Last reviewed 2026-04-20 · How we verify

Dabigatran etexilate pellets

Boehringer Ingelheim · Phase 1 active Small molecule Quality 5/100

Dabigatran etexilate pellets is a Small molecule drug developed by Boehringer Ingelheim. It is currently in Phase 1 development.

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
Boehringer Ingelheim 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	Dabigatran etexilate pellets
Sponsor	Boehringer Ingelheim
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Headache
Nasopharyngitis
Vomiting
Pyrexia
Dyspepsia
Diarrhoea
Epistaxis
Nausea
Upper respiratory tract infection
Cough
Abdominal pain upper
Pain in extremity

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Dabigatran etexilate pellets CI brief — competitive landscape report
Dabigatran etexilate pellets updates RSS · CI watch RSS
Boehringer Ingelheim portfolio CI

Frequently asked questions about Dabigatran etexilate pellets

What is Dabigatran etexilate pellets?

Dabigatran etexilate pellets is a Small molecule drug developed by Boehringer Ingelheim.

Who makes Dabigatran etexilate pellets?

Dabigatran etexilate pellets is developed by Boehringer Ingelheim (see full Boehringer Ingelheim pipeline at /company/boehringer-ingelheim).

What development phase is Dabigatran etexilate pellets in?

Dabigatran etexilate pellets is in Phase 1.

What are the side effects of Dabigatran etexilate pellets?

Common side effects of Dabigatran etexilate pellets include Headache, Nasopharyngitis, Vomiting, Pyrexia, Dyspepsia, Diarrhoea.

Manufacturer: Boehringer Ingelheim — full pipeline

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