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

Stem definitionDrug idCAS RN
5784 2172870-89-0

Description:

MoleculeDescription

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:

DateAgencyCompanyOrphan
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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Somatostatin receptor type 2 GPCR AGONIST EC50 9.60 DRUG LABEL DRUG LABEL
Somatostatin receptor type 4 GPCR EC50 6 CHEMBL
Somatostatin receptor type 2 GPCR AGONIST EC50 8.92 IUPHAR

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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