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Placebo plus corticosteroid
Placebo plus corticosteroid is a Corticosteroid Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 3 development for Asthma, Chronic obstructive pulmonary disease (COPD). Also known as: Methylprednisolone.
Corticosteroids are anti-inflammatory agents that reduce inflammation by suppressing the immune system's response.
Corticosteroids are anti-inflammatory agents that reduce inflammation by suppressing the immune system's response. Used for Asthma, Chronic obstructive pulmonary disease (COPD).
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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 | Placebo plus corticosteroid |
|---|---|
| Also known as | Methylprednisolone |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Drug class | Corticosteroid |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
Corticosteroids work by binding to glucocorticoid receptors in cells, which then translocate to the nucleus and alter gene expression to reduce inflammation. This results in decreased production of pro-inflammatory cytokines and increased production of anti-inflammatory cytokines.
Approved indications
- Asthma
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Oral thrush
- Weight gain
- Insomnia
- Headache
- Nausea
Key clinical trials
- Tocilizumab in Lung Transplantation (PHASE2)
- A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1) (PHASE3)
- A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP) (PHASE3)
- Phase 2 Study to Evaluate RPT193 in Adults With Moderate to Severe T2-high Asthma (PHASE2)
- Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder (EARLY_PHASE1)
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- Hoffa's Fat Pad Impingement (HFPI) (PHASE4)
- A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis (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:
- Placebo plus corticosteroid CI brief — competitive landscape report
- Placebo plus corticosteroid updates RSS · CI watch RSS
- National Heart, Lung, and Blood Institute (NHLBI) portfolio CI
Frequently asked questions about Placebo plus corticosteroid
What is Placebo plus corticosteroid?
How does Placebo plus corticosteroid work?
What is Placebo plus corticosteroid used for?
Who makes Placebo plus corticosteroid?
Is Placebo plus corticosteroid also known as anything else?
What drug class is Placebo plus corticosteroid in?
What development phase is Placebo plus corticosteroid in?
What are the side effects of Placebo plus corticosteroid?
Related
- Drug class: All Corticosteroid drugs
- Manufacturer: National Heart, Lung, and Blood Institute (NHLBI) — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Asthma
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
- Also known as: Methylprednisolone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing