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Placebo Tablet: BID
Placebo Tablet: BID is a Small molecule drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc.. It is currently in Phase 3 development for Control arm in phase 3 clinical trial (specific indication unknown).
Placebo has no active pharmacological mechanism; it is an inert substance used as a control in clinical trials.
A Placebo Tablet taken BID (twice a day) is used as a control intervention in clinical trials to compare the effects of other treatments. The Placebo Tablet is a small molecule, as classified by ChEMBL, and has been used in studies for various conditions including COVID-19 Pneumonia, Irritable Bowel Syndrome, and Atrial Fibrillation.
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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 Tablet: BID |
|---|---|
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Placebo tablets are inactive formulations designed to match the appearance and administration schedule of an active drug. They serve as the control arm in randomized controlled trials to measure the effect of the investigational drug against baseline and psychological expectation effects. Any observed benefit in the placebo group is attributed to natural disease progression, regression to the mean, or the placebo effect itself.
Approved indications
- Control arm in phase 3 clinical trial (specific indication unknown)
Common side effects
Key clinical trials
- The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral Artery Disease (PHASE4)
- Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies (PHASE1)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- A Study of LY4268989 (MORF-057) in Healthy Participants (PHASE1)
- Dronabinol in Total Knee Arthroplasty (TKA) (PHASE4)
- Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis (PHASE2)
- A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease (PHASE3)
- A Phase 2 Study of CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis (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 Tablet: BID CI brief — competitive landscape report
- Placebo Tablet: BID updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI
Frequently asked questions about Placebo Tablet: BID
What is Placebo Tablet: BID?
How does Placebo Tablet: BID work?
What is Placebo Tablet: BID used for?
Who makes Placebo Tablet: BID?
What development phase is Placebo Tablet: BID in?
Related
- Manufacturer: Otsuka Pharmaceutical Development & Commercialization, Inc. — full pipeline
- Indication: Drugs for Control arm in phase 3 clinical trial (specific indication unknown)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing