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Bentelan
Bentelan is a Corticosteroid Small molecule drug developed by A.O.U. Città della Salute e della Scienza. It is currently in Phase 3 development. Also known as: Betamethasone.
Betamethasone binds to glucocorticoid receptors, modulating gene transcription to suppress inflammation and immune responses.
Bentelan is an aerosol spray used to treat various skin conditions, including plaque psoriasis, according to a Phase 2a trial. It has also been studied for other conditions such as central centrifugal cicatricial alopecia, oral lichen planus, and recurrent aphthous stomatitis.
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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 | Bentelan |
|---|---|
| Also known as | Betamethasone |
| Sponsor | A.O.U. Città della Salute e della Scienza |
| Drug class | Corticosteroid |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Mechanism of action
Betamethasone is a synthetic glucocorticoid that binds to intracellular glucocorticoid receptors. The receptor-ligand complex translocates to the nucleus where it regulates gene expression, inhibiting pro-inflammatory mediators and suppressing immune cell function, resulting in potent anti-inflammatory and immunosuppressive effects.
Approved indications
Common side effects
Key clinical trials
- Comparative Bioavailability Study Between Etoricoxib / Betamethasone Administered Individually or in Combination (PHASE1)
- Evaluation the Topical Apremilast Nanoformulation in Treatment of Localized Plaque Psoriasis (NA)
- Assessing Psoriasis Treatment Outcomes (NA)
- A Phase III Trial To Evaluate The Efficacy And Safety Of MC2-01 Cream Compared To CAL/BDP Gel and Vehicle In Plaque Psoriasis Subjects (PHASE3)
- Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty (NA)
- Ropiclobet for Regional Anesthesia and Post-Operative Pain Control in Upper Extremity Surgery (PHASE2)
- Single Dose of Antenatal Corticosteroids for Pregnancies at Risk of Preterm Delivery (SNACS) (PHASE4)
- Betamethasone and Complications of Lower Third Molar Surgery (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:
- Bentelan CI brief — competitive landscape report
- Bentelan updates RSS · CI watch RSS
- A.O.U. Città della Salute e della Scienza portfolio CI
Frequently asked questions about Bentelan
What is Bentelan?
How does Bentelan work?
Who makes Bentelan?
Is Bentelan also known as anything else?
What drug class is Bentelan in?
What development phase is Bentelan in?
Related
- Drug class: All Corticosteroid drugs
- Manufacturer: A.O.U. Città della Salute e della Scienza — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Betamethasone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing