Last reviewed 2026-05-23 · How we verify

silevertinib in combination with temozolomide

Black Diamond Therapeutics, Inc. · Phase 2 active Small molecule ✓ Verified May 2026

silevertinib in combination with temozolomide is a Small molecule drug developed by Black Diamond Therapeutics, Inc.. It is currently in Phase 2 development. Also known as: BDTX-1535, Temodar, TMZ.

Silevertinib in combination with temozolomide is being studied as a treatment for glioblastoma, specifically newly diagnosed glioblastoma with unmethylated MGMT and EGFRvIII. Silevertinib is a small molecule DNA inhibitor that targets DNA.

Likelihood of approval

15.3% 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).

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	silevertinib in combination with temozolomide
Also known as	BDTX-1535, Temodar, TMZ
Sponsor	Black Diamond Therapeutics, Inc.
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII (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:

silevertinib in combination with temozolomide CI brief — competitive landscape report
silevertinib in combination with temozolomide updates RSS · CI watch RSS
Black Diamond Therapeutics, Inc. portfolio CI

Frequently asked questions about silevertinib in combination with temozolomide

What is silevertinib in combination with temozolomide?

silevertinib in combination with temozolomide is a Small molecule drug developed by Black Diamond Therapeutics, Inc..

Who makes silevertinib in combination with temozolomide?

silevertinib in combination with temozolomide is developed by Black Diamond Therapeutics, Inc. (see full Black Diamond Therapeutics, Inc. pipeline at /company/black-diamond-therapeutics-inc).

Is silevertinib in combination with temozolomide also known as anything else?

silevertinib in combination with temozolomide is also known as BDTX-1535, Temodar, TMZ.

What development phase is silevertinib in combination with temozolomide in?

silevertinib in combination with temozolomide is in Phase 2.

Manufacturer: Black Diamond Therapeutics, Inc. — full pipeline
Also known as: BDTX-1535, Temodar, TMZ

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