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Bilastine & Ketoconazole
Bilastine & Ketoconazole is a Antihistamine (bilastine) / Azole antifungal and CYP3A4 inhibitor (ketoconazole) Small molecule drug developed by Faes Farma, S.A.. It is currently in Phase 1 development.
Bilastine blocks histamine H1 receptors to prevent allergic responses; ketoconazole inhibits fungal ergosterol synthesis and CYP3A4 metabolism.
Bilastine is a small molecule that acts as an inverse agonist at the Histamine H1 receptor. Bilastine & Ketoconazole was studied in a randomized, multiple dose, double-blind, 5-way crossover study to assess its electrocardiographic effects in healthy individuals.
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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 | Bilastine & Ketoconazole |
|---|---|
| Sponsor | Faes Farma, S.A. |
| Drug class | Antihistamine (bilastine) / Azole antifungal and CYP3A4 inhibitor (ketoconazole) |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
Bilastine is a selective histamine H1 receptor antagonist that prevents histamine-mediated allergic symptoms. Ketoconazole inhibits fungal cytochrome P450 enzyme lanosterol 14α-demethylase and also strongly inhibits human CYP3A4, making it useful for studying drug-drug interactions with bilastine metabolism.
Approved indications
Common side effects
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bilastine & Ketoconazole CI brief — competitive landscape report
- Bilastine & Ketoconazole updates RSS · CI watch RSS
- Faes Farma, S.A. portfolio CI
Frequently asked questions about Bilastine & Ketoconazole
What is Bilastine & Ketoconazole?
How does Bilastine & Ketoconazole work?
Who makes Bilastine & Ketoconazole?
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Related
- Drug class: All Antihistamine (bilastine) / Azole antifungal and CYP3A4 inhibitor (ketoconazole) drugs
- Manufacturer: Faes Farma, S.A. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing