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Aclasta
Aclasta is a Small molecule drug developed by Mel Shiuann-Sheng Lee. It is currently in Phase 3 development.
Aclasta, also known as zoledronic acid, is a medication used to treat various bone diseases, including osteoporosis and bone breakdown due to cancer. It works by inhibiting the enzyme farnesyl diphosphate synthase, a small molecule inhibitor of this enzyme.
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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 | Aclasta |
|---|---|
| Sponsor | Mel Shiuann-Sheng Lee |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Romosozumab as an Adjunct to Physiologic Estrogen Replacement in Functional Hypothalamic Amenorrhea (PHASE3)
- Zoledronic Acid Treatment in Patients With Congenital Dyserythropoietic Anemia (PHASE1, PHASE2)
- Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors (PHASE1, PHASE2)
- Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults (PHASE2)
- Zoledronate In the Prevention of Paget's Disease: Long Term Extension
- Romosozumab Use to Build Skeletal Integrity (PHASE4)
- Contribution of Bone to Urine Citrate
- The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation (PHASE4)
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:
- Aclasta CI brief — competitive landscape report
- Aclasta updates RSS · CI watch RSS
- Mel Shiuann-Sheng Lee portfolio CI
Frequently asked questions about Aclasta
What is Aclasta?
Who makes Aclasta?
What development phase is Aclasta in?
Related
- Manufacturer: Mel Shiuann-Sheng Lee — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing