Protamine sulfate
Protamine (protamine sulfate) is a protein pharmaceutical. Protamine sulfate was first approved as Protamine sulfate on 1982-01-01.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Protamine (discontinued: Protamine)
Drug Products
FDA
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Protamine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROTAMINE SULFATE | Eli Lilly | N-006460 DISCN | 1982-01-01 | 2 products, RLD |
| PROTAMINE SULFATE | Pharmacia & Upjohn | N-007413 DISCN | 1982-01-01 | 2 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| .insulin aspart protamine and insulin aspart | Biologic Licensing Application | 2024-02-22 |
| .insulin aspart protamine and insulin aspart insulin aspart protamine and insulin aspart | Biologic Licensing Application | 2019-11-15 |
| insulin aspart protamine and insulin aspart | Biologic Licensing Application | 2025-07-18 |
| insulin lispro protamine and insulin lispro injectable suspension | Biologic Licensing Application | 2024-08-06 |
| protamine sulfate | ANDA | 2025-04-29 |
Indications
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Agency Specific
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Clinical
Clinical Trials
263 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 7 | 6 | 37 | 55 | 41 | 145 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 21 | 4 | 35 | 39 | 41 | 140 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 9 | — | 10 | 1 | 13 | 33 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | 3 | 4 | 7 | 5 | 19 |
| Cardiac surgical procedures | D006348 | — | — | — | — | 1 | 4 | 9 | 14 |
| Hemostatic disorders | D020141 | — | — | — | 1 | — | 2 | 7 | 10 |
| Blood coagulation disorders | D001778 | EFO_0009314 | D68.9 | — | — | — | 3 | 6 | 9 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 2 | 2 | 2 | 3 | 9 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | 1 | 4 | 2 | 7 |
| Cardiopulmonary bypass | D002315 | — | — | — | — | 1 | 1 | 4 | 6 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | — | 2 | 3 |
| Coronary artery bypass | D001026 | EFO_0003776 | — | — | — | 2 | — | 1 | 3 |
| Aortic dissection | D000784 | — | I71.0 | — | 1 | 1 | — | 1 | 2 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | 1 | — | — | 1 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 1 | — | — | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | 1 | — | — | 1 |
| Obstructive lung diseases | D008173 | — | — | — | — | 1 | — | — | 1 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | 1 | — | — | 1 |
| Seizures | D012640 | — | G40.4 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 1 | 2 | — | — | — | 2 |
| Congenital heart defects | D006330 | — | Q24.9 | — | 1 | — | — | 1 | 2 |
| Immunotherapy | D007167 | — | — | — | 1 | — | — | — | 1 |
| Postoperative complications | D011183 | — | — | — | 1 | — | — | — | 1 |
| Acute lung injury | D055371 | EFO_0004610 | — | — | 1 | — | — | — | 1 |
| Lung injury | D055370 | — | S27.30 | — | 1 | — | — | — | 1 |
| Transfusion-related acute lung injury | D000073617 | — | J95.84 | — | 1 | — | — | — | 1 |
| Transfusion reaction | D065227 | — | D69.51 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | — | 8 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | — | — | — | 1 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | 1 | — | — | — | — | 1 |
| Heart rate | D006339 | EFO_0004326 | — | 1 | — | — | — | — | 1 |
| Air pressure | D000399 | — | — | 1 | — | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coagulation protein disorders | D020147 | — | — | — | — | — | — | 4 | 4 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | — | — | — | 2 | 2 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | — | — | — | 2 | 2 |
| Latent autoimmune diabetes in adults | D000071698 | — | — | — | — | — | — | 1 | 1 |
| Drug delivery systems | D016503 | — | — | — | — | — | — | 1 | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | — | 1 | 1 |
| Inborn genetic diseases | D030342 | EFO_0000508 | — | — | — | — | — | 1 | 1 |
| Infertility | D007246 | EFO_0000545 | — | — | — | — | — | 1 | 1 |
| Anemia | D000740 | EFO_0004272 | D64.9 | — | — | — | — | 1 | 1 |
| Extracorporeal membrane oxygenation | D015199 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Protamine sulfate |
| INN | protamine sulfate |
| Description | Protamine sulfate is a medication that is used to reverse the effects of heparin. It is specifically used in heparin overdose, in low molecular weight heparin overdose, and to reverse the effects of heparin during delivery and heart surgery. It is given by injection into a vein. The onset of effects is typically within five minutes.
|
| Classification | Protein |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201651 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09141 |
| UNII ID | 0DE9724IHC (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Protamine sulfate
Adverse Events
Top Adverse Reactions
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933 adverse events reported
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