Is Crinetics Pharmaceuticals, Inc. FDA approved?

Crinetics Pharmaceuticals, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Crinetics Pharmaceuticals, Inc. make?

2 products are listed under Crinetics Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Crinetics Pharmaceuticals, Inc.

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

Request a quote Claim this profile

Registered sites: 0
Active NDC listings: 2
Live patents: 18
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
tablet, film coated	2

Route	NDCs
oral	2

Labeller name on the listing	NDCs
crinetics pharmaceuticals, inc.	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10351547	PALSONIFYpaltusotine hydrochloride	substance, product	Jul 2037
10597377	PALSONIFYpaltusotine hydrochloride	substance, product	Jul 2037
10875839	PALSONIFYpaltusotine hydrochloride	use	Jul 2037
11414397	PALSONIFYpaltusotine hydrochloride	substance, product	Jul 2037
9896432	PALSONIFYpaltusotine hydrochloride	substance, product	Jul 2037
10464918	PALSONIFYpaltusotine hydrochloride	substance	Jan 2039
11266641	PALSONIFYpaltusotine hydrochloride	product	Sept 2041
11957674	PALSONIFYpaltusotine hydrochloride	use	Sept 2041
12208092	PALSONIFYpaltusotine hydrochloride	use	Mar 2044

Product	Exclusivity	Until
PALSONIFYPALTUSOTINE HYDROCHLORIDE	ODE-537 Orphan drug	Sept 2032

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
PALSONIFY	PALTUSOTINE	tablet, film coated, oral	84015-920NDA
PALSONIFY	PALTUSOTINE	tablet, film coated, oral	84015-930NDA

Enquiry

Common questions

Is Crinetics Pharmaceuticals, Inc. FDA approved?: Crinetics Pharmaceuticals, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Crinetics Pharmaceuticals, Inc. make?: 2 products are listed under Crinetics Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as tablet, film coated. 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.