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Fablyn (LASOFOXIFENE)
At a glance
| Generic name | LASOFOXIFENE |
|---|---|
| Sponsor | Dr. Friedrich Eberth Arzneimittel GmbH |
| Drug class | lasofoxifene |
| Target | Estrogen receptor |
| Modality | Small molecule |
| Therapeutic area | Bone |
| Phase | FDA-approved |
| First approval | 2009 |
Approved indications
- Postmenopausal osteoporosis
Common side effects
Key clinical trials
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
- Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (PHASE2)
- Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (PHASE3)
- Open-Label Study of Vaginal AZU-101 in Postmenopausal Women (PHASE1,PHASE2)
- Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (PHASE2)
- Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL) (PHASE3)
- Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss (PHASE3)
- The Prevention Of Postmenopausal Osteoporosis With Lasofoxifene And Cytokine Evaluation (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Fablyn CI brief — competitive landscape report
- Fablyn updates RSS · CI watch RSS
- Dr. Friedrich Eberth Arzneimittel GmbH portfolio CI