Sandostatin, Mycapssa(octreotide)
Mycapssa, Sandostatin (octreotide) is a protein pharmaceutical. Octreotide was first approved as Sandostatin on 1988-10-21. It is used to treat acromegaly, adenoma, diarrhea, pancreatic neoplasms, and pituitary neoplasms in the USA. It has been approved in Europe to treat acromegaly. The pharmaceutical is active against somatostatin receptor type 2. In addition, it is known to target somatostatin receptor type 3 and somatostatin receptor type 5.
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Commercial
Trade Name
FDA
EMA
Bynfezia, Mycapssa, Octreotide, Sandostatin (discontinued: Octreotide, Sandostatin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Octreotide acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MYCAPSSA | Chiesi Farmaceutici | N-208232 RX | 2020-06-26 | 1 products, RLD, RS |
| SANDOSTATIN | Novartis | N-019667 RX | 1988-10-21 | 3 products, RLD, RS |
| SANDOSTATIN LAR | Novartis | N-021008 RX | 1998-11-25 | 3 products, RLD, RS |
| BYNFEZIA PEN | Sun Pharmaceutical Industries | N-213224 RX | 2024-09-27 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bynfezia pen | New Drug Application | 2025-02-21 |
| mycapssa | New Drug Application | 2025-07-24 |
| octreotide | ANDA | 2024-05-23 |
| octreotide acetate | ANDA | 2025-07-01 |
| octreotide octreotide | ANDA | 2019-09-12 |
| sandostatin | New Drug Application | 2025-08-11 |
| sandostatin lar depot | New Drug Application | 2025-08-11 |
| sandostatin lar depot sandostatin lar depot demonstration | New Drug Application | 2014-05-19 |
| sandostatin lar depot sandostatin lar depot demonstration kit | New Drug Application | 2016-07-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| pancreatic neoplasms | EFO_0003860 | D010190 | C25 |
| diarrhea | — | D003967 | R19.7 |
| pituitary neoplasms | — | D010911 | — |
| adenoma | — | D000236 | — |
| acromegaly | — | D000172 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
OCTREOTIDE ACETATE, MYCAPSSA, AMRYT | |||
| 2023-06-26 | NP | ||
Patent Expiration
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
— H01CB02: Octreotide
V: Various drug classes in atc
— V09: Diagnostic radiopharmaceuticals
— V09I: Tumour detection radiopharmaceuticals
— V09IA: Technetium (99mtc) compounds
— V09IA07: Technetium (99mtc) hynic-octreotide
Clinical
Clinical Trials
314 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 | — | — | — | 3 | 5 | 9 | — | 17 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | 2 | — | 4 |
| Diarrhea | D003967 | — | R19.7 | — | 1 | 2 | 1 | — | 4 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | 2 | — | 3 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | — | — | 1 | — | 1 |
| Pituitary neoplasms | D010911 | — | — | — | — | — | 1 | — | 1 |
| Sexual infantilism | D050035 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoid tumor | D002276 | — | D3A.00 | 1 | 2 | 2 | — | — | 5 |
| Carcinoma | D002277 | — | C80.0 | — | 3 | 2 | — | — | 5 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | — | 5 | — | — | 5 |
| Malignant carcinoid syndrome | D008303 | — | E34.0 | 1 | 1 | 1 | — | — | 3 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 2 | 1 | — | — | 2 |
| Autosomal dominant polycystic kidney | D016891 | EFO_1001496 | Q61.2 | — | 2 | 1 | — | — | 2 |
| Serotonin syndrome | D020230 | EFO_1001842 | G90.81 | — | 1 | 1 | — | — | 2 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | 2 | — | — | 2 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 2 | — | — | 2 |
| Retinal diseases | D012164 | — | H35.9 | — | — | 2 | — | — | 2 |
Show 11 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | 3 | — | — | 1 | 4 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 2 | — | — | — | 3 |
| Neuroendocrine carcinoma | D018278 | — | — | — | 3 | — | — | — | 3 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 1 | — | — | — | 2 |
| Islet cell carcinoma | D018273 | — | C25.4 | — | 2 | — | — | — | 2 |
| Congenital hyperinsulinism | D044903 | — | — | 1 | 1 | — | — | — | 2 |
| Nesidioblastosis | D046768 | EFO_0007318 | E16.9 | 1 | 1 | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | — | 2 | — | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Hyperinsulinism | D006946 | — | E16.1 | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 1 | — | — | — | 1 | 2 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 1 | — | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | — | — | — | — | 1 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Paraneoplastic syndromes | D010257 | — | — | 1 | — | — | — | — | 1 |
| Nervous system neoplasms | D009423 | — | — | 1 | — | — | — | — | 1 |
| Islet cell adenoma | D007516 | EFO_0007331 | D13.7 | 1 | — | — | — | — | 1 |
| Hypoglycemia | D007003 | — | E16.2 | 1 | — | — | — | — | 1 |
| Hemorrhage | D006470 | MP_0001914 | R58 | 1 | — | — | — | — | 1 |
Show 3 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prader-willi syndrome | D011218 | Orphanet_739 | Q87.11 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Octreotide |
| INN | octreotide |
| Description | Octreotide, sold under the brand name Sandostatin among others, is an octapeptide that mimics natural somatostatin pharmacologically, though it is a more potent inhibitor of growth hormone, glucagon, and insulin than the natural hormone. It was first synthesized in 1979 by the chemist Wilfried Bauer, and binds predominantly to the somatostatin receptors SSTR2 and SSTR5.
|
| Classification | Protein |
| Drug class | peptides: inhibition of growth hormone release |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@@H](O)[C@@H]1NC(=O)[C@H](CCCCN)NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](Cc2ccccc2)NC(=O)[C@@H](NC(=O)[C@H](N)Cc2ccccc2)CSSC[C@@H](C(=O)N[C@H](CO)[C@@H](C)O)NC1=O |
Identifiers
| PDB | — |
| CAS-ID | 83150-76-9 |
| RxCUI | 7617 |
| ChEMBL ID | CHEMBL1680 |
| ChEBI ID | — |
| PubChem CID | 448601 |
| DrugBank | DB00104 |
| UNII ID | RWM8CCW8GP (ChemIDplus, GSRS) |
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Mycapssa – Amryt Pharma
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Sandostatin – Novartis
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Octreotide
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Safety
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36,173 adverse events reported
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