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Placebo - first 24 weeks
Placebo - first 24 weeks is a Small molecule drug developed by University of Alabama at Birmingham. It is currently in Phase 3 development.
Placebo has no active pharmacological mechanism; it serves as a control comparator in clinical trials.
Placebo is a treatment that has been studied in various clinical trials for conditions such as smoking cessation, non-cystic fibrosis bronchiectasis, hyperkalemia, myelodysplastic syndromes, and psoriasis. Placebo has been used in conjunction with transcranial magnetic stimulation (TMS) sessions, evaluations, and CMS (no further information available) in these trials.
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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 | Placebo - first 24 weeks |
|---|---|
| Sponsor | University of Alabama at Birmingham |
| 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 an active investigational drug. Any observed effects are attributed to natural disease progression, regression to the mean, or the placebo effect (psychological/expectation-driven response). In this Phase 3 trial context, placebo allows researchers to isolate the true efficacy of the investigational agent.
Approved indications
Common side effects
Key clinical trials
- A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010) (PHASE3)
- Imaging Metabolic and Perfusion Changes in Acupuncture Therapy for Myofascial Pain Syndrome (NA)
- Glutathione in Mild Cognitive Impairment (EARLY_PHASE1)
- Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis (PHASE3)
- Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder (PHASE2)
- Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004) (PHASE3)
- The Impact of Dietary Salt on the Severity of Eczema (PHASE4)
- Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation (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:
- Placebo - first 24 weeks CI brief — competitive landscape report
- Placebo - first 24 weeks updates RSS · CI watch RSS
- University of Alabama at Birmingham portfolio CI
Frequently asked questions about Placebo - first 24 weeks
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What development phase is Placebo - first 24 weeks in?
Related
- Manufacturer: University of Alabama at Birmingham — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing