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Test formulation administered with water
Test formulation administered with water is a Small molecule drug developed by Pfizer. It is currently in Phase 1 development. Also known as: ALO-02 20 mg.
Test formulation, administered with water, is a small molecule intervention used to study conditions such as allergy, pharmacokinetics, bioequivalence, type 2 diabetes, and biological availability. The formulation, which includes cetirizine 10mg and midomafetamine, has been studied in a randomized, single-dose, four-treatment crossover bioequivalence and food effect study.
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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). -
Big-pharma sponsor
+3.0pp
Pfizer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Test formulation administered with water |
|---|---|
| Also known as | ALO-02 20 mg |
| Sponsor | Pfizer |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- The Acute Effects of Onnit Alpha Brain on Cognition and Mood States (NA)
- Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes (PHASE1)
- A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body (PHASE1)
- A Study to Test How Different Doses of Nerandomilast (BI 1015550) Are Taken up in the Body of Healthy Japanese Men (PHASE1)
- MitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction (PHASE2, PHASE3)
- A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 706321 in the Blood (PHASE1)
- FHND1002 for ALS Treatment: Phase 2 (PHASE2)
- Crossover, Single Dose, Two-stage Bioequivalence Study of SCMC-Lys Salt 1.35 g Powder vs SCMC-Lys Salt 90 mg/mL Syrup (PHASE1)
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:
- Test formulation administered with water CI brief — competitive landscape report
- Test formulation administered with water updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Test formulation administered with water
What is Test formulation administered with water?
Who makes Test formulation administered with water?
Is Test formulation administered with water also known as anything else?
What development phase is Test formulation administered with water in?
Related
- Manufacturer: Pfizer — full pipeline
- Also known as: ALO-02 20 mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing