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Dexamethasone (intravenous)
Dexamethasone (intravenous) is a Glucocorticoid (corticosteroid) Small molecule drug developed by Poznan University of Medical Sciences. It is currently in Phase 3 development for Cerebral edema associated with primary or metastatic brain tumors, Severe inflammatory or allergic conditions, Acute respiratory distress syndrome (ARDS).
Dexamethasone is a synthetic glucocorticoid that suppresses the immune system and reduces inflammation by binding to glucocorticoid receptors in the cytoplasm.
Dexamethasone, a small molecule, is used intravenously to treat various conditions, including Arthropathy of Knee, Hip Dysplasia, Postoperative Complications, Shoulder Injury, and Relapsing Multiple Sclerosis. It is administered in the form of Dexamethasone Sodium Phosphate or Dexamethasone itself, often as part of a clinical trial or study.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| 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 | Dexamethasone (intravenous) |
|---|---|
| Sponsor | Poznan University of Medical Sciences |
| Drug class | Glucocorticoid (corticosteroid) |
| Target | Glucocorticoid receptor (GR) |
| Modality | Small molecule |
| Therapeutic area | Immunology, Inflammation, Oncology (supportive care) |
| Phase | Phase 3 |
Mechanism of action
Dexamethasone enters cells and binds to intracellular glucocorticoid receptors, which then translocate to the nucleus and modulate gene transcription. This leads to decreased production of pro-inflammatory cytokines, reduced immune cell activation and proliferation, and suppression of inflammatory mediators. The intravenous formulation provides rapid systemic delivery for acute inflammatory or immunological conditions.
Approved indications
- Cerebral edema associated with primary or metastatic brain tumors
- Severe inflammatory or allergic conditions
- Acute respiratory distress syndrome (ARDS)
- Septic shock
Common side effects
- Hyperglycemia
- Hypertension
- Insomnia
- Mood changes (agitation, anxiety)
- Immunosuppression / increased infection risk
- Hypokalemia
- Gastrointestinal upset
Key clinical trials
- Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) (PHASE3)
- A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) (PHASE3)
- A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019) (PHASE3)
- A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) (PHASE3)
- Isatuximab, Pomalidomide, Elotuzumab and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma (PHASE2)
- Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007) (PHASE3)
- A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02) (PHASE1, PHASE2)
- A Study of GR1803 Injection Versus Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Participants With Relapsed or Refractory Multiple Myeloma (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:
- Dexamethasone (intravenous) CI brief — competitive landscape report
- Dexamethasone (intravenous) updates RSS · CI watch RSS
- Poznan University of Medical Sciences portfolio CI
Frequently asked questions about Dexamethasone (intravenous)
What is Dexamethasone (intravenous)?
How does Dexamethasone (intravenous) work?
What is Dexamethasone (intravenous) used for?
Who makes Dexamethasone (intravenous)?
What drug class is Dexamethasone (intravenous) in?
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What does Dexamethasone (intravenous) target?
Related
- Drug class: All Glucocorticoid (corticosteroid) drugs
- Target: All drugs targeting Glucocorticoid receptor (GR)
- Manufacturer: Poznan University of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Immunology, Inflammation, Oncology (supportive care)
- Indication: Drugs for Cerebral edema associated with primary or metastatic brain tumors
- Indication: Drugs for Severe inflammatory or allergic conditions
- Indication: Drugs for Acute respiratory distress syndrome (ARDS)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing