Ferric derisomaltose
Highest phase reached
Approved
Drug type
Oligosaccharide
First approval year
2020
- First approval year
- 2020
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Oligosaccharide
- Drug name
- Ferric derisomaltose
- diafertm
- Diafertm
- monofartm
- Monofartm
- monoferric
- Monoferric
- monoferrictm
- Monoferrictm
- monoferrotm
- Monoferrotm
- monofertm
- Monofertm
- monovertm
- Monovertm
- .ALPHA.-D-GLUCAN, (1-6)-, REDUCED, REACTION PRODUCTS WITH IRON HYDROXIDE (FE(OH)3)
- alpha d glucan 1 6 reduced reaction products with iron hydroxide fe oh 3
- derisomaltosa ferrica
- Derisomaltosa ferrica
- derisomaltose ferrique
- Derisomaltose ferrique
- ferric derisomaltose
- Ferric derisomaltose
- Ferric Derisomaltose
- ferric derisomaltose [INN]
- FERRIC DERISOMALTOSE [JAN]
- FERRIC DERISOMALTOSE [ORANGE BOOK]
- FERRIC DERISOMALTOSE [USAN]
- Ferric derisomaltose [WHO-DD]
- Ferric Derisomaltose Injection
- ferric derisomaltose inn
- ferric derisomaltose jan
- ferric derisomaltose orange book
- ferric derisomaltose usan
- ferric derisomaltose who dd
- Monoferric
- ns32
- NS32
- CAS registry numbers
- 1345510-43-1
- ChEMBL ID
- CHEMBL4298187
- PubChem compound IDs
- 86278348
- RxNorm IDs (RxCUI)
- 2274394
- FDA ingredient codes (UNII)
- AHU547PI9H
- Applicant
- PHARMACOSMOS
- Approval date
- 16 Jan 2020
- Application number
- NDA208171
- Patents
- 5
- Designations
- 0
- Earliest recorded loss of exclusivity
- 22 Jun 2036
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
Administration routes
- Parenteral
- Condition
- Renal Insufficiency, Chronic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003884
- Subject identifier
- D051436
- Condition
- Anemia
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004272
- Subject identifier
- D000740
- Condition
- Anemia, Iron-Deficiency
- Highest recorded phase
- 4
- Condition identifier
- HP:0001891
- Subject identifier
- D018798
- Condition
- Anemia
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0002280
- Subject identifier
- D000740
- Condition identifier
- EFO_0000266
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003965
- Condition identifier
- EFO_0004272
- Highest recorded phase
- 3
- Condition identifier
- EFO_0020975
- Condition identifier
- HP_0001518
- Condition identifier
- HP_0001891
- Condition identifier
- HP_0001891
- Highest recorded phase
- 4
- Condition identifier
- HP_0012758
- Condition identifier
- MONDO_0000313
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002280
- Condition identifier
- MONDO_0002280
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005252
- Condition identifier
- MONDO_0005300
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005575
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0008170
- Highest recorded phase
- 3
- Event
- abdominal pain
- Reports
- 21
- Reporting signal score
- 8.0099
- Event
- agonal respiration
- Reports
- 3
- Reporting signal score
- 20.6099
- Event
- anaphylactic reaction
- Reports
- 27
- Reporting signal score
- 41.0109
- Event
- anaphylactic shock
- Reports
- 7
- Reporting signal score
- 7.77481
- Event
- back pain
- Reports
- 54
- Reporting signal score
- 74.5141
- Event
- blood pressure decreased
- Reports
- 14
- Reporting signal score
- 15.9344
- Event
- bradycardia
- Reports
- 22
- Reporting signal score
- 25.8326
- Event
- bradycardia foetal
- Reports
- 4
- Reporting signal score
- 14.0789
- Event
- cardiac arrest
- Reports
- 12
- Reporting signal score
- 16.6367
- Event
- cardiovascular symptom
- Reports
- 2
- Reporting signal score
- 9.41105
- Event
- chest discomfort
- Reports
- 47
- Reporting signal score
- 87.1614
- Event
- chest pain
- Reports
- 32
- Reporting signal score
- 29.8567
- Event
- cyanosis
- Reports
- 10
- Reporting signal score
- 18.9021
- Event
- diaphragmalgia
- Reports
- 2
- Reporting signal score
- 9.44244
- Event
- diarrhoea
- Reports
- 4
- Reporting signal score
- 8.53535
- Event
- dizziness
- Reports
- 37
- Reporting signal score
- 13.99
- Event
- dyspnoea
- Reports
- 95
- Reporting signal score
- 95.6445
- Event
- erythema
- Reports
- 19
- Reporting signal score
- 11.6702
- Event
- extravasation
- Reports
- 5
- Reporting signal score
- 9.91444
- Event
- eye movement disorder
- Reports
- 4
- Reporting signal score
- 8.26343
- Event
- feeling hot
- Reports
- 13
- Reporting signal score
- 18.326
- Event
- fishbane reaction
- Reports
- 22
- Reporting signal score
- 171.876
- Event
- flushing
- Reports
- 59
- Reporting signal score
- 131.789
- Event
- hyperhidrosis
- Reports
- 24
- Reporting signal score
- 25.4873
- Event
- hypersensitivity
- Reports
- 31
- Reporting signal score
- 30.4618
And 25 more, listed on the interactive page.
- NCT02940860
- NCT02940886
- NCT02962648
- NCT03237065
- NCT03238911
- NCT04913649
- NCT05179226
- NCT05251493
- NCT05768997
- Dose
- 1000mg
- Route
- Intravenous
- How often
- Once
Conditions of use
- Administer over at least 20 minutes
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 73594-9301
- 73594-9305
- 73594-9310
Related records
Trials (32)
- A Clinical Trial Assessing the Efficacy of Intravenous Iron for the Treatment of Anemia Following Cardiac Surgery
- A Study of Ferric Derisomaltose Injection in Chinese Participants With Iron Deficiency Anemia Under Fasting Conditions
- Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia
- An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
- Ferric Derisomaltose (Iron Isomaltoside) Versus Iron Sucrose for Treatment of Iron Deficiency in Pregnancy
- Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery)
- Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
- High Dose IV Iron Plus ESA in Chemotherapy-induced Anemia
- Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)
- Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
- Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
- Intravenous Iron to Improve Symptoms, Quality of Life and Exercise Capacity in HFpEF With Iron Deficiency
- Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
- Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN
- Intravenous Versus Oral Iron for Treating Iron-Deficiency Anemia in Pregnancy
- Iron Deficiency Anemia (IDA) and the Brain
- Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)
- Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
- IRONCARE: Iron Treatment in Older Patients With Hip Fractures
- IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure
Approved for (2)
- Anemia
- Iron deficiency anemia
In development for (1)
- Chronic kidney disease Phase 3