> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/idarubicin-f78dfc0f-d086-44ed-9f72-28281852e0fa
> Record changed: 2026-11-04

# Idarubicin

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

First approval year

1990

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

## Development status

**First approval year**

1990

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

**Drug name**

Idarubicin

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

**Molecular weight**

497.5

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

**Structure (SMILES)**

CC(=O)\[C@\]1(O)Cc2c(O)c3c(c(O)c2\[C@@H\](O\[C@H\]2C\[C@H\](N)\[C@H\](O)\[C@H\](C)O2)C1)C(=O)c1ccccc1C3=O

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

### Other names (21)

- (1S,3S)-3-ACETYL-1,2,3,4,6,11-HEXAHYDRO-3,5,12-TRIHYDROXY-6,11-DIOXO-1-NAPHTHACENYL 3-AMINO-2,3,6-TRIDEOXY-.ALPHA.-L-LYXO-HEXOPYRANOSIDE
- 1s 3s 3 acetyl 1 2 3 4 6 11 hexahydro 3 5 12 trihydroxy 6 11 dioxo 1 naphthacenyl 3 amino 2 3 6 trideoxy alpha l lyxo hexopyranoside
- 5 12 naphthacenedione 9 acetyl 7 3 amino 2 3 6 trideoxy alpha l lyxo hexopyranosyl oxy 7 8 9 10 tetrahydro 6 9 11 trihydroxy 7s 9s
- 5,12-NAPHTHACENEDIONE, 9-ACETYL-7-((3-AMINO-2,3,6-TRIDEOXY-.ALPHA.-L-LYXO-HEXOPYRANOSYL)OXY)-7,8,9,10-TETRAHYDRO-6,9,11-TRIHYDROXY-, (7S,9S)-
- idarubicin
- Idarubicin
- idarubicin \[INN\]
- IDARUBICIN \[MI\]
- IDARUBICIN \[VANDF\]
- Idarubicin \[WHO-DD\]
- idarubicin inn
- idarubicin mi
- idarubicin vandf
- idarubicin who dd
- idarubicina
- Idarubicina
- idarubicine
- Idarubicine
- IDARUBICINE
- zavedos
- ZAVEDOS

## Identifiers

**ATC classification codes**

- L01DB06

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

**CAS registry numbers**

- 58957-92-9

**ChEMBL ID**

CHEMBL1117

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

**InChIKey**

XDXDZDZNSLXDNA-TZNDIEGXSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1117)

**PubChem compound IDs**

- 42890

**RxNorm IDs (RxCUI)**

- 5650

**FDA ingredient codes (UNII)**

- ZRP63D75JW

## Regulatory information

### United States

**Applicant**

PFIZER

**Approval date**

27 Sept 1990

**Application number**

NDA050661

### Other regulatory facts

**Patents**

0

**Designations**

1

**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

**Boxed warning**

Yes

## Approval status

**United States (FDA)**

Approved

## Pharmacology

### Drug classification

**Pharmacology name**

idarubicin

**Type**

Natural product

**Drug name stem**

\-rubicin

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Parenteral

### Open Targets mechanisms

- **Mechanism**  
DNA topoisomerase II alpha inhibitor

**Action type**  
Inhibitor

**Target**  
DNA topoisomerase 2-alpha

### DrugCentral mechanisms

- **Action type**  
Inhibitor

**Gene symbol**  
TOP2A

**Protein identifier**  
P11388

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (28)

- **Condition**  
Carcinoma, Hepatocellular

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000182

**Subject identifier**  
D006528
- **Condition**  
Myelodysplastic Syndromes

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000198

**Subject identifier**  
D009190
- **Condition**  
Neoplasms, Plasma Cell

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000200

**Subject identifier**  
D054219
- **Condition**  
Leukemia, Erythroblastic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000218

**Subject identifier**  
D004915
- **Condition**  
Precursor Cell Lymphoblastic Leukemia-Lymphoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000220

**Subject identifier**  
D054198
- **Condition**  
Leukemia, Monocytic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000221

**Subject identifier**  
D007948
- **Condition**  
Leukemia, Myeloid, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000222

**Subject identifier**  
D015470
- **Condition**  
Leukemia, Myelomonocytic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000223

**Subject identifier**  
D015479
- **Condition**  
Leukemia, Promyelocytic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000224

**Subject identifier**  
D015473
- **Condition**  
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000339

**Subject identifier**  
D015464
- **Condition**  
Leukemia

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000565

**Subject identifier**  
D007938
- **Condition**  
Lymphoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000574

**Subject identifier**  
D008223
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Multiple Myeloma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0001378

**Subject identifier**  
D009101
- **Condition**  
Myeloproliferative Disorders

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0002428

**Subject identifier**  
D009196
- **Condition**  
Leukemia, Megakaryoblastic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003025

**Subject identifier**  
D007947
- **Condition**  
Leukemia, Myeloid, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003027

**Subject identifier**  
D015470
- **Condition**  
Anemia, Refractory

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003802

**Subject identifier**  
D000753
- **Condition**  
Anemia, Refractory, with Excess of Blasts

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003811

**Subject identifier**  
D000754
- **Condition**  
Myeloproliferative Disorders

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0004251

**Subject identifier**  
D009196
- **Condition**  
Lymphoma, Non-Hodgkin

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0005952

**Subject identifier**  
D008228
- **Condition**  
Leukemia, Erythroblastic, Acute

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1001257

**Subject identifier**  
D004915
- **Condition**  
Leukemia, Myelomonocytic, Chronic

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1001779

**Subject identifier**  
D015477
- **Condition**  
Sarcoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:1001968

**Subject identifier**  
D012509
- **Condition**  
Precursor Cell Lymphoblastic Leukemia-Lymphoma

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0000873

**Subject identifier**  
D054198

And 3 more, listed on the interactive page.

### Open Targets indications (63)

- **Condition identifier**  
EFO\_0000182

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000198

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000220

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000222

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000224

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000565

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000574

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0001378

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0004251

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1000157

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001968

**Highest recorded phase**  
3
- **Condition identifier**  
HP\_0002863

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0000814

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0000872

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0000873

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0002571

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002691

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0003539

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004643

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004947

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004947

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0004963

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0004967

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005059

**Highest recorded phase**  
2

And 38 more, listed on the interactive page.

### Open Targets warnings (2)

- **Warning**  
Black Box Warning

**Effect**  
cardiotoxicity

**Country**  
United States
- **Warning**  
Black Box Warning

**Effect**  
hematological toxicity

**Country**  
United States

### Reported adverse events (90)

- **Event**  
5'nucleotidase increased

**Reports**  
4

**Reporting signal score**

23.6707
- **Event**  
acute lymphocytic leukaemia recurrent

**Reports**  
18

**Reporting signal score**

61.468
- **Event**  
acute myeloid leukaemia

**Reports**  
43

**Reporting signal score**

114.994
- **Event**  
acute myeloid leukaemia recurrent

**Reports**  
20

**Reporting signal score**

86.0432
- **Event**  
acute promyelocytic leukaemia differentiation syndrome

**Reports**  
24

**Reporting signal score**

125.415
- **Event**  
acute respiratory distress syndrome

**Reports**  
14

**Reporting signal score**

19.8565
- **Event**  
adenomatous polyposis coli

**Reports**  
5

**Reporting signal score**

23.5056
- **Event**  
aeromonas infection

**Reports**  
6

**Reporting signal score**

28.3
- **Event**  
aplasia

**Reports**  
10

**Reporting signal score**

25.8459
- **Event**  
aspergillus infection

**Reports**  
13

**Reporting signal score**

29.1045
- **Event**  
bacteraemia

**Reports**  
25

**Reporting signal score**

49.2995
- **Event**  
blood bilirubin increased

**Reports**  
21

**Reporting signal score**

20.2883
- **Event**  
bone marrow failure

**Reports**  
58

**Reporting signal score**

115.349
- **Event**  
bronchopulmonary aspergillosis

**Reports**  
39

**Reporting signal score**

121.037
- **Event**  
cholecystitis

**Reports**  
13

**Reporting signal score**

19.3979
- **Event**  
cholecystitis acute

**Reports**  
13

**Reporting signal score**

26.5728
- **Event**  
chorioretinal disorder

**Reports**  
5

**Reporting signal score**

19.4619
- **Event**  
chromosomal deletion

**Reports**  
4

**Reporting signal score**

17.0692
- **Event**  
clostridium difficile colitis

**Reports**  
13

**Reporting signal score**

18.7747
- **Event**  
colitis

**Reports**  
22

**Reporting signal score**

20.5154
- **Event**  
cranial nerve infection

**Reports**  
3

**Reporting signal score**

17.3906
- **Event**  
cytomegalovirus infection

**Reports**  
19

**Reporting signal score**

26.3861
- **Event**  
cytomegalovirus infection reactivation

**Reports**  
15

**Reporting signal score**

45.0331
- **Event**  
cytopenia

**Reports**  
16

**Reporting signal score**

26.6699
- **Event**  
dedifferentiated liposarcoma

**Reports**  
7

**Reporting signal score**

44.3438

And 65 more, listed on the interactive page.

### Trial references (154)

- NCT00002517  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002517)
- NCT00002532  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002532)
- NCT00002549  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002549)
- NCT00002609  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002609)
- NCT00002658  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002658)
- NCT00002701  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002701)
- NCT00002719  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002719)
- NCT00002761  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002761)
- NCT00002771  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002771)
- NCT00002800  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002800)
- NCT00002812  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002812)
- NCT00002816  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002816)
- NCT00002868  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002868)
- NCT00002926  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002926)
- NCT00002945  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002945)
- NCT00002989  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002989)
- NCT00003178  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003178)
- NCT00003268  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003268)
- NCT00003405  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003405)
- NCT00003602  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003602)
- NCT00003729  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003729)
- NCT00003758  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003758)
- NCT00003783  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003783)
- NCT00004905  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004905)
- NCT00005823  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005823)

And 129 more, listed on the interactive page.

## Dosing

**Dose**

12 mg/m2

**Route**

Intravenous

**How often**

Days 1, 2, and 3 of induction

### Conditions of use

- Administer over 10 to 15 minutes

## Chemical properties

**Hydrogen bond acceptors**

10

**Hydrogen bond donors**

5

**Polar surface area**

176.61

**Calculated partition coefficient (ALogP)**

1.02

**Calculated partition coefficient (XLogP)**

1.9

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

3

**Heavy atoms**

36

**Molecular formula**

C26H27NO9

**Monoisotopic mass**

497.16858144

**Natural product**

Yes

## Evidence counts

**Recorded assays**

1,792

**Active assays**

289

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## Pharmacologic actions

- Antibiotics, Antineoplastic  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000903.html)
- Topoisomerase II Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D059005.html)

## Biological measurements

### Observed measurements

#### Oral bioavailability

**Median**

28

**Mean**

28

**Minimum**

28

**Maximum**

28

**Unit**

%

**Assays**

1

**Standard deviation**

0

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- F

## Related records

### Trials (211)

- A Clinical Trial to Assess the Efficacy and Safety of the Combination of a Drug Call Quizartinib With Chemotherapy (FLAG-IDA) in Patients With Acute Myeloid Leukemia That Has Not Responded to the First Treatment or That Has Returned After the First Treatment
- A Phase II Study of Selinexor Plus Cytarabine and Idarubicin in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
- A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
- A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations
- A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
- A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.
- A Study of Elacytarabine (CP-4055) Plus Idarubicin as Second Course Remission-Induction Therapy in Patients With Acute Myeloid Leukaemia
- A Study of Indoximod in Combination With (7+3) Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
- A Study of LY2181308 Sodium in Patients With Relapsed or Refractory Acute Myeloid Leukemia
- A Study of RO5503781 as a Single Agent or in Combination With Cytarabine in Participants With Acute Myelogenous Leukemia
- A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia
- A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia
- Adoptive Transfer of Haplo-identical DLI for AML and MDS
- Aezea® (Cenersen) and Chemotherapy for AML Subjects ≥ 55 Years of Age With No Response to Frontline Induction Course
- AIDA2000 - Risk-Adapted Therapy for Patients With Acute Promyelocytic Leukemia
- Alisertib for Acute Myeloid Leukemia
- All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
- All-trans Retinoic Acid, and Arsenic +/- Idarubicin
- Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)
- Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

### Approved for (2)

- Acute myeloid leukemia by FAB classification
- [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md)

### In development for (53)

- Acute erythroid leukemia Phase 3
- Acute leukemia Phase 2
- Acute leukemia of ambiguous lineage Phase 2
- [Acute lymphoblastic leukemia](https://trialight.com/data/condition/acute-lymphoblastic-leukemia-a7f89294-3477-5920-8fe1-8aa51fcd1d63.md) Phase 3
- Acute megakaryoblastic leukemia Phase 3
- Acute monocytic leukemia Phase 3
- Acute myeloblastic leukemia without maturation Phase 3
- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 3
- Acute myelomonocytic leukemia M4 Phase 3
- Acute promyelocytic leukemia Phase 3
- Alveolar rhabdomyosarcoma Phase 3
- B-cell acute lymphoblastic leukemia Phase 2
- B-cell adult acute lymphocytic leukemia Phase 2
- B-cell childhood acute lymphoblastic leukemia Phase 2
- Bone marrow neoplasm Phase 3
- Burkitt lymphoma Phase 3
- CD4+/CD56+ hematodermic neoplasm Phase 2
- Chronic myeloid leukemia Phase 2
- [Chronic myelomonocytic leukemia](https://trialight.com/data/condition/chronic-myelomonocytic-leukemia-202fe88e-7b5d-5022-b6d2-095cac037e8e.md) Phase 3
- [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) Phase 3

### Other linked conditions (1)

- Anaplastic large cell lymphoma

### Targets (1)

- [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) DNA topoisomerase II alpha inhibitor

---

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