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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Commercial
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 KIT | Recordati | N-203255 RX | 2014-12-15 | 5 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| signifor | New Drug Application | 2023-03-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cushing syndrome | EFO_0003099 | D003480 | E24 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PASIREOTIDE PAMOATE, SIGNIFOR LAR KIT, RECORDATI RARE | |||
| 2025-06-29 | ODE-268 | ||
HCPCS
Code | Description |
|---|---|
| J2502 | Injection, pasireotide long acting, 1 mg |
Clinical
Clinical Trials
78 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acromegaly | D000172 | 1 | 3 | 3 | 3 | 1 | 11 | ||
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | 3 | 3 | 3 | 1 | 10 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 5 | 1 | — | 2 | — | 8 |
| Pituitary neoplasms | D010911 | — | 4 | 1 | 1 | — | 5 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | 1 | 1 | — | 4 |
| Prostatic neoplasms | D011471 | C61 | 1 | 2 | — | 1 | — | 3 | |
| Dumping syndrome | D004377 | EFO_1001307 | K91.1 | — | 2 | — | 1 | — | 3 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | — | — | — | 2 | — | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
| Melanoma | D008545 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prolactinoma | D015175 | HP_0006767 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoid tumor | D002276 | D3A.00 | 2 | 2 | — | — | — | 4 | |
| Congenital hyperinsulinism | D044903 | 1 | 1 | — | — | 1 | 3 | ||
| Multiple myeloma | D009101 | C90.0 | — | 2 | — | — | — | 2 | |
| Castration-resistant prostatic neoplasms | D064129 | 1 | 1 | — | — | — | 2 | ||
| Ectopic acth syndrome | D000182 | EFO_1001256 | E24.3 | — | 2 | — | — | — | 2 |
| Nelson syndrome | D009347 | E24.1 | — | 2 | — | — | — | 2 | |
| Papillary thyroid cancer | D000077273 | — | 1 | — | — | — | 1 | ||
| Neuroendocrine carcinoma | D018278 | — | 1 | — | — | — | 1 | ||
| Hepatocellular carcinoma | D006528 | C22.0 | — | 1 | — | — | — | 1 | |
| Islet cell adenoma | D007516 | EFO_0007331 | D13.7 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 1 | — | — | — | — | 1 |
| Merkel cell carcinoma | D015266 | EFO_1001471 | C4A | 1 | — | — | — | — | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | — | — | — | — | 1 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 1 | — | — | — | — | 1 |
| Breast carcinoma in situ | D000071960 | D05 | 1 | — | — | — | — | 1 | |
| Phenylketonurias | D010661 | E70.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | PASIREOTIDE |
| INN | pasireotide |
| 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 class | peptides: inhibition of growth hormone release |
| Image (chem structure or protein) | |
| 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-ID | 396091-73-9 |
| RxCUI | 1364105 |
| ChEMBL ID | CHEMBL3039583 |
| ChEBI ID | — |
| PubChem CID | 9941444 |
| DrugBank | DB06663 |
| UNII ID | 98H1T17066 (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,672 adverse events reported
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