Last reviewed 2026-04-20 · How we verify

Steboronine (borofalan (10B))

Stella Pharma · FDA-approved active Quality 13/100

Steboronine (generic name: borofalan (10B)) is a drug developed by Stella Pharma. It is currently FDA-approved for Neoplasm of head and neck.

Borofalan (Steboronine), marketed by Stella Pharma, is a targeted radiotherapeutic agent indicated for neoplasms of the head and neck, with a key composition patent expiring in 2028. Its unique mechanism of delivering a radioactive isotope of boron directly to cancer cells provides a precise and potent treatment option, distinguishing it from off-patent competitors like melphalan. The primary risk is the limited revenue data and the presence of generic alternatives, which may impact market share and profitability.

At a glance

Generic name	borofalan (10B)
Sponsor	Stella Pharma
Therapeutic area	Oncology
Phase	FDA-approved

Approved indications

Neoplasm of head and neck

Common side effects

No common side effects on file.

Key clinical trials

A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors (PHASE1,PHASE2)
Dose Optimized BNCT for Head and Neck Cancer (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:

Steboronine CI brief — competitive landscape report
Steboronine updates RSS · CI watch RSS
Stella Pharma portfolio CI

Frequently asked questions about Steboronine

What is Steboronine?

Steboronine (borofalan (10B)) is a pharmaceutical drug developed by Stella Pharma, indicated for Neoplasm of head and neck.

What is Steboronine used for?

Steboronine is indicated for Neoplasm of head and neck.

Who makes Steboronine?

Steboronine is developed and marketed by Stella Pharma (see full Stella Pharma pipeline at /company/stella-pharma).

What is the generic name of Steboronine?

borofalan (10B) is the generic (nonproprietary) name of Steboronine.

What development phase is Steboronine in?

Steboronine is FDA-approved (marketed).

Manufacturer: Stella Pharma — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Neoplasm of head and neck

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