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Cooperstown Cocktail
Cooperstown Cocktail is a Small molecule drug developed by Tesaro, Inc.. It is currently in Phase 1 development.
The Cooperstown Cocktail is a combination of midazolam, warfarin, vitamin K, caffeine, omeprazole, and dextromethorphan. It has been studied in clinical trials for various conditions, including Alzheimer's disease, prostate cancer, and chemotherapy-induced nausea and vomiting, as part of a drug interaction study with the potential Alzheimer's disease compound BMS-708163.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Cooperstown Cocktail |
|---|---|
| Sponsor | Tesaro, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety, Tolerability, Pharmacokinetics, and Efficacy of Acapatamab in Subjects With mCRPC (PHASE1)
- Open Label Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 in Healthy Volunteers (PHASE1)
- An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects (PHASE1)
- A Study To Evaluate The Effect of T89(Dantonic®)On P450 Enzymes (PHASE1)
- TMC435-TiDP16-C107: This Study Measures the (Possible) Influence of TMC435 on the Activity of a Selected Set of Drug-degrading Proteins by Measuring the Blood Levels of Drugs That Have Been Taken Together With TMC435 and That Are Known to be Specifically Degraded by These Drug-degrading Proteins. (PHASE1)
- Drug Interaction Study With a Potential Alzheimer's Disease Compound (PHASE1)
- Comparative Effects of Azithromycin, Telithromycin and Levofloxacin on Drug Metabolizing Enzymes (PHASE4)
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:
- Cooperstown Cocktail CI brief — competitive landscape report
- Cooperstown Cocktail updates RSS · CI watch RSS
- Tesaro, Inc. portfolio CI
Frequently asked questions about Cooperstown Cocktail
What is Cooperstown Cocktail?
Who makes Cooperstown Cocktail?
What development phase is Cooperstown Cocktail in?
Related
- Manufacturer: Tesaro, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing