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Levothyroxine Oral Tablet [Synthroid]

AHS Cancer Control Alberta · Phase 2 active Small molecule

Levothyroxine Oral Tablet [Synthroid] is a Small molecule drug developed by AHS Cancer Control Alberta. It is currently in Phase 2 development.

Likelihood of approval
15.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 2 → approval rate +15.3pp
    Industry-wide phase 2 drugs reach approval ~15.3% 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 2031–2034 —
EMA EU 2032–2035 +0.7 yr
MHRA GB 2032–2035 +0.7 yr
Health Canada CA 2032–2036 +0.9 yr
TGA AU 2032–2036 +1.2 yr
PMDA JP 2032–2036 +1.5 yr
NMPA CN 2033–2037 +2.3 yr
MFDS KR 2032–2036 +1.4 yr
CDSCO IN 2032–2037 +1.8 yr
ANVISA BR 2033–2037 +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 nameLevothyroxine Oral Tablet [Synthroid]
SponsorAHS Cancer Control Alberta
ModalitySmall molecule
PhasePhase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

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 Levothyroxine Oral Tablet [Synthroid]

What is Levothyroxine Oral Tablet [Synthroid]?

Levothyroxine Oral Tablet [Synthroid] is a Small molecule drug developed by AHS Cancer Control Alberta.

Who makes Levothyroxine Oral Tablet [Synthroid]?

Levothyroxine Oral Tablet [Synthroid] is developed by AHS Cancer Control Alberta (see full AHS Cancer Control Alberta pipeline at /company/ahs-cancer-control-alberta).

What development phase is Levothyroxine Oral Tablet [Synthroid] in?

Levothyroxine Oral Tablet [Synthroid] is in Phase 2.

Related

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