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Placebo TDS
Placebo TDS is a Small molecule drug developed by Senju USA, Inc.. It is currently in Phase 3 development for Treatment of dry eye.
Placebo transdermal system (TDS) has been used as a control intervention in clinical trials studying various conditions, including postoperative pain, feeding intolerance, and premature birth. Placebo TDS has also been used to compare the effects of buprenorphine transdermal patch and naltrexone tablet on electrocardiogram (ECG) intervals in healthy volunteers.
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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 TDS |
|---|---|
| Sponsor | Senju USA, Inc. |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
- Treatment of dry eye
Common side effects
- Eye pain
- Headache
- Eye irritation
Key clinical trials
- PVX4 for the Treatment of Human Papilloma Virus (HPV)16+ Cervical Dysplasia (PHASE2)
- Comparison Of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy (PHASE1)
- Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure. (NA)
- Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial) (PHASE4)
- Oral Dydrogesterone as Luteal Phase Support in Natural Cycle FET (PHASE3)
- Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD) (PHASE2)
- Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS) (PHASE1)
- Berberine and Cinnamon in Management of Diabetes (NA)
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 TDS CI brief — competitive landscape report
- Placebo TDS updates RSS · CI watch RSS
- Senju USA, Inc. portfolio CI
Frequently asked questions about Placebo TDS
What is Placebo TDS?
What is Placebo TDS used for?
Who makes Placebo TDS?
What development phase is Placebo TDS in?
What are the side effects of Placebo TDS?
Related
- Manufacturer: Senju USA, Inc. — full pipeline
- Indication: Drugs for Treatment of dry eye
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing