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oxbryta

Generic: voxelotor

oxbryta: sourced relationships with 1 company · 2 FDA decisions.

oxbryta evidence translation

What we can confirm

What it means

Source-backed records connect oxbryta to GBT; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could oxbryta → GBT affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Sickle cell disease (SCD)

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
Global Blood Therapeutics, Inc. (GBT)
developer · Reported 2022-02-23 · Current development: unknownSource
Sickle cell disease (SCD)
Approved
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). OXBRYTA is a hemoglobin S polymerization inhibitor indicated for the treatment of sickle (GBT)FDA ↗
NDA216157Type 3 - New Dosage FormOrphan DrugPriorityOralTablet
Approval1 INDICATIONS AND USAGE OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). OXBRYTA is a hemoglobin S polymerization inhibitor indicated for the treatment of sickle (GBT)FDA ↗
NDA213137Type 1 - New Molecular EntityOrphan DrugPriorityOralTablet

Frequently asked questions

Which companies have sourced relationships with oxbryta?

oxbryta has dated SEC/FDA relationship records for Global Blood Therapeutics, Inc..

What is oxbryta's latest FDA decision?

The most recent tracked FDA decision for oxbryta is Approval for 1 INDICATIONS AND USAGE OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). OXBRYTA is a hemoglobin S polymerization inhibitor indicated for the treatment of sickle , dated December 17, 2021.