Last reviewed · How we verify

Tocolytics

Chulalongkorn University · Phase 1 active Small molecule ✓ Verified May 2026

Tocolytics is a Small molecule drug developed by Chulalongkorn University. It is currently in Phase 1 development.

Tocolytics are medications used to suppress premature labor, with the goal of postponing delivery long enough for the administration of glucocorticoids to be effective. These medications are typically used when delivery would result in premature birth, which accounts for 70% of neonatal deaths.

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 nameTocolytics
SponsorChulalongkorn University
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Tocolytics

What is Tocolytics?

Tocolytics is a Small molecule drug developed by Chulalongkorn University.

Who makes Tocolytics?

Tocolytics is developed by Chulalongkorn University (see full Chulalongkorn University pipeline at /company/chulalongkorn-university).

What development phase is Tocolytics in?

Tocolytics is in Phase 1.

Related

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