BI 690517 formulation 2

Boehringer Ingelheim · Phase 1 active Small molecule Quality 0/100

BI 690517 formulation 2 is a Small molecule drug developed by Boehringer Ingelheim. It is currently in Phase 1 development. Also known as: Vicadrostat.

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	BI 690517 formulation 2
Also known as	Vicadrostat
Sponsor	Boehringer Ingelheim
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• A Study in Healthy People to Test How 2 Different Formulations of BI 690517 Are Taken up in the Body and How Probenecid Influences the Amount of BI 690517 in the Blood (PHASE1)

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:

• BI 690517 formulation 2 CI brief — competitive landscape report
• BI 690517 formulation 2 updates RSS · CI watch RSS
• Boehringer Ingelheim portfolio CI

Frequently asked questions about BI 690517 formulation 2

What is BI 690517 formulation 2?

BI 690517 formulation 2 is a Small molecule drug developed by Boehringer Ingelheim.

Who makes BI 690517 formulation 2?

BI 690517 formulation 2 is developed by Boehringer Ingelheim (see full Boehringer Ingelheim pipeline at /company/boehringer-ingelheim).

Is BI 690517 formulation 2 also known as anything else?

BI 690517 formulation 2 is also known as Vicadrostat.

What development phase is BI 690517 formulation 2 in?

BI 690517 formulation 2 is in Phase 1.

Related

• Manufacturer: Boehringer Ingelheim — full pipeline
• Also known as: Vicadrostat