Last reviewed 2026-05-23 · How we verify

TEDISAMIL

Phase 3 active Small molecule Under review Quality 0/100

TEDISAMIL is a tedisamil drug. It is currently in Phase 3 development.

Tedisamil works by blocking certain potassium channels in the heart, which helps to regulate the heartbeat and prevent abnormal rhythms.

Tedisamil is a small molecule that blocks voltage-gated potassium channels. It has been studied in clinical trials for the rapid conversion of atrial fibrillation or flutter to normal sinus rhythm in male subjects.

Likelihood of approval

56.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	TEDISAMIL
Drug class	tedisamil
Target	Potassium voltage-gated channel subfamily A member 7
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 3

Mechanism of action

Think of the heart as a muscle that needs to beat at a steady pace. Potassium channels help control how fast the heart beats. Tedisamil blocks these channels, which helps to slow down the heart rate and prevent it from beating too quickly or irregularly.

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.

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:

TEDISAMIL CI brief — competitive landscape report
TEDISAMIL updates RSS · CI watch RSS

Frequently asked questions about TEDISAMIL

What is TEDISAMIL?

TEDISAMIL is a tedisamil drug.

How does TEDISAMIL work?

Tedisamil works by blocking certain potassium channels in the heart, which helps to regulate the heartbeat and prevent abnormal rhythms.

What drug class is TEDISAMIL in?

TEDISAMIL belongs to the tedisamil class. See all tedisamil drugs at /class/tedisamil.

What development phase is TEDISAMIL in?

TEDISAMIL is in Phase 3.

What does TEDISAMIL target?

TEDISAMIL targets Potassium voltage-gated channel subfamily A member 7 and is a tedisamil.

Drug class: All tedisamil drugs
Target: All drugs targeting Potassium voltage-gated channel subfamily A member 7
Therapeutic area: All drugs in Cardiovascular

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