Last reviewed 2026-05-18 · How we verify

Dexlansoprazole Delayed Release Capsules

Takeda · Phase 1 active Small molecule Quality 60/100

Dexlansoprazole Delayed Release Capsules is a Proton Pump Inhibitor Small molecule drug developed by Takeda. It is currently in Phase 1 development. Also known as: Dexilant.

Blocks the H+/K+ ATPase enzyme system (proton pump) in gastric parietal cells, suppressing gastric acid secretion.

Likelihood of approval

12.6% 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).
Big-pharma sponsor +3.0pp
Takeda is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	Dexlansoprazole Delayed Release Capsules
Also known as	Dexilant
Sponsor	Takeda
Drug class	Proton Pump Inhibitor
Modality	Small molecule
Phase	Phase 1

Mechanism of action

Dexlansoprazole is the R-enantiomer of lansoprazole. It inhibits the final step of gastric acid production by binding to and blocking the proton pump in the stomach lining. The dual delayed-release formulation releases medication at two different pH levels, providing prolonged acid suppression throughout the day.

Approved indications

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:

Dexlansoprazole Delayed Release Capsules CI brief — competitive landscape report
Dexlansoprazole Delayed Release Capsules updates RSS · CI watch RSS
Takeda portfolio CI

Frequently asked questions about Dexlansoprazole Delayed Release Capsules

What is Dexlansoprazole Delayed Release Capsules?

Dexlansoprazole Delayed Release Capsules is a Proton Pump Inhibitor drug developed by Takeda.

How does Dexlansoprazole Delayed Release Capsules work?

Blocks the H+/K+ ATPase enzyme system (proton pump) in gastric parietal cells, suppressing gastric acid secretion.

Who makes Dexlansoprazole Delayed Release Capsules?

Dexlansoprazole Delayed Release Capsules is developed by Takeda (see full Takeda pipeline at /company/takeda).

Is Dexlansoprazole Delayed Release Capsules also known as anything else?

Dexlansoprazole Delayed Release Capsules is also known as Dexilant.

What drug class is Dexlansoprazole Delayed Release Capsules in?

Dexlansoprazole Delayed Release Capsules belongs to the Proton Pump Inhibitor class. See all Proton Pump Inhibitor drugs at /class/proton-pump-inhibitor.

What development phase is Dexlansoprazole Delayed Release Capsules in?

Dexlansoprazole Delayed Release Capsules is in Phase 1.

Drug class: All Proton Pump Inhibitor drugs
Manufacturer: Takeda — full pipeline
Also known as: Dexilant

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