Last reviewed · How we verify
Placebo BAI
Placebo BAI is a Small molecule drug developed by Teva Branded Pharmaceutical Products R&D, Inc.. It is currently in Phase 3 development for Clinical trial control comparator (not a therapeutic indication). Also known as: breath-actuated inhaler.
Placebo BAI is an inert substance with no active pharmacological mechanism.
Placebo BAI is an inert substance with no active pharmacological mechanism. Used for Clinical trial control comparator (not a therapeutic indication).
-
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 BAI |
|---|---|
| Also known as | breath-actuated inhaler |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
As a placebo, this agent contains no active pharmaceutical ingredient and produces therapeutic effects solely through the placebo response—a psychobiological phenomenon where patient expectation and clinical context influence symptom perception and outcomes. Placebo BAI is used as a control comparator in clinical trials to distinguish true drug efficacy from placebo effects.
Approved indications
- Clinical trial control comparator (not a therapeutic indication)
Common side effects
Key clinical trials
- Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (PHASE3)
- CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial (PHASE2)
- Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab (PHASE2)
- ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression (PHASE2)
- Clinical and Laboratory Evaluation of Resveratrol Loaded Nanoparticles in the Treatment of Periodontitis: A Randomized Controlled Clinical Trial (PHASE1)
- A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis (PHASE2)
- Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections (PHASE3)
- Efficacy and Safety of Emodepside in Participants With Soil-transmitted Helminth Infections (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 BAI CI brief — competitive landscape report
- Placebo BAI updates RSS · CI watch RSS
- Teva Branded Pharmaceutical Products R&D, Inc. portfolio CI
Frequently asked questions about Placebo BAI
What is Placebo BAI?
How does Placebo BAI work?
What is Placebo BAI used for?
Who makes Placebo BAI?
Is Placebo BAI also known as anything else?
What development phase is Placebo BAI in?
Related
- Manufacturer: Teva Branded Pharmaceutical Products R&D, Inc. — full pipeline
- Indication: Drugs for Clinical trial control comparator (not a therapeutic indication)
- Also known as: breath-actuated inhaler
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing