All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

paltusotine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
	5784	2172870-89-0

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: paltusotine CRN00808 palsonify paltusotine hydrochloride

Similar to the natural hormone somatostatin (SST), paltusotine demonstrates potent suppression of GH and IGF-1 secretion. Paltusotine exerts its pharmacological activity via highly selective binding (> 4 000-fold) to somatostatin receptor 2 (SST2) and exhibits little or no affinity for other SST receptor subtypes. Paltusotine inhibits cyclic adenosine monophosphate (cAMP) accumulation via human SST2 activation with an average drug (agonist) concentration that results in half-maximal response (EC50) of 0.25 nM. Molecular weight: 456.50 Formula: C27H22F2N4O CLOGP: 5.35 LIPINSKI: 0 HAC: 5 HDO: 2 TPSA: 86.17 ALOGS: ROTB: 3 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

Date	Agency	Company	Orphan
April 23, 2026	EMA	Crinetics Pharmaceuticals Europe GmbH
Sept. 25, 2025	FDA	Crinetics Pharmaceuticals, Inc.

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	H01CB06	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES HYPOTHALAMIC HORMONES Somatostatin and analogues
CHEBI has role	CHEBI:35610	antineoplastic agent

Related Drugs by ATC class:

H01CB Somatostatin and analogues 4 drugs

lanreotideoctreotidepasireotidesomatostatin

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Acromegaly	indication	74107003	DOID:2449

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 20MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	10351547	July 12, 2037	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 20MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	10597377	July 12, 2037	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 20MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	10875839	July 12, 2037	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 20MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	11414397	July 12, 2037	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 20MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	9896432	July 12, 2037	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 30MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	10351547	July 12, 2037	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 30MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	10597377	July 12, 2037	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 30MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	10875839	July 12, 2037	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 30MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	11414397	July 12, 2037	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 30MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	9896432	July 12, 2037	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 20MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	11266641	Sept. 7, 2041	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 20MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	11957674	Sept. 7, 2041	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 30MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	11266641	Sept. 7, 2041	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 30MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	11957674	Sept. 7, 2041	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 20MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	12208092	March 25, 2044	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAVE HEPATIC IMPAIRMENT AND AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 30MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	12208092	March 25, 2044	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAVE HEPATIC IMPAIRMENT AND AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 20MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	Sept. 25, 2030	NEW CHEMICAL ENTITY
EQ 30MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	Sept. 25, 2030	NEW CHEMICAL ENTITY
EQ 20MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	Sept. 25, 2032	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
EQ 30MG BASE	PALSONIFY	CRINETICS	N219070	Sept. 25, 2025	RX	TABLET	ORAL	Sept. 25, 2032	TREATMENT OF ADULTS WITH ACROMEGALY WHO HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Somatostatin receptor type 2	GPCR	P30874	SSR2_HUMAN	AGONIST	EC50	9.60		DRUG LABEL	DRUG LABEL
Somatostatin receptor type 4	GPCR	P31391	SSR4_HUMAN		EC50	6		CHEMBL
Somatostatin receptor type 2	GPCR		SSR2_RAT	AGONIST	EC50	8.92		IUPHAR

External reference:

ID	Source
IUD	PDB_CHEM_ID
CHEMBL5267842	ChEMBL_ID
C000731874	MESH_SUPPLEMENTAL_RECORD_UI
DB16277	DRUGBANK_ID
4044288	VANDF
C5432234	UMLSCUI
CHEBI:759077	CHEBI
CHEMBL5314560	ChEMBL_ID
11101	INN_ID
D12477	KEGG_DRUG
2361216-83-1	SECONDARY_CAS_RN
134168328	PUBCHEM_CID
398083	MMSL
44441	MMSL
d10322	MMSL
020255	NDDF
020256	NDDF
14237	IUPHAR_LIGAND_ID
F2IBD1GMD3	UNII
2724363	RXNORM

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
PALSONIFY	HUMAN PRESCRIPTION DRUG LABEL	1	84015-920	TABLET, FILM COATED	20 mg	ORAL	NDA	28 sections
PALSONIFY	HUMAN PRESCRIPTION DRUG LABEL	1	84015-930	TABLET, FILM COATED	30 mg	ORAL	NDA	28 sections