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Placebo - weeks 48 - 72
Placebo - weeks 48 - 72 is a Small molecule drug developed by University of Alabama at Birmingham. It is currently in Phase 3 development.
Placebo produces no pharmacological effect and serves as a control comparator in clinical trials.
Placebo was used in clinical trials for various conditions, including HIV Infections, Pregnancy, Autism Spectrum Disorders, Frontotemporal Dementia, and Rifampin-Resistant Pulmonary Tuberculosis. Specifically, Placebo was used as a maternal intervention in combination with infant nevirapine in a study on HIV Infections and Pregnancy.
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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 - weeks 48 - 72 |
|---|---|
| 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 baseline disease progression and distinguish true drug efficacy from natural disease course or psychological expectation effects. In this Phase 3 trial context (weeks 48-72), placebo recipients receive no active therapeutic intervention, allowing researchers to measure the true clinical benefit of the investigational agent being tested.
Approved indications
Common side effects
Key clinical trials
- Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese (PHASE2)
- A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy (PHASE2, PHASE3)
- NAD+ and Exercise in FA (NA)
- A Study of Lu AF82422 in Participants With Multiple System Atrophy (PHASE2)
- Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection (PHASE3)
- Effect of Gut Microbiome Intervention on Aging Via Oral FMT (EARLY_PHASE1)
- Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors (PHASE2)
- Evaluate TQ-A3334 Combined Nucleoside (Acid) Analogs in the First Treatment/Treatment of Chronic HBV Infection (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 - weeks 48 - 72 CI brief — competitive landscape report
- Placebo - weeks 48 - 72 updates RSS · CI watch RSS
- University of Alabama at Birmingham portfolio CI
Frequently asked questions about Placebo - weeks 48 - 72
What is Placebo - weeks 48 - 72?
How does Placebo - weeks 48 - 72 work?
Who makes Placebo - weeks 48 - 72?
What development phase is Placebo - weeks 48 - 72 in?
Related
- Manufacturer: University of Alabama at Birmingham — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing