Last reviewed 2026-05-31 · How we verify

BAY1841788

Bayer · Phase 1 active Small molecule ✓ Verified May 2026 Quality 15/100

BAY1841788 is a Small molecule drug developed by Bayer. It is currently in Phase 1 development.

BAY1841788, also known as Darolutamide, is being studied in clinical trials for the treatment of metastatic hormone-sensitive prostate cancer. It is also being investigated in combination with androgen deprivation therapy (ADT) in these trials.

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
Bayer 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	BAY1841788
Sponsor	Bayer
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Fatigue
Arthralgia
Anaemia
Alopecia
Back pain
Constipation
Diarrhoea
Hot flush
Oedema peripheral
Pain in extremity
Hypertension
Nausea

Competitive intelligence

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

BAY1841788 CI brief — competitive landscape report
BAY1841788 updates RSS · CI watch RSS
Bayer portfolio CI

Frequently asked questions about BAY1841788

What is BAY1841788?

BAY1841788 is a Small molecule drug developed by Bayer.

Who makes BAY1841788?

BAY1841788 is developed by Bayer (see full Bayer pipeline at /company/bayer).

What development phase is BAY1841788 in?

BAY1841788 is in Phase 1.

What are the side effects of BAY1841788?

Common side effects of BAY1841788 include Fatigue, Arthralgia, Anaemia, Alopecia, Back pain, Constipation.

Manufacturer: Bayer — full pipeline

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