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Zoledronic Acid; Letrozole
Zoledronic Acid; Letrozole is a Small molecule drug developed by Novartis. It is currently in Phase 2 development.
Zoledronic acid is a medication used to treat conditions such as osteoporosis and breast cancer, particularly in postmenopausal women. It is often used in combination with letrozole, a hormone therapy, as an extended adjuvant treatment for primary breast cancer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Novartis is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Zoledronic Acid; Letrozole |
|---|---|
| Sponsor | Novartis |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer. (PHASE3)
- Delayed Versus Immediate Use Of Zoledronic Acid For Postmenopausal Patients With Early Breast Cancer Who Are Using Adjuvant Letrozole (PHASE3)
- Zoledronate in Treating Osteopenia or Osteoporosis in Postmenopausal Women Receiving Letrozole for Stage I, Stage II, or Stage IIIA Primary Breast Cancer (NA)
- Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms (PHASE2)
- Efficacy and Safety of Letrozole vs. Letrozole Plus Zoledronic Acid as Endocrine Therapy Before Surgery in Postmenopausal Patients With Breast Cancer (PHASE4)
- Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy (PHASE2)
- Zoledronate in Preventing Bone Loss in Postmenopausal Women Who Are Receiving Letrozole for Stage I, Stage II, or Stage IIIA Breast Cancer (PHASE3)
- Extended Endocrine Therapy for Premenopausal Women With Breast Cancer (PHASE2)
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:
- Zoledronic Acid; Letrozole CI brief — competitive landscape report
- Zoledronic Acid; Letrozole updates RSS · CI watch RSS
- Novartis portfolio CI
Frequently asked questions about Zoledronic Acid; Letrozole
What is Zoledronic Acid; Letrozole?
Who makes Zoledronic Acid; Letrozole?
What development phase is Zoledronic Acid; Letrozole in?
Related
- Manufacturer: Novartis — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing