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Loratadine oral solution
Loratadine oral solution is a Small molecule drug developed by Bayer. It is currently in Phase 1 development.
Loratadine oral solution is used to treat conditions such as rhinoconjunctivitis, rhinitis, and conjunctivitis, which are associated with allergies. It works by inducing an immune response, although its exact mechanism is not specified in the provided information.
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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
Bayer 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 | Loratadine oral solution |
|---|---|
| Sponsor | Bayer |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC) (PHASE3)
- A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme (PHASE4)
- A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic Conjunctivitis (PHASE4)
- Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Cetirizine HCl Syrup vs. Loratadine Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR) (PHASE4)
- Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED) (PHASE3)
- Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED) (PHASE3)
- To Assess Bioequivalence of Loratadine Oral Solution/Syrup Versus Claritin Peach Syrup (PHASE1)
- Patient Experience Study of Deoxycholic Acid Injection (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:
- Loratadine oral solution CI brief — competitive landscape report
- Loratadine oral solution updates RSS · CI watch RSS
- Bayer portfolio CI
Frequently asked questions about Loratadine oral solution
What is Loratadine oral solution?
Who makes Loratadine oral solution?
What development phase is Loratadine oral solution in?
Related
- Manufacturer: Bayer — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing