Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NE-58095 IR · 1 trial · 1 indication
The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.
| Arm | Type | Description |
|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | ACTIVE_COMPARATOR | NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 25 mg Once Monthly on Awakening | EXPERIMENTAL | NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | EXPERIMENTAL | NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | EXPERIMENTAL | NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | EXPERIMENTAL | NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | EXPERIMENTAL | NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | EXPERIMENTAL | NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| Name | Type | Description |
|---|---|---|
| NE-58095 IR | DRUG | NE-58095 IR tablets |
| NE-58095 IR Placebo | DRUG | NE-58095 IR placebo-matching tablets |
| NE-58095 DR | DRUG | NE-58095 DR tablets |
| NE-58095 DR Placebo | DRUG | NE-58095 DR placebo-matching tablets |
Inclusion Criteria: 1. Patients with a diagnosis of involutional osteoporosis 2. Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent 3. Women for whom at least 2 years have passed since the last natural menstruation Exclusion Cr...
NE-58095 IR is an investigational small molecule being developed for the treatment of involutional osteoporosis, a condition characterized by bone loss associated with aging. It is administered orally as a tablet. The drug is currently in clinical development and has not been approved for use.
NE-58095 IR is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company headquartered in Japan. Takeda's stock is listed on the New York Stock Exchange under the ticker symbol TAK. The company is conducting clinical trials for this investigational drug.
NE-58095 IR is in Phase 2 of clinical development. A Phase II/III study has been completed, but the drug remains investigational and is not yet approved by regulatory authorities. Further clinical development may be required before it can be considered for marketing approval.
NE-58095 IR has been studied in one completed clinical trial, identified as NCT02063854. This was a Phase II/III, double-blind, parallel group comparative study of oral NE-58095 tablets in patients with involutional osteoporosis. The trial enrolled 871 participants in Japan and was active-controlled.
NE-58095 IR is a distinct investigational drug developed by Takeda. It is a small molecule administered orally, and its mechanism of action has not been disclosed in available information. It is not known to be the same as any other marketed osteoporosis medication.