TID. |
| Panel D: MK-8266 TID, 2.4 mg/Placebo | EXPERIMENTAL | MK-8266 TID (Panel D), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel D was completed prior to initiation of Panel E. |
| Panel E: MK-8266 TID, 2.4 mg/Placebo | EXPERIMENTAL | MK-8266 TID (Panel E), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel E was initiated after completion of Panel D. |
| Name | Type | Description |
|---|---|---|
| MK-8226 BID, 1 mg | DRUG | MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B. |
| MK-8266 BID, 1.8 mg | DRUG | MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C. |
| MK-8266 TID, 1.8 mg | DRUG | MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D. |
| MK-8266 TID, 2.4 mg | DRUG | MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E. |
| Placebo BID (Panel A) | DRUG | Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B. |
| Placebo BID (Panel B) | DRUG | Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C. |
| Placebo TID (Panel C) | DRUG | Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D. |
| Placebo TID (Panel D) | DRUG | Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E. |
| Placebo TID (Panel E) | DRUG | Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D. |
Inclusion Criteria: * Participant is male with essential hypertension (high blood pressure) * Participant is in good general health (with the exception of hypertension) * Participant has a Body Mass Index (BMI) \<= 33 kg/m\^2 at the Screening visit * Participant has a platelet count \>= 150,000 cu/...
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 |
MK-8226 is an investigational small molecule being studied for the treatment of hypertension, a cardiovascular condition. It has been evaluated in a Phase 1 clinical trial in hypertensive men. MK-8226 is not approved for any indication and remains in clinical development.
MK-8226 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The compound is an investigational small molecule in the company's cardiovascular pipeline, studied for hypertension.
MK-8226 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study enrolled 40 participants and was randomized, double-blind, and controlled. MK-8226 is investigational and has not been approved for marketing.
MK-8226 has been studied in one completed Phase 1 trial, NCT01096160, titled a study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-8266 in hypertensive men. The trial enrolled 40 male participants aged 18 years and older, was randomized, double-blind, and controlled, and did not include healthy volunteers.