Last reviewed 2026-06-01 · How we verify

Pediatrix

American SIDS Institute · Phase 1 active Biologic ✓ Verified Jun 2026

Pediatrix is a Biologic drug developed by American SIDS Institute. It is currently in Phase 1 development.

Pediatrix is an intervention used in a clinical study to investigate prolonged apnea and prolonged bradycardia in preterm infants. This study, titled "Prolonged Apnea and Prolonged Bradycardia Following DTaP Immunization in Preterm Infants," is registered on ClinicalTrials.gov with the identifier NCT00482781.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	Pediatrix
Sponsor	American SIDS Institute
Modality	Biologic
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

DTaP and Apnea/Bradycardia in Preterm Infants (NA)

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:

Pediatrix CI brief — competitive landscape report
Pediatrix updates RSS · CI watch RSS
American SIDS Institute portfolio CI

Frequently asked questions about Pediatrix

What is Pediatrix?

Pediatrix is a Biologic drug developed by American SIDS Institute.

Who makes Pediatrix?

Pediatrix is developed by American SIDS Institute (see full American SIDS Institute pipeline at /company/american-sids-institute).

What development phase is Pediatrix in?

Pediatrix is in Phase 1.

Manufacturer: American SIDS Institute — full pipeline
Therapeutic area: All drugs in Other

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing