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risedronate combine
risedronate combine is a Bisphosphonate Small molecule drug developed by Hanlim Pharm. Co., Ltd.. It is currently in Phase 3 development for Treatment of osteoporosis in postmenopausal women. Also known as: - Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined).
Risedronate combines with other medications to inhibit bone resorption by acting on osteoclasts.
Risedronate is a small molecule inhibitor of farnesyl diphosphate synthase, classified as an INHIBITOR. It is used to treat postmenopausal women with osteoporosis, as indicated by clinical trials.
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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 | risedronate combine |
|---|---|
| Also known as | - Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined) |
| Sponsor | Hanlim Pharm. Co., Ltd. |
| Drug class | Bisphosphonate |
| Target | Hydroxyapatite |
| Modality | Small molecule |
| Therapeutic area | Osteoporosis |
| Phase | Phase 3 |
Mechanism of action
Risedronate is a bisphosphonate that binds to hydroxyapatite in bone, inhibiting osteoclast-mediated bone resorption. This results in increased bone density and reduced risk of fractures.
Approved indications
- Treatment of osteoporosis in postmenopausal women
Common side effects
- Abdominal pain
- Nausea
- Diarrhea
- Headache
- Back pain
Key clinical trials
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:
- risedronate combine CI brief — competitive landscape report
- risedronate combine updates RSS · CI watch RSS
- Hanlim Pharm. Co., Ltd. portfolio CI
Frequently asked questions about risedronate combine
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Related
- Drug class: All Bisphosphonate drugs
- Target: All drugs targeting Hydroxyapatite
- Manufacturer: Hanlim Pharm. Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Osteoporosis
- Indication: Drugs for Treatment of osteoporosis in postmenopausal women
- Also known as: - Other name : Risenex M(risedronate 150mg and cholecalciferol 30,000 IU combined)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing