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 |
|---|---|---|---|
| pituitary acth hypersecretion | EFO_1001110 | D047748 | E24.0 |
| cushing syndrome | EFO_0003099 | D003480 | E24 |
| acromegaly | — | D000172 | — |
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
82 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 |
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | 3 | 3 | 3 | 1 | 10 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | 5 | 2 | — | 2 | — | 9 |
| Pituitary neoplasms | D010911 | — | — | — | 5 | 1 | 1 | — | 6 |
| Pituitary diseases | D010900 | — | E23.7 | — | 5 | 1 | 1 | — | 6 |
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | 1 | 2 | — | 2 | 1 | 6 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 2 | 1 | 1 | 1 | — | 5 |
| 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 |
| Prolactinoma | D015175 | HP_0006767 | — | — | 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 |
Show 38 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | — | — | — | 1 |
| Intestinal neoplasms | D007414 | — | C26.0 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | 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 |
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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) |
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Safety
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2,045 adverse events reported
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