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Drug ReportsPasireotide
Signifor lar kit, Signifor(pasireotide)
Signifor (pasireotide) is a protein pharmaceutical. Pasireotide was first approved as Signifor on 2012-04-24. It is used to treat cushing syndrome in the USA. It has been approved in Europe to treat acromegaly and pituitary acth hypersecretion. The pharmaceutical is active against somatostatin receptor type 3, somatostatin receptor type 1, somatostatin receptor type 2, and somatostatin receptor type 5.
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Drug
Target
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Financial
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5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
endocrine system diseasesD004700
Trade Name
FDA
EMA
Signifor
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Pasireotide pamoate
Tradename
Company
Number
Date
Products
SIGNIFOR LAR KITRecordatiN-203255 RX2014-12-15
5 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
signiforNew Drug Application2025-04-10
signifor larNew Drug Application2024-07-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
cushing syndromeEFO_0003099D003480E24
Agency Specific
FDA
EMA
Expiration
Code
PASIREOTIDE PAMOATE, SIGNIFOR LAR KIT, RECORDATI RARE
2025-06-29ODE-268
Patent Expiration
Patent
Expires
Flag
FDA Information
Pasireotide Pamoate, Signifor Lar Kit, Recordati Rare
93519232028-05-23DP
74737612026-12-14DS, DP
77593082026-10-25DP
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
H01: Pituitary and hypothalamic hormones and analogues
H01C: Hypothalamic hormones
H01CB: Somatostatin and analogues
H01CB05: Pasireotide
HCPCS
Code
Description
J2502
Injection, pasireotide long acting, 1 mg
Clinical
Clinical Trials
85 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AcromegalyD0001721333313
Pituitary acth hypersecretionD047748EFO_1001110E24.0333110
Neuroendocrine tumorsD018358EFO_1001901D3A.8521210
Pituitary neoplasmsD0109116218
Pituitary diseasesD010900E23.75116
Acth-secreting pituitary adenomaD0499132215
Pancreatic neoplasmsD010190EFO_0003860C2521115
HypoglycemiaD007003E16.21315
Prostatic neoplasmsD011471C612214
Dumping syndromeD004377EFO_1001307K91.1213
Show 4 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Carcinoid tumorD002276D3A.002215
AdenomaD000236313
ProlactinomaD015175212
HyperpituitarismD006964EFO_1000973E2211
FistulaD00540211
Follicular lymphomaD008224C8211
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277C80.0145
NeoplasmsD009369C80145
SyndromeD01357744
Congenital hyperinsulinismD0449031113
Cushing syndromeD003480EFO_0003099E2433
Multiple myelomaD009101C90.022
Castration-resistant prostatic neoplasmsD064129112
Thyroid neoplasmsD013964EFO_000384122
Neuroendocrine carcinomaD01827822
Thyroid diseasesD013959E00-E0722
Show 40 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NesidioblastosisD046768EFO_0007318E16.9112
Neoplasm metastasisD009362EFO_000970822
Stomach neoplasmsD013274EFO_0003897C1611
Intestinal neoplasmsD007414C26.011
Healthy volunteers/patients11
Renal insufficiencyD051437N1911
Digestive system neoplasmsD00406711
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A11
Merkel cell carcinomaD015266EFO_1001471C4A11
AdenocarcinomaD00023011
Show 6 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Postoperative complicationsD01118311
Growth hormone-secreting pituitary adenomaD049912EFO_000412511
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePasireotide
INNpasireotide
Description
Pasireotide is a six-membered homodetic cyclic peptide composed from L-phenylglycyl, D-tryptophyl, L-lysyl, O-benzyl-L-tyrosyl, L-phenylalanyl and modified L-hydroxyproline residues joined in sequence. A somatostatin analogue with pharmacologic properties mimicking those of the natural hormone somatostatin; used (as its diaspartate salt) for treatment of Cushing's disease. It has a role as an antineoplastic agent. It is a homodetic cyclic peptide and a peptide hormone. It is a conjugate base of a pasireotide(2+).
Classification
Protein
Drug classpeptides: inhibition of growth hormone release
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NCCCC[C@@H]1NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](c2ccccc2)NC(=O)[C@@H]2C[C@H](OC(=O)NCCN)CN2C(=O)[C@H](Cc2ccccc2)NC(=O)[C@H](Cc2ccc(OCc3ccccc3)cc2)NC1=O
Identifiers
PDB
CAS-ID396091-73-9
RxCUI
ChEMBL IDCHEMBL3039583
ChEBI ID
PubChem CID9941444
DrugBankDB06663
UNII ID98H1T17066 (ChemIDplus, GSRS)
Target
Agency Approved
SSTR5
SSTR5
Organism
Homo sapiens
Gene name
SSTR5
Gene synonyms
NCBI Gene ID
Protein name
somatostatin receptor type 5
Protein synonyms
somatostatin receptor subtype 5
Uniprot ID
Mouse ortholog
Sstr5 (20609)
somatostatin receptor type 5 (Q3UZM7)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,545 adverse events reported
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