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Placebo every 4 weeks
Placebo every 4 weeks is a Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 3 development.
Placebo produces no pharmacological effect and serves as a control comparator in clinical trials.
Here's a 2-sentence factual summary of Placebo every 4 weeks: **Week 1** Placebo is a control intervention used in clinical trials to compare the effects of a treatment against a standard or inactive treatment. In clinical trials, Placebo has been used to study various conditions, including Persistent Allergic Asthma, Limited-Stage Small Cell Lung Cancer, and Crohn's Disease With Perianal Fistulas. **Week 5** Placebo is used as a control intervention in clinical trials to evaluate the efficacy of treatments, such as Omalizumab, in conditions like Persistent Allergic Asthma. Placebo is often used in parallel-group, double-blind, randomized studies to compare treatment outcomes. **Week 9** Placebo is an inactive treatment used in clinical trials to compare the effects of a treatment against a standard or inactive treatment. In a 24-week, Phase III randomized, double-blind, placebo-controlled study, Placebo was used to evaluate the efficacy of Omalizumab in patients with Persistent Allergic Asthma. **Week 13** Placebo is a control intervention used in clinical trials to compare the effects of a treatment against a standard or inactive treatment. Placebo has been used in various clinical trials, including studies on Limited-Stage Small Cell Lung Cancer and Cancer Survivors. **Week 17** Placebo is used as a control intervention in clinical trials to evaluate the efficacy of treatments, such as HLX10, in conditions like Crohn's Disease With Perianal Fistulas. Placebo is often used in parallel-group, double-blind, randomized studies to compare treatment outcomes. **Week 21** Placebo is an inactive treatment used in clinical trials to compare the effects of a treatment against a standard or inactive treatment. In a clinical trial, Placebo was used to study the effects of Omalizumab in patients with Persistent Allergic Asthma. **Week 25** Placebo is a control intervention used
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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). -
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 every 4 weeks |
|---|---|
| Sponsor | Eli Lilly and Company |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebo is an inert substance administered in blinded clinical trials to establish a baseline for comparison against active drug treatments. It allows researchers to distinguish genuine drug efficacy from placebo response and natural disease progression. The every-4-weeks dosing schedule matches the active comparator arm in this Phase 3 trial.
Approved indications
Common side effects
Key clinical trials
- Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC) (PHASE2, PHASE3)
- A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus (PHASE2, PHASE3)
- A Study of Barzolvolimab in Patients With Atopic Dermatitis (PHASE2)
- Effects of NAC on Symptoms of CHR Patients (NA)
- A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study) (PHASE2)
- Tocilizumab in Lung Transplantation (PHASE2)
- Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (PHASE2)
- A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy (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 every 4 weeks CI brief — competitive landscape report
- Placebo every 4 weeks updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about Placebo every 4 weeks
What is Placebo every 4 weeks?
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What development phase is Placebo every 4 weeks in?
Related
- Manufacturer: Eli Lilly and Company — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing