Last reviewed 2026-05-22 · How we verify

Volasertib, high dose, d1q3w

Boehringer Ingelheim · Phase 1 active Small molecule ✓ Verified May 2026 Quality 20/100

Volasertib, high dose, d1q3w is a Small molecule drug developed by Boehringer Ingelheim. It is currently in Phase 1 development.

Volasertib is a small molecule used to treat various types of neoplasms. It is administered intravenously at a high dose once every three weeks (d1q3w) as part of a Phase I trial.

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	Volasertib, high dose, d1q3w
Sponsor	Boehringer Ingelheim
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Leukopenia
Neutropenia
Thrombocytopenia
Constipation
Diarrhoea
Fatigue
Injection site reaction
Pyrexia
Cystitis
Contusion
Electrocardiogram QT prolonged
Periarthritis

Key clinical trials

BI 6727 (Volasertib) Monotherapy Phase I Trial in Japanese Patients With Advanced Solid Tumours (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:

Volasertib, high dose, d1q3w CI brief — competitive landscape report
Volasertib, high dose, d1q3w updates RSS · CI watch RSS
Boehringer Ingelheim portfolio CI

Frequently asked questions about Volasertib, high dose, d1q3w

What is Volasertib, high dose, d1q3w?

Volasertib, high dose, d1q3w is a Small molecule drug developed by Boehringer Ingelheim.

Who makes Volasertib, high dose, d1q3w?

Volasertib, high dose, d1q3w is developed by Boehringer Ingelheim (see full Boehringer Ingelheim pipeline at /company/boehringer-ingelheim).

What development phase is Volasertib, high dose, d1q3w in?

Volasertib, high dose, d1q3w is in Phase 1.

What are the side effects of Volasertib, high dose, d1q3w?

Common side effects of Volasertib, high dose, d1q3w include Leukopenia, Neutropenia, Thrombocytopenia, Constipation, Diarrhoea, Fatigue.

Manufacturer: Boehringer Ingelheim — full pipeline

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