Is Kura Oncology, Inc. FDA approved?

Kura Oncology, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Kura Oncology, Inc. make?

1 product is listed under Kura Oncology, Inc. in the openFDA NDC Directory, most often as capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Kura Oncology, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 1
Live patents: 8
Exclusivities: 1
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10077271	KOMZIFTIziftomenib	substance, product	Mar 2036
10174041	KOMZIFTIziftomenib	use	Mar 2036
10869868	KOMZIFTIziftomenib	use	Jan 2037
10781218	KOMZIFTIziftomenib	substance, product	Mar 2037
11673898	KOMZIFTIziftomenib	use	Mar 2037
11944627	KOMZIFTIziftomenib	use	Sept 2038
12410184	KOMZIFTIziftomenib	substance, product	Jul 2044
12521396	KOMZIFTIziftomenib	product	Jul 2044

Product	Exclusivity	Until
KOMZIFTIZIFTOMENIB	NCE New chemical entity	Nov 2030

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Komzifti	ziftomenib	capsule, oral	84696-200NDA

Enquiry

Common questions

Is Kura Oncology, Inc. FDA approved?: Kura Oncology, Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Kura Oncology, Inc. make?: 1 product is listed under Kura Oncology, Inc. in the openFDA NDC Directory, most often as capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.