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Placebo for Abemaciclib
Placebo for Abemaciclib is a Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 3 development for Control arm in phase 3 clinical trials of abemaciclib.
A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect.
A placebo contains no active pharmaceutical ingredient and produces no direct pharmacological effect. Used for Control arm in phase 3 clinical trials of abemaciclib.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
Big-pharma sponsor
+3.0pp
Eli Lilly and Company 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 | 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 | Placebo for Abemaciclib |
|---|---|
| Sponsor | Eli Lilly and Company |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Placebo is an inert substance used as a control in clinical trials to establish the efficacy of the active drug (abemaciclib) by comparison. Any observed effects in the placebo arm are attributed to natural disease progression, regression to the mean, or the placebo effect itself. Placebos are essential for blinded trial design to eliminate bias and accurately measure the true therapeutic benefit of the investigational drug.
Approved indications
- Control arm in phase 3 clinical trials of abemaciclib
Common side effects
Key clinical trials
- A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) (PHASE3)
- A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer (PHASE3)
- Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (PHASE3)
- A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (PHASE3)
- A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (PHASE3)
- Effect of Salovum™ and SPC-Flakes™ on Abemaciclib-induced Gastrointestinal Toxicity in Early Breast Cancer (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:
- Placebo for Abemaciclib CI brief — competitive landscape report
- Placebo for Abemaciclib updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about Placebo for Abemaciclib
What is Placebo for Abemaciclib?
How does Placebo for Abemaciclib work?
What is Placebo for Abemaciclib used for?
Who makes Placebo for Abemaciclib?
What development phase is Placebo for Abemaciclib in?
Related
- Manufacturer: Eli Lilly and Company — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Control arm in phase 3 clinical trials of abemaciclib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing