Enoxaparin sodium
Highest phase reached
Approved
Drug type
Oligosaccharide
First approval year
1993
- First approval year
- 1993
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Oligosaccharide
- Drug name
- Enoxaparin sodium
- clexane
- Clexane
- enoxaparin sodium
- Enoxaparin sodium
- Enoxaparin sodium (preservative free)
- enoxaparin sodium preservative free
- inhixa
- Inhixa
- lovenox
- Lovenox
- Lovenox (preservative free)
- lovenox preservative free
- thorinane
- Thorinane
- (Arm Closed) Enoxaparin
- 40mg Enoxaparin
- 60mg Enoxaparin
- arm closed enoxaparin
- Clexane
- Clexane (enoxaparin)
- clexane (LMWH)
- enoxaparin
- Enoxaparin
- Enoxaparin (High-dose Group)
- Enoxaparin (Single-dose PCI Group)
- Enoxaparin (Staged-dose PCI Group)
- Enoxaparin (Standard-dose Group)
- enoxaparin (XRP4563)
- Enoxaparin 30 mg BID
- Enoxaparin 40 mg
- Enoxaparin 4000 IU
- enoxaparin sodium
- Enoxaparin sodium
- Enoxaparin Sodium
- Enoxaparin Sodium (Lovenox®)
- Enoxaparin Sodium (Venus Remedies Limited)
- Enoxaparin sodium (XRP4563)
- ENOXAPARIN SODIUM [EP MONOGRAPH]
- ENOXAPARIN SODIUM [HSDB]
And 56 more, listed on the interactive page.
- ATC classification codes
- B01AB05
Sources for recorded values
- CAS registry numbers
- 679809-58-6
- ChEMBL ID
- CHEMBL1201476
- PubChem compound IDs
- 772
- FDA ingredient codes (UNII)
- 8NZ41MIK1O
- 67108
- 221095
- Applicant
- SANOFI AVENTIS US
- Approval date
- 29 Mar 1993
- Application number
- NDA020164
- Status
- Authorised
- Status date
- 15 Sept 2016
- Authorisation date
- 15 Sept 2016
- Approved indications
- Inhixa is indicated for adults for: Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery. Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL). Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism. Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA). Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL). Blood clot prevention in the extracorporeal circulation during haemodialysis.
- Product number
- EMEA/H/C/004264
- Authorisation holder
- Techdow Pharma Netherlands B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- Yes
- Generic medicines
- 0
- Biosimilar medicines
- 1
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Venous Thromboembolism
European medicines record
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- enoxaparin
- Type
- Synthetic organic
- Drug name stem
- -parin
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Activation
- Action type
- ACTIVATION
- Target
- serpin family C member 1
- Gene symbol
- SERPINC1
- Protein identifier
- P01008
- Primary target
- Yes
- Mechanism
- Antithrombin-III activator
- Action type
- ACTIVATOR
- Target
- Antithrombin-III
- Protein identifier
- P01008
Open Targets mechanisms
- Mechanism
- Antithrombin-III activator
- Action type
- ACTIVATOR
- Target
- Antithrombin-III
- Condition
- Atrial Fibrillation
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000275
- Subject identifier
- D001281
- Condition
- Fetal Growth Retardation
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000495
- Subject identifier
- D005317
- Condition
- Infections
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Myocardial Infarction
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000612
- Subject identifier
- D009203
- Condition
- Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Stroke
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000712
- Subject identifier
- D020521
- Condition
- Obesity
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Liver Cirrhosis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001422
- Subject identifier
- D008103
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002916
- Subject identifier
- D004938
- Condition
- Pregnancy
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002950
- Subject identifier
- D011247
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Pulmonary Embolism
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003827
- Subject identifier
- D011655
- Condition
- Venous Thrombosis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003907
- Subject identifier
- D020246
- Condition
- Nephrotic Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004255
- Subject identifier
- D009404
- Condition
- Venous Thromboembolism
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004286
- Subject identifier
- D054556
- Condition
- Acute Coronary Syndrome
- Highest recorded phase
- 1
- Condition identifier
- EFO:0005672
- Subject identifier
- D054058
- Condition
- Staphylococcal Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005681
- Subject identifier
- D013203
- Condition
- Myocardial Infarction
- Highest recorded phase
- 4
- Condition identifier
- EFO:0008583
- Subject identifier
- D009203
- Condition
- ST Elevation Myocardial Infarction
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008585
- Subject identifier
- D000072657
- Condition
- Blood Coagulation Disorders
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009314
- Subject identifier
- D001778
- Condition
- Abortion, Habitual
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000954
- Subject identifier
- D000026
- Condition
- Angina, Unstable
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000985
- Subject identifier
- D000789
And 9 more, listed on the interactive page.
- Condition identifier
- EFO_0000612
- Condition identifier
- EFO_0002916
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002950
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003827
- Condition identifier
- EFO_0003907
- Condition identifier
- EFO_0003907
- Highest recorded phase
- 4
- Condition identifier
- EFO_0003913
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003964
- Condition identifier
- EFO_0004286
- Condition identifier
- EFO_0004352
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005672
- Highest recorded phase
- 1
- Condition identifier
- EFO_0009806
- Highest recorded phase
- 3
- Condition identifier
- EFO_0020925
- Highest recorded phase
- 3
- Condition identifier
- HP_0000789
- Highest recorded phase
- 1
- Condition identifier
- HP_0001297
- Condition identifier
- HP_0004419
- Condition identifier
- HP_0004419
- Highest recorded phase
- 4
- Condition identifier
- HP_0004936
- Condition identifier
- MONDO_0000491
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0000831
- Condition identifier
- MONDO_0000831
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0001106
- Condition identifier
- MONDO_0001531
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002492
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 2
And 21 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- vascular toxicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- vascular toxicity
- Country
- United States
- Event
- abdominal wall haematoma
- Reports
- 239
- Reporting signal score
- 769.905
- Event
- activated partial thromboplastin time prolonged
- Reports
- 210
- Reporting signal score
- 430.598
- Event
- acute generalised exanthematous pustulosis
- Reports
- 161
- Reporting signal score
- 279.766
- Event
- anaemia
- Reports
- 932
- Reporting signal score
- 411.913
- Event
- cerebral haemorrhage
- Reports
- 242
- Reporting signal score
- 270.967
- Event
- cholestasis
- Reports
- 272
- Reporting signal score
- 295.548
- Event
- deep vein thrombosis
- Reports
- 547
- Reporting signal score
- 428.995
- Event
- diarrhoea
- Reports
- 185
- Reporting signal score
- 300.726
- Event
- drug reaction with eosinophilia and systemic symptoms
- Reports
- 330
- Reporting signal score
- 334.698
- Event
- eosinophilia
- Reports
- 207
- Reporting signal score
- 288.726
- Event
- fatigue
- Reports
- 185
- Reporting signal score
- 340.215
- Event
- foetal growth restriction
- Reports
- 168
- Reporting signal score
- 299.151
- Event
- gastrointestinal haemorrhage
- Reports
- 486
- Reporting signal score
- 308.061
- Event
- haematocrit decreased
- Reports
- 245
- Reporting signal score
- 270.676
- Event
- haematoma
- Reports
- 873
- Reporting signal score
- 1,802.55
- Event
- haematuria
- Reports
- 331
- Reporting signal score
- 299.907
- Event
- haemoglobin decreased
- Reports
- 739
- Reporting signal score
- 530.972
- Event
- haemorrhage
- Reports
- 831
- Reporting signal score
- 954.608
- Event
- heparin-induced thrombocytopenia
- Reports
- 1,425
- Reporting signal score
- 5,770.78
- Event
- hepatocellular injury
- Reports
- 335
- Reporting signal score
- 404.937
- Event
- injury associated with device
- Reports
- 293
- Reporting signal score
- 625.598
- Event
- international normalised ratio increased
- Reports
- 322
- Reporting signal score
- 277.675
- Event
- intra-abdominal haematoma
- Reports
- 73
- Reporting signal score
- 222.177
- Event
- low birth weight baby
- Reports
- 244
- Reporting signal score
- 459.619
- Event
- muscle haemorrhage
- Reports
- 198
- Reporting signal score
- 481.8
And 9 more, listed on the interactive page.
- NCT00043784
- NCT00077792
- NCT00121446
- NCT00623623
- NCT02181985
- NCT02181998
- NCT03568838
- NCT00077753
- NCT00329628
- NCT00331838
- NCT00332020
- NCT00361894
- NCT00362232
- NCT00396786
- NCT00398905
- NCT00493896
- NCT00571649
- NCT00641732
- NCT00657150
- NCT00679588
- NCT00697099
- NCT00714597
- NCT00718224
- NCT00721760
- NCT00902928
And 74 more, listed on the interactive page.
- Dose
- 40 mg
- Route
- Subcutaneous
- How often
- Once daily
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 0075-0620
- 0075-0621
- 0075-0622
- 0075-0623
- 0075-0624
- 0075-0626
- 0075-2912
- 0075-2915
- 0075-8013
- 0075-8014
- 0075-8016
- 0075-8018
- 0075-8020
- 0075-8022
- 0075-8025
- 0075-8030
- 0548-5601
- 0548-5602
- 0548-5603
- 0548-5604
- 0548-5605
- 0548-5606
- 0548-5607
- 0548-5608
- 0781-3238
And 118 more, listed on the interactive page.
- Recorded assays
- 94
- Active assays
- 1
Active assay types
- Other
Related records
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- A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis
- A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries
- A Clinical Study of SHR-2004 Injection in Preventing Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty
- A Clinical Trial on Diabetic Foot Using Peripheral Blood Derived Stem Cells for Treating Critical Limb Ischemia
- A Cohort Study on ctDNA MRD in Neoadjuvant Therapy for Pancreatic Cancer
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- A Comparative Study of Prophylactic Anticoagulation in Meningioma Surgery
- A Comparison of Dilute Versus Concentrated Heparin for CRRT Anticoagulation
- A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis
- A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
- A Different Approach to Preventing Thrombosis
- A Dose Escalation and Dose Expansion Clinical Study of STI-7349 in Subjects With Advanced Solid Tumors
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Approved for (5)
- Acute myocardial infarction
- Myocardial infarction
- Pulmonary embolism
- Thrombotic disease
- Venous thromboembolism
In development for (22)
- Acute coronary syndrome Phase 1
- Atrial fibrillation Phase 3
- Blood coagulation disease Phase 2
- Cancer Phase 3
- Carcinoma of esophagus Phase 2
- Cirrhosis of liver Phase 2
- COVID-19 Phase 3
- Exocrine pancreatic carcinoma Phase 2
- Fetal growth restriction Phase 3
- Habitual spontaneous abortion Phase 3
- Intermediate coronary syndrome Phase 3
- Lymphoma Phase 1
- Myocardial ischemia Phase 3
- Neoplasm Phase 3
- Nephrotic syndrome Phase 2
- Non-small cell lung carcinoma Phase 3
- Obesity disorder Phase 3
- Ovarian cancer Phase 2
- Small cell lung carcinoma Phase 2
- ST-elevation myocardial infarction Phase 3
Other linked conditions (1)
- Hip fracture
Targets (1)
- SERPINC1 Antithrombin-III activator