> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/iron-isomaltoside-1000-8f78d416-6b53-49f1-8d80-ded37eeb0ccf
> Record changed: 2026-10-13

# Iron isomaltoside 1000

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298046)

Drug type

Unknown

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298046)

## Names and chemistry

**Drug type**

Unknown

**Drug name**

Iron isomaltoside 1000

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298046)

### Other names (27)

- 1000 mg iron isomaltoside 1000
- 500 mg iron isomaltoside 1000
- diafer
- Diafer
- IRON (AS IRON(III) ISOMALTOSIDE 1000)
- iron as iron iii isomaltoside 1000
- iron isomaltoside (Monofer) intravenous infusion
- iron isomaltoside 1000
- Iron isomaltoside 1000
- Iron Isomaltoside 1000
- iron isomaltoside 1000 (Monofer®)
- Iron isomaltoside 1000 (Monofer®)
- Iron isomaltoside 1000 \[WHO-DD\]
- iron isomaltoside 1000 who dd
- iron isomaltoside(Monofer®)
- isofer
- Isofer
- jilazo
- Jilazo
- monofer
- Monofer
- MonoFer
- Monofer (experimental)
- Monofer (iron isomaltoside 1000)
- Monofer (isomaltoside)

And 2 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 1370654-58-2

**ChEMBL ID**

CHEMBL4298046

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298046)

**FDA ingredient codes (UNII)**

- 3M6325NY1R

## Regulatory information

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

## Pharmacology

### Investigated indications (7)

- **Condition**  
Inflammatory Bowel Diseases

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003767

**Subject identifier**  
D015212
- **Condition**  
Renal Insufficiency, Chronic

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003884

**Subject identifier**  
D051436
- **Condition**  
Restless Legs Syndrome

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0004270

**Subject identifier**  
D012148
- **Condition**  
Anemia

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0004272

**Subject identifier**  
D000740
- **Condition**  
Postpartum Hemorrhage

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0009579

**Subject identifier**  
D006473
- **Condition**  
Anemia, Iron-Deficiency

**Highest recorded phase**  
3

**Condition identifier**  
HP:0001891

**Subject identifier**  
D018798
- **Condition**  
Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369

### Open Targets indications (52)

- **Condition identifier**  
EFO\_0000266

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001070
- **Condition identifier**  
EFO\_0002950

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003767

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003884

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003917

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003965

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0004272

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0009518
- **Condition identifier**  
EFO\_0009579

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0009909
- **Condition identifier**  
EFO\_0020988

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1001905
- **Condition identifier**  
HP\_0001513
- **Condition identifier**  
HP\_0001518

**Highest recorded phase**  
1
- **Condition identifier**  
HP\_0001891
- **Condition identifier**  
HP\_0001891

**Highest recorded phase**  
4
- **Condition identifier**  
HP\_0002239

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0012378

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0012758
- **Condition identifier**  
MONDO\_0000313

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0000565
- **Condition identifier**  
MONDO\_0001056

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0001676
- **Condition identifier**  
MONDO\_0002280

**Highest recorded phase**  
3

And 27 more, listed on the interactive page.

### Reported adverse events (56)

- **Event**  
abdominal pain

**Reports**  
59

**Reporting signal score**

25.5861
- **Event**  
acute cardiac event

**Reports**  
1

**Reporting signal score**

6.42987
- **Event**  
allergy to metals

**Reports**  
8

**Reporting signal score**

35.1431
- **Event**  
anaphylactic reaction

**Reports**  
41

**Reporting signal score**

42.4417
- **Event**  
autism spectrum disorder

**Reports**  
8

**Reporting signal score**

23.2316
- **Event**  
back pain

**Reports**  
71

**Reporting signal score**

55.2236
- **Event**  
blood iron decreased

**Reports**  
14

**Reporting signal score**

28.8894
- **Event**  
bradycardia

**Reports**  
15

**Reporting signal score**

33.443
- **Event**  
bradycardia foetal

**Reports**  
3

**Reporting signal score**

14.2121
- **Event**  
caesarean section

**Reports**  
3

**Reporting signal score**

6.64192
- **Event**  
cardiac arrest

**Reports**  
6

**Reporting signal score**

12.7639
- **Event**  
chest crushing

**Reports**  
4

**Reporting signal score**

23.5679
- **Event**  
chest discomfort

**Reports**  
58

**Reporting signal score**

67.0768
- **Event**  
chest pain

**Reports**  
45

**Reporting signal score**

20.4784
- **Event**  
crohn's disease

**Reports**  
24

**Reporting signal score**

20.3672
- **Event**  
cyanosis

**Reports**  
5

**Reporting signal score**

13.3438
- **Event**  
device interaction

**Reports**  
8

**Reporting signal score**

36.2152
- **Event**  
discomfort

**Reports**  
4

**Reporting signal score**

7.29231
- **Event**  
drug hypersensitivity

**Reports**  
91

**Reporting signal score**

58.8923
- **Event**  
drug intolerance

**Reports**  
36

**Reporting signal score**

21.6428
- **Event**  
dyspnoea

**Reports**  
150

**Reporting signal score**

87.233
- **Event**  
faeces discoloured

**Reports**  
20

**Reporting signal score**

31.9482
- **Event**  
fishbane reaction

**Reports**  
22

**Reporting signal score**

150.59
- **Event**  
flushing

**Reports**  
64

**Reporting signal score**

88.7504
- **Event**  
food allergy

**Reports**  
9

**Reporting signal score**

20.1103

And 31 more, listed on the interactive page.

### Trial references (17)

- NCT01017614  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01017614)
- NCT01213680  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01213680)
- NCT01599702  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01599702)
- NCT01213979  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01213979)
- NCT01213992  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01213992)
- NCT01222884  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01222884)
- NCT02940860  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02940860)
- NCT01280240  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01280240)
- NCT01895205  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01895205)
- NCT01895218  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01895218)
- NCT02172001  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02172001)
- NCT02940886  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02940886)
- NCT02962648  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02962648)
- NCT03237065  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03237065)
- NCT03238911  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03238911)
- NCT05251493  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05251493)
- NCT02484768  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02484768)

## Chemical properties

**Prodrug**

No

**Inorganic**

No

**Natural product**

No

## Related records

### Trials (362)

- "Predictive Models of the Morphological Evolution of the Human Body to Improve Adherence and Motivation in Dietetic-nutritional Treatments of Overweight and Obesity" \[Modelos Predictivos de Evolución Corporal Para Mejorar la Adherencia en Tratamientos de Sobrepeso y Obesidad\]
- 2nd Line Treatment With Pemetrexed and Sorafenib for Recurrent or Metastatic Triple Negative Breast Cancer
- 3VM for Treatment of Chronic Osteoarthritis Knee Pain
- A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)
- A Clinical Study to Evaluate the Efficacy of a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation
- A Clinical Trial Evaluating JYP0035 Capsule Monotherapy in Patients With Advanced Solid Tumors
- [A Clinical Trial Evaluating the Monkeypox Recombinant Protein Vaccine](https://trialight.com/data/trial/a-clinical-trial-evaluating-the-monkeypox-recombinant-1522c4bd-c77b-45e3-8a10-45f9209b34d6.md)
- A Clinical Trial for Inactivated Japanese Encephalitis Vaccine in Healthy Chinese Infants
- A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab in Acute Bronchitis Patients
- A Clinical Trial to Evaluate the Safety and Efficacy of "AG1904" in Acute Bronchitis
- A Clinical Trial to Test the Effect of a Marketed Mouth Rinse on Stain Removal
- A Combination Efficacy Study in Africa of Two DNA-MVA-Env Protein or DNA-Env Protein HIV-1 Vaccine Regimens With PrEP
- A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer
- A Comparison of Two Albumin Administration Schedules for Spontaneous Bacterial Peritonitis
- A First-in-Human Study With XAB05 in Healthy Subjects
- A Multi-center, Two-arm, Phase 2 Clinical Study on the Perioperative Treatment of HER2-positive Resectable Esophagogastric Junctional Adenocarcinoma With Nabulimab Combined With FLOT and Trastuzumab VS FLOT Combined With Trastuzumab
- A Multiple Ascending Dose Study of LW402 in Healthy Volunteers
- A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency
- A Pharmacokinetic Study of an Experimental Paracetamol Formulation
- A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma

### In development for (6)

- Anemia Phase 1
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 1
- [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Phase 3
- [Inflammatory bowel disease](https://trialight.com/data/condition/inflammatory-bowel-disease-619080ac-2d43-5ad3-b078-9699e1241655.md) Phase 3
- Iron deficiency anemia Phase 3
- Restless legs syndrome Phase 2

---

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