Last reviewed 2026-06-02 · How we verify

BIBW 2992 plus TMZ

Boehringer Ingelheim · Phase 2 active Small molecule ✓ Verified Jun 2026 Quality 15/100

BIBW 2992 plus TMZ is a Small molecule drug developed by Boehringer Ingelheim. It is currently in Phase 2 development.

BIBW 2992, also known as Afatinib, is a small molecule used in the treatment of patients with recurrent malignant glioma. It is being studied in combination with TMZ (Temozolomide) for the treatment of this condition.

Likelihood of approval

18.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	BIBW 2992 plus TMZ
Sponsor	Boehringer Ingelheim
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

Constipation
Headache
Convulsion
Thrombocytopenia
Diarrhoea
Urinary tract infection
Weight increased
Aphasia
Hemiparesis
Somnolence
Cough
Rash

Key clinical trials

BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma (PHASE2)

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:

BIBW 2992 plus TMZ CI brief — competitive landscape report
BIBW 2992 plus TMZ updates RSS · CI watch RSS
Boehringer Ingelheim portfolio CI

Frequently asked questions about BIBW 2992 plus TMZ

What is BIBW 2992 plus TMZ?

BIBW 2992 plus TMZ is a Small molecule drug developed by Boehringer Ingelheim.

Who makes BIBW 2992 plus TMZ?

BIBW 2992 plus TMZ is developed by Boehringer Ingelheim (see full Boehringer Ingelheim pipeline at /company/boehringer-ingelheim).

What development phase is BIBW 2992 plus TMZ in?

BIBW 2992 plus TMZ is in Phase 2.

What are the side effects of BIBW 2992 plus TMZ?

Common side effects of BIBW 2992 plus TMZ include Constipation, Headache, Convulsion, Thrombocytopenia, Diarrhoea, Urinary tract infection.

Manufacturer: Boehringer Ingelheim — full pipeline

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