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Baricitinib + dexamethasone
Baricitinib + dexamethasone is a JAK inhibitor + corticosteroid combination Small molecule drug developed by Instituto de Investigación Hospital Universitario La Paz. It is currently in Phase 3 development for COVID-19 (severe respiratory disease), Severe inflammatory respiratory conditions.
Baricitinib inhibits JAK1/JAK2 kinases to suppress inflammatory cytokine signaling, while dexamethasone provides additional glucocorticoid-mediated immunosuppression.
Baricitinib in combination with dexamethasone is being studied as a potential treatment for various conditions, including SARS-CoV-2 Infection, COVID-19, and COVID-19 Severe Respiratory Failure. The exact mechanism of action of baricitinib + dexamethasone is not specified in the provided facts, but baricitinib is known to be a Janus kinase (JAK) inhibitor, according to ChEMBL.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Baricitinib + dexamethasone |
|---|---|
| Sponsor | Instituto de Investigación Hospital Universitario La Paz |
| Drug class | JAK inhibitor + corticosteroid combination |
| Target | JAK1/JAK2 + glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Baricitinib is a JAK inhibitor that blocks Janus kinase signaling, reducing production of pro-inflammatory cytokines like IL-6 and TNF-α. Dexamethasone is a corticosteroid that suppresses immune cell activation and inflammatory mediator release. The combination targets multiple points in the inflammatory cascade, particularly relevant in severe inflammatory conditions such as COVID-19 or severe respiratory infections.
Approved indications
- COVID-19 (severe respiratory disease)
- Severe inflammatory respiratory conditions
Common side effects
- Infection (bacterial, viral, fungal)
- Hyperglycemia
- Hypertension
- Thromboembolism
- Insomnia
- Mood changes
Key clinical trials
- Vitiligo, New Treatment and Serum s100B (PHASE2, PHASE3)
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (PHASE3)
- Baricitinib in Hospitalized Covid-19 Patients With Diabetes Mellitus (PHASE3)
- Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19 (PHASE3)
- Randomised Evaluation of COVID-19 Therapy (PHASE3)
- Low-dose Baricitinib Plus High-dose Dexamethasone for Patients With Newly Diagnosed Immune Thrombocytopenia (PHASE2)
- Study of Efficacy of Different Treatment Regimens of Olokizumab (PHASE3)
- Adaptive COVID-19 Treatment Trial 4 (ACTT-4) (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:
- Baricitinib + dexamethasone CI brief — competitive landscape report
- Baricitinib + dexamethasone updates RSS · CI watch RSS
- Instituto de Investigación Hospital Universitario La Paz portfolio CI
Frequently asked questions about Baricitinib + dexamethasone
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Related
- Drug class: All JAK inhibitor + corticosteroid combination drugs
- Target: All drugs targeting JAK1/JAK2 + glucocorticoid receptor
- Manufacturer: Instituto de Investigación Hospital Universitario La Paz — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for COVID-19 (severe respiratory disease)
- Indication: Drugs for Severe inflammatory respiratory conditions
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing