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
Therapeutic Areas
Trade Name
FDA
EMA
Signifor
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| signifor | New Drug Application | 2024-07-16 |
| signifor lar | New Drug Application | 2024-07-16 |
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
84 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 | 2 | 12 |
| Acth-secreting pituitary adenoma | D049913 | — | — | — | 4 | 3 | 3 | 1 | 11 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 5 | 2 | 2 | 2 | — | 11 |
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | 3 | 3 | 3 | 1 | 10 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 1 | 2 | 1 | — | 6 |
| Pituitary neoplasms | D010911 | — | — | — | 5 | 1 | 1 | — | 6 |
| Pituitary diseases | D010900 | — | E23.7 | — | 5 | 1 | 1 | — | 6 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | 2 | — | 2 | 1 | 6 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 2 | — | 1 | — | 4 |
| Melanoma | D008545 | — | — | 1 | 1 | — | 1 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoid tumor | D002276 | — | D3A.00 | 2 | 2 | 1 | — | — | 5 |
| Adenoma | D000236 | — | — | — | 3 | 1 | — | — | 3 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | 1 | — | — | 2 |
| Intestinal neoplasms | D007414 | — | C26.0 | 1 | — | 1 | — | — | 2 |
| Prolactinoma | D015175 | — | — | — | 2 | 1 | — | — | 2 |
| Cysts | D003560 | — | — | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 1 | 4 | — | — | — | 5 |
| Neoplasms | D009369 | — | C80 | 1 | 4 | — | — | — | 5 |
| Syndrome | D013577 | — | — | — | 4 | — | — | — | 4 |
| Congenital hyperinsulinism | D044903 | — | — | 1 | 1 | — | — | 1 | 3 |
| Nesidioblastosis | D046768 | EFO_0007318 | E16.9 | 1 | 1 | — | — | 1 | 3 |
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | 3 | — | — | — | 3 |
| Multiple myeloma | D009101 | — | C90.0 | — | 2 | — | — | — | 2 |
| Plasma cell neoplasms | D054219 | — | — | — | 2 | — | — | — | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | 1 | — | — | — | 2 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 2 | — | — | — | 2 |
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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 | — | N19 | 1 | — | — | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 1 | — | — | — | — | 1 |
| Digestive system neoplasms | D004067 | — | — | 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 |
| Lobular carcinoma | D018275 | EFO_0000570 | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative complications | D011183 | — | — | — | — | — | — | 1 | 1 |
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 | — |
| ChEMBL ID | CHEMBL3039583 |
| ChEBI ID | — |
| PubChem CID | 9941444 |
| DrugBank | DB06663 |
| UNII ID | 98H1T17066 (ChemIDplus, GSRS) |
Target
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Safety
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2,438 adverse events reported
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