A Two-part, Crossover Study to Investigate the Effects of Morning Versus Evening Dosing and Food Interaction on the Pharmacodynamics and Pharmacokinetics of Single and Multiple Doses of ONO-5334 in Healthy Post Menopausal Women

The study will investigate the effects on pharmacodynamics and pharmacokinetics of food and morning versus evening on single and multiple doses of ONO-5334 in healthy post menopausal women.

Start Date01 Jun 2011

Sponsor / Collaborator

Ono Pharmaceutical Co., Ltd.

NCT00532337 / CompletedPhase 2

A Multi-centre, Randomized, Double Blind, Parallel Group Study to Investigate Efficacy and Safety of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.

Start Date01 Oct 2007

Sponsor / Collaborator

Ono Pharma USA, Inc.

EUCTR2007-002417-39-EE / Not yet recruitingNot Applicable

A MULTI-CENTRE RANDOMISED DOUBLE BLIND, PLACEBO AND ACTIVE CONTROLLED PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ONO-5334 IN POST MENOPAUSAL WOMEN WITH OSTEOPENIA OR OSTEOPOROSIS

Start Date25 Sep 2007

Sponsor / Collaborator

Ono Pharmaceutical Co., Ltd.

100 Clinical Results associated with ONO-5334

100 Translational Medicine associated with ONO-5334

100 Patents (Medical) associated with ONO-5334

Literatures (Medical) associated with ONO-5334

01 Oct 2020·NatureQ1 · CROSS-FIELD

Discovery of SARS-CoV-2 antiviral drugs through large-scale compound repurposing

Q1 · CROSS-FIELD

Article

Author: Mesecar, Andrew D ; Burgstaller-Muehlbacher, Sebastian ; Cheng, Kuoyuan ; Liu, Wen-Chun ; White, Kris M ; García-Sastre, Adolfo ; Herbert, Kristina M ; Ruppin, Eytan ; Zwaka, Thomas P ; Poon, Vincent Kwok-Man ; Schotsaert, Michael ; De Jesus, Paul D ; Nguyen, Tu-Trinh H ; Martinez-Sobrido, Luis ; Su, Andrew I ; Matsunaga, Naoko ; Choi, Angela ; Albrecht, Randy ; Benner, Christopher ; Schultz, Peter G ; Pu, Yuan ; Sun, Ren ; Rubanov, Andrey ; Sit, Ko-Yung ; Chanda, Sumit K ; Glynne, Richard J ; Rathnasinghe, Raveen ; Hull, Mitchell V ; Chang, Max W ; Pache, Lars ; Lendy, Emma K ; Chan, Jasper Fuk-Woo ; Chatterjee, Arnab K ; Yuan, Shuofeng ; Miorin, Lisa ; Cao, Jianli ; Yin, Xin ; Martin-Sancho, Laura ; Chapman, Mackenzie E ; Dejosez, Marion ; Johnson, Jeffrey R ; Nguyen, Courtney ; Yuen, Kwok-Yung ; Teriete, Peter ; Riva, Laura

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2019 has triggered an ongoing global pandemic of the severe pneumonia-like disease coronavirus disease 2019 (COVID-19)¹. The development of a vaccine is likely to take at least 12-18 months, and the typical timeline for approval of a new antiviral therapeutic agent can exceed 10 years. Thus, repurposing of known drugs could substantially accelerate the deployment of new therapies for COVID-19. Here we profiled a library of drugs encompassing approximately 12,000 clinical-stage or Food and Drug Administration (FDA)-approved small molecules to identify candidate therapeutic drugs for COVID-19. We report the identification of 100 molecules that inhibit viral replication of SARS-CoV-2, including 21 drugs that exhibit dose-response relationships. Of these, thirteen were found to harbour effective concentrations commensurate with probable achievable therapeutic doses in patients, including the PIKfyve kinase inhibitor apilimod^2-4 and the cysteine protease inhibitors MDL-28170, Z LVG CHN2, VBY-825 and ONO 5334. Notably, MDL-28170, ONO 5334 and apilimod were found to antagonize viral replication in human pneumocyte-like cells derived from induced pluripotent stem cells, and apilimod also demonstrated antiviral efficacy in a primary human lung explant model. Since most of the molecules identified in this study have already advanced into the clinic, their known pharmacological and human safety profiles will enable accelerated preclinical and clinical evaluation of these drugs for the treatment of COVID-19.

01 Jul 2019·Journal of Bone and Mineral MetabolismQ3 · MEDICINE

Cortical bone mineral density is increased by the cathepsin K inhibitor ONO-5334, which leads to a robust increase in bone strength: results from a 16-month study in ovariectomised cynomolgus monkeys

Q3 · MEDICINE

Article

Author: Deacon, Steve ; Yamada, Hiroyuki ; Nishikawa, Satoshi ; Ochi, Yasuo ; Mori, Hiroshi ; Kawabata, Kazuhito ; Tanaka, Makoto ; Hashimoto, Yasuaki

This study evaluated the long-term effects of the cathepsin K inhibitor ONO-5334 on bone mass and strength in ovariectomised (OVX) cynomolgus monkeys. Animals were assigned to one of the following six groups: Sham (non-OVX), OVX control treated with vehicle, ONO-5334 1.2, 6 or 30 mg/kg/day, p.o., or alendronate (ALN) 0.05 mg/kg/2 weeks, i.v. for 16 months. Peripheral quantitative computed tomography (pQCT) analysis revealed that ONO-5334 increased not only trabecular bone mineral density (BMD) but also cortical BMD in the distal radius and the lumbar vertebra. ONO-5334 and ALN suppressed the deterioration of trabecular architecture by micro-CT analysis in the distal radius. Assessments of bone strength showed that ONO-5334 increased maximum load at the distal and midshaft radius. The linear regression lines between bone mass and strength in the lumbar vertebra were tended to be shifted towards increasing bone strength in the ONO-5334 6 and 30 mg/kg groups compared with the ALN groups. This indicated that bone strength was higher in the ONO-5334 groups than the ALN group, even though bone mineral content (BMC) and BMD were comparable. Subpopulation analysis revealed that, at similar integral BMC or BMD level, cortical bone mass for ONO-5334 was higher than for ALN; the opposite effects were observed for trabecular bone. In conclusion, ONO-5334 preferentially increased cortical bone, which may provide a greater contribution to bone strength. Since these results support a different mode of action for ONO-5334 compared with that of ALN, ONO-5334 may offer new therapeutic options to patients with osteoporosis.

01 Jun 2019·British Journal of Clinical PharmacologyQ2 · MEDICINE

Clinical and translational pharmacology of the cathepsin K inhibitor odanacatib studied for osteoporosis

Q2 · MEDICINE

Review

Author: Witter, Rose ; Stone, Julie A. ; McCrea, Jacqueline B. ; Stoch, S. Aubrey ; Zajic, Stefan

Cathepsin K (CatK) is a cysteine protease abundantly expressed by osteoclasts and localized in the lysosomes and resorption lacunae of these cells. CatK is the principal enzyme responsible for the degradation of bone collagen. Odanacatib is a selective, reversible inhibitor of CatK at subnanomolar potency. The pharmacokinetics of odanacatib have been extensively studied and are similar in young healthy men, postmenopausal women and elderly men, and were qualitatively similar throughout Phase 1 development and in‐patient studies. Following 3 weeks of 50 mg once weekly dosing the geometric mean area under the curve from 0 to 168 hours was 41.1 μM h, the concentration at 168 hours was 126 nM and the harmonic mean apparent terminal half‐life was 84.8 hr. Odanacatib exposure increased in a less than dose proportional manner due to solubility limited absorption. It is estimated that approximately 70% of the absorbed dose of odanacatib is eliminated via metabolism, 20% is excreted as unchanged drug in the bile or faeces, and 10% is excreted as unchanged drug in the urine. The systemic clearance was low (approximately 13 mL/min). Odanacatib decreases the degradation of bone matrix proteins and reduces the efficiency of bone resorption with target engagement confirmed by a robust decrease in serum C‐telopeptides of type 1 collagen (approximately 60%), urinary aminoterminal crosslinked telopeptides of type 1 collagen to creatinine ratio (approximately 50%) and total urine deoxypyridinoline/Cr (approximately 30%), with an increase in serum cross‐linked carboxy‐terminal telopeptide of type 1 collagen (approximately 55%). The 50‐mg weekly dosing regimen evaluated in Phase 3 achieved near maximal reduction in bone resorption throughout the treatment period. The extensive clinical programme for odanacatib, together with more limited clinical experience with other CatK inhibitors (balicatib and ONO‐5334), provides important insights into the clinical pharmacology of CatK inhibition and the potential role of CatK in bone turnover and mineral homeostasis. Key findings include the ability of this mechanism to: (i) provide sustained reductions in resorption markers, increases in bone mineral density, and demonstrated fracture risk reduction; (ii) be associated with relative formation‐sparing effects such that sustained resorption reduction is achieved without accompanying meaningful reductions in bone formation; and (iii) lead to increases in osteoclast number as well as other osteoclast activity (including build‐up of CatK enzyme), which may yield transient increases in resorption following treatment discontinuation and the potential for nonmonotonic responses at subtherapeutic doses.

100 Deals associated with ONO-5334

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoporosis	Phase 2	EU	Ono Pharmaceutical Co., Ltd.	-
Osteoporosis	Phase 2	EU	Ono Pharmaceutical Co., Ltd.	-

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