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Antenatal steroids administration
Antenatal steroids administration is a Corticosteroid Small molecule drug developed by The Central and Eastern European Gynecologic Oncology Group. It is currently in Phase 3 development for Prevention of respiratory distress syndrome in preterm infants (gestational age 24–34 weeks at risk of preterm delivery), Reduction of neonatal mortality and morbidity in threatened preterm labor.
Antenatal steroids (typically corticosteroids like betamethasone or dexamethasone) accelerate fetal lung maturity by promoting surfactant production, reducing respiratory distress syndrome risk in preterm infants.
Antenatal steroids (typically corticosteroids like betamethasone or dexamethasone) accelerate fetal lung maturity by promoting surfactant production, reducing respiratory distress syndrome risk in preterm infants. Used for Prevention of respiratory distress syndrome in preterm infants (gestational age 24–34 weeks at risk of preterm delivery), Reduction of neonatal mortality and morbidity in threatened preterm labor.
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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 | Antenatal steroids administration |
|---|---|
| Sponsor | The Central and Eastern European Gynecologic Oncology Group |
| Drug class | Corticosteroid |
| Target | Glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Obstetrics/Neonatology |
| Phase | Phase 3 |
Mechanism of action
Corticosteroids administered to pregnant women at risk of preterm delivery cross the placenta and stimulate fetal lung development, particularly increasing production of pulmonary surfactant—a critical substance that reduces surface tension in alveoli and enables proper gas exchange. This intervention significantly reduces neonatal mortality, respiratory distress syndrome, and intraventricular hemorrhage in infants born prematurely.
Approved indications
- Prevention of respiratory distress syndrome in preterm infants (gestational age 24–34 weeks at risk of preterm delivery)
- Reduction of neonatal mortality and morbidity in threatened preterm labor
Common side effects
- Maternal hyperglycemia
- Increased infection risk (maternal)
- Hypertension
- Mood changes
Key clinical trials
- Hematological Profiles of Preterm Infants and the Impact of Antenatal Steroids
- TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden (PHASE3)
- Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS (NA)
- To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis (PHASE3)
- Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART) (PHASE3)
- The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes (NA)
- Incidence, Risk Factors and Severity of Retinopathy of Prematurity (ROP) in Turkey
- Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?
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:
- Antenatal steroids administration CI brief — competitive landscape report
- Antenatal steroids administration updates RSS · CI watch RSS
- The Central and Eastern European Gynecologic Oncology Group portfolio CI
Frequently asked questions about Antenatal steroids administration
What is Antenatal steroids administration?
How does Antenatal steroids administration work?
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What drug class is Antenatal steroids administration in?
What development phase is Antenatal steroids administration in?
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What does Antenatal steroids administration target?
Related
- Drug class: All Corticosteroid drugs
- Target: All drugs targeting Glucocorticoid receptor
- Manufacturer: The Central and Eastern European Gynecologic Oncology Group — full pipeline
- Therapeutic area: All drugs in Obstetrics/Neonatology
- Indication: Drugs for Prevention of respiratory distress syndrome in preterm infants (gestational age 24–34 weeks at risk of preterm delivery)
- Indication: Drugs for Reduction of neonatal mortality and morbidity in threatened preterm labor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing