Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
odanacatib · 10 trials · 2 indications
Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Month 24.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
aBMD (g/cm\^2) was measured by dual-energy X-ray absorptiometry (DXA) at the lumbar spine and mean BMD measurements from at least 3 evaluable lumbar spine vertebrae (L1-L4) were used. If a vertebra was fractured at baseline or became fractured during the study, its BMD measurement was excluded from the analysis and the lumbar spine BMD was recalculated based on the three remaining vertebrae. aBMD data was centrally evaluated and all areal BMD measurements included a longitudinal BMD correction factor as determined by the quality control center. aBMD at the lumbar spine was assessed at the Screening visit (Baseline), Month 6, Month 12, and Month 24 for the repeated measures longitudinal Analysis of Covariates (ANCOVA) model, with percent change from baseline at Months 12 and 24 pre-specified to be reported as primary and secondary outcome measures, respectively.
An AE was 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 products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm.
An AE was 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 products, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The percentage of participants that discontinued study treatment (different from discontinuation of the study) due to an AE was reported for each treatment arm.
BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
BMD (g/cm2) data was measured by dual-energy X-ray absorptiometry (DXA) at lumbar spine vertebrae 1 through 4 (L1-L4) from anterior view at the Observation visit (up to 5 weeks before Treatment Period), Week 0 (start of Treatment Period) and Week 52 (end of Treatment Period) or at discontinuation. Baseline was defined as the average of the 2 values collected at the Observation visit and Week 0 visit. Percent change from baseline in BMD = (\[BMD at Week 52 visit\] - \[baseline BMD\] ÷ baseline BMD) × 100. Measurements were performed using the Hologic Quantitative Digital Radiography (QDR) Series densitometer, and by same machine and under same scan mode throughout the study period. BMD data was centrally judged.
An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
An AE was defined as any unfavorable and unintended change in the structure (sign), function (symptoms), or chemistry of the body (laboratory data) temporally associated with the use of the SPONSOR's products (including placebo), whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product was also an AE. The number of participants that discontinued study drug due to an AE was reported for each treatment arm. Participants may have discontinued study drug but continued on the trial.
Percentage change in lumbar spine BMD (relative to baseline) at 12 Months.
Percentage change in lumbar spine BMD (relative to baseline) at 24 Months.
Percentage change in lumbar spine BMD (relative to baseline) at 36 months
Percentage change from baseline in lumbar spine BMD at 60 months.
Percentage change from baseline in lumbar spine BMD at 120 Months.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug.
uNTx/Cr is a biomarker of bone resorption. Urine samples were obtained predose on Day 1 (Baseline) and at various timepoints up to 336 hr postdose on Day 22 (Week 4). Fold change from baseline in time weighted average (TWA) of uNTx/Cr on log scale was analyzed via a linear mixed effect model. All analyses were carried out on the log-fold scale and final results were reported on the original percent scale in WAI after back transformation. The conversion used was weighted average inhibition (WAI) = (1-exp \[mean\])\*100, where the mean was the least squares (LS) mean of log-transformed ratio (TWA/baseline) from the above model.
| Arm | Type | Description |
|---|---|---|
| Odanacatib 50 mg once weekly | EXPERIMENTAL | Participants will receive one Odanacatib 50 mg tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. |
| Placebo once weekly | PLACEBO_COMPARATOR | Participants will receive one Placebo tablet once weekly. In addition, they will receive a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources is approximately 1200 mg. |
| Odanacatib 50 mg | EXPERIMENTAL | Participants receive 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also receive 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg. |
| Placebo | PLACEBO_COMPARATOR | Participants receive matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also receive 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg. |
| Odanacatib 10 mg | EXPERIMENTAL | After an observation period of \~5 weeks, participants receive 10 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods. |
| Odanacatib 25 mg | EXPERIMENTAL | After an observation period of \~5 weeks, participants receive 25 mg odanacatib once weekly for 52 weeks. Participants also receive weekly supplementation with open-label 5600 IU vitamin D3 and 500 mg of open-label daily calcium supplement (if calcium \<1000 mg per day from dietary and other sources) throughout the observation and treatment periods. |
| Odanacatib 3 mg | EXPERIMENTAL | - |
| Panel A - Odanacatib | EXPERIMENTAL | Panel A - Healthy male subjects receiving Odanacatib |
| Panel A - Placebo | PLACEBO_COMPARATOR | Panel A - Healthy male subjects receiving placebo |
| Panel B - Odanacatib | EXPERIMENTAL | Panel B - Healthy female subjects receiving Odanacatib |
| Panel B - Placebo | PLACEBO_COMPARATOR | Panel B - Healthy female subjects receiving placebo |
| 1 | EXPERIMENTAL | MK0822 |
| 2 | PLACEBO_COMPARATOR | Placebo to MK0822 |
| A | EXPERIMENTAL | Panel A |
| B | EXPERIMENTAL | Panel B |
| C | EXPERIMENTAL | Panel C |
| D | EXPERIMENTAL | Panel D |
| Name | Type | Description |
|---|---|---|
| Odanacatib | DRUG | One 50 mg tablet once weekly |
| Placebo for Odanacatib | DRUG | One 50 mg tablet once weekly |
| Vitamin D3 | DIETARY_SUPPLEMENT | 5600 IU of open-label Vitamin D3 once weekly |
| Calcium carbonate | DIETARY_SUPPLEMENT | Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg |
| Placebo | DRUG | Matching placebo tablets to odanacatib taken orally once weekly for 24 months. |
| Calcium supplement | DRUG | Calcium supplement 500 mg tablet taken orally once daily (up to \~1200 mg total) for 24 months. |
| Calcium | DIETARY_SUPPLEMENT | Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg. |
| Comparator: Placebo | DRUG | Oral Placebo tablet administered once weekly for 4 consecutive weeks |
| Comparator: placebo to MK0822 | DRUG | Panel A: placebo to MK0822 tablets 25 mg once weekly for 3 weeks. Panel B: placebo to MK0822 tablets 50 mg once weekly for 3 weeks. Panel C: placebo to MK0822 tablets 100 mg once weekly for 3 weeks. Panel D: placebo to MK0822 tablets 5 mg once weekly for 3 weeks. Panel E: placebo to MK0822 tablets 100 mg once weekly for 6 weeks. |
| Comparator: odanacatib (Panel B) | DRUG | Panel B: Odanacatib tablets will be administered to male subjects in rising single doses of 5, 25 (fasting), 100, 25 (fed), or 600 mg over 5 treatment periods. Each subject will receive placebo to odanacatib in one or two of the 5 treatment periods. There will be at least 7 days between each treatment period. |
| Comparator: odanacatib (Panel C) | DRUG | Panel C: Odanacatib tablets will be administered to female subjects in rising single doses of 50 or 100 mg over 2 treatment periods. Half of the subjects will receive placebo to odanacatib in one of the 2 treatment periods. There will be at least 7 days between each treatment period. |
| Comparator: odanacatib (Panel D) | DRUG | Panel D: Odanacatib tablets or placebo to odancatib will be administered to male subjects in rising single doses of 100, 200, or 300 mg following a high-fat breakfast over 3 treatment periods. Three of twelve subjects will receive placebo to odanacatib in all 3 treatment periods. There will be at least 10 days between each treatment period. |
Inclusion Criteria: * Is a male between 40 and 95 years of age * Has osteoporosis * Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip * Is ambulatory Exclusion Criteria: * Is currently on oral bisphosphonates or other treatment for osteoporosis *...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Precision BioSciences, Inc. | DTIL | 1 | N/A | Undisclosed |
| SI-BONE, Inc. | SIBN | 1 | - | Undisclosed |
Odanacatib is an investigational small molecule being developed for the treatment of osteoporosis, including postmenopausal osteoporosis. It is a cathepsin K inhibitor that is being studied for its potential to reduce bone resorption and improve bone mineral density in patients with this condition.
Odanacatib is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 2 clinical development for the treatment of osteoporosis.
Odanacatib is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for the treatment of osteoporosis, including postmenopausal osteoporosis, in clinical trials.
Odanacatib has been studied in several clinical trials, including NCT00620113, a Phase 2 study in postmenopausal osteoporosis with 287 participants, and multiple Phase 1 trials such as NCT00769418, NCT00863525, and NCT00863590, which evaluated safety, tolerability, and pharmacokinetics in healthy volunteers.
Odanacatib works by inhibiting cathepsin K, an enzyme involved in bone resorption. By blocking this enzyme, the drug aims to reduce bone breakdown and help maintain bone density in patients with osteoporosis.
Yes, Odanacatib is also known as MK-0822. Clinical trials for the drug, such as NCT00620113, refer to it by this alternative name. Both names refer to the same investigational compound being developed by Merck.