Last reviewed · How we verify
Minodronic acid hydrate
Minodronic acid hydrate is a Bisphosphonate Small molecule drug developed by Ono Pharmaceutical Co. Ltd. It is currently in Phase 3 development for Osteoporosis in postmenopausal women, Bone loss associated with cancer treatment.
Minodronic acid is a bisphosphonate that inhibits osteoclast-mediated bone resorption by blocking farnesyl pyrophosphate synthase in the mevalonate pathway.
Minodronic acid hydrate is used to treat conditions such as osteoporosis, involutional osteoporosis, and postmenopausal osteoporosis. It is a medication that has been studied in clinical trials, including a Phase III trial for postmenopausal women with osteoporosis.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Minodronic acid hydrate |
|---|---|
| Sponsor | Ono Pharmaceutical Co. Ltd |
| Drug class | Bisphosphonate |
| Target | Farnesyl pyrophosphate synthase |
| Modality | Small molecule |
| Therapeutic area | Bone metabolism / Osteoporosis |
| Phase | Phase 3 |
Mechanism of action
As a nitrogen-containing bisphosphonate, minodronic acid accumulates in bone and is taken up by osteoclasts during bone resorption. It inhibits farnesyl pyrophosphate synthase, disrupting the prenylation of small GTPases essential for osteoclast function and survival, thereby reducing bone turnover and increasing bone mineral density.
Approved indications
- Osteoporosis in postmenopausal women
- Bone loss associated with cancer treatment
Common side effects
- Musculoskeletal pain
- Gastrointestinal upset
- Jaw osteonecrosis (ONJ)
- Atypical fractures
Key clinical trials
- Efficacy and Safety of Minodronate in Patients With Low Back Pain (PHASE4)
- A Phase III Clinical Study of Minodronate Tablets in Postmenopausal Women With Osteoporosis (PHASE3)
- Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese
- Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Minodronic acid hydrate CI brief — competitive landscape report
- Minodronic acid hydrate updates RSS · CI watch RSS
- Ono Pharmaceutical Co. Ltd portfolio CI
Frequently asked questions about Minodronic acid hydrate
What is Minodronic acid hydrate?
How does Minodronic acid hydrate work?
What is Minodronic acid hydrate used for?
Who makes Minodronic acid hydrate?
What drug class is Minodronic acid hydrate in?
What development phase is Minodronic acid hydrate in?
What are the side effects of Minodronic acid hydrate?
What does Minodronic acid hydrate target?
Related
- Drug class: All Bisphosphonate drugs
- Target: All drugs targeting Farnesyl pyrophosphate synthase
- Manufacturer: Ono Pharmaceutical Co. Ltd — full pipeline
- Therapeutic area: All drugs in Bone metabolism / Osteoporosis
- Indication: Drugs for Osteoporosis in postmenopausal women
- Indication: Drugs for Bone loss associated with cancer treatment
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing