> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/fludarabine-e03241fb-ac4f-4851-ae4f-6e8dad4f1d28
> Record changed: 2026-11-04

# Fludarabine

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1568)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1568)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1568)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1568)

**Drug name**

Fludarabine

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1568)

**Molecular weight**

285.24

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1568)

**Structure (SMILES)**

Nc1nc(F)nc2c1ncn2\[C@@H\]1O\[C@H\](CO)\[C@@H\](O)\[C@@H\]1O

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1568)

### Other names (36)

- 2 f araa
- 2 fluoro 9 beta d arabinofuranosyladenine
- 2 fluoro ara a
- 2 fluorovidarabine
- 2-f-araa
- 2-fluoro ara-a
- 2-FLUORO-9-.BETA.-D-ARABINOFURANOSYLADENINE
- 2-fluorovidarabine
- 9 beta d arabinofuranosyl 2 fluoro 9h purin 6 amine
- 9 beta d arabinofuranosyl 2 fluoroadenine
- 9-.BETA.-D-ARABINOFURANOSYL-2-FLUORO-9H-PURIN-6-AMINE
- 9-.BETA.-D-ARABINOFURANOSYL-2-FLUOROADENINE
- fludarabina
- Fludarabina
- fludarabine
- Fludarabine
- FLUDARABINE \[HSDB\]
- fludarabine \[INN\]
- FLUDARABINE \[MI\]
- FLUDARABINE \[VANDF\]
- Fludarabine \[WHO-DD\]
- fludarabine hsdb
- fludarabine inn
- fludarabine mi
- fludarabine phosphate impurity 2 fluoro ara adenine usp impurity

And 11 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- L01BB05

Sources for recorded values

Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=24698)

**CAS registry numbers**

- 21679-14-1

**ChEMBL ID**

CHEMBL1568

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1568)

**InChIKey**

HBUBKKRHXORPQB-FJFJXFQQSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1568)

**PubChem compound IDs**

- 657237

**RxNorm IDs (RxCUI)**

- 24698

**FDA ingredient codes (UNII)**

- P2K93U8740

## Regulatory information

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

## Pharmacology

### Drug classification

**Pharmacology name**

fludarabine

**Type**

Synthetic organic

**Drug name stem**

\-arabine

**Approval recorded by Guide to Pharmacology**

Yes

### Mechanisms of action (2)

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
ribonucleotide reductase catalytic subunit M1

**Gene symbol**  
RRM1

**Protein identifier**  
P23921

**Median affinity**  
6

**Affinity units**  
pIC50

**Primary target**  
Yes
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
ribonucleotide reductase regulatory subunit M2

**Gene symbol**  
RRM2

**Protein identifier**  
P31350

**Median affinity**  
6

**Affinity units**  
pIC50

**Primary target**  
Yes

### Investigated indications (118)

- **Condition**  
Leukemia, Biphenotypic, Acute

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000094

**Subject identifier**  
D015456
- **Condition**  
Leukemia, Lymphocytic, Chronic, B-Cell

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000095

**Subject identifier**  
D015451
- **Condition**  
Lymphoma, Follicular

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000096

**Subject identifier**  
D008224
- **Condition**  
Sarcoma, Ewing

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000174

**Subject identifier**  
D012512
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000181

**Subject identifier**  
D002294
- **Condition**  
Carcinoma, Hepatocellular

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000182

**Subject identifier**  
D006528
- **Condition**  
Hodgkin Disease

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000183

**Subject identifier**  
D006689
- **Condition**  
Lymphoma, B-Cell, Marginal Zone

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000191

**Subject identifier**  
D018442
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000196

**Subject identifier**  
D011471
- **Condition**  
Myelodysplastic Syndromes

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000198

**Subject identifier**  
D009190
- **Condition**  
Leukemia, Biphenotypic, Acute

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000209

**Subject identifier**  
D015456
- **Condition**  
Lymphoma, T-Cell, Peripheral

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000211

**Subject identifier**  
D016411
- **Condition**  
Precursor Cell Lymphoblastic Leukemia-Lymphoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000220

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

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000222

**Subject identifier**  
D015470
- **Condition**  
Burkitt Lymphoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000309

**Subject identifier**  
D002051
- **Condition**  
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000339

**Subject identifier**  
D015464
- **Condition**  
Carcinoma, Renal Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000349

**Subject identifier**  
D002292
- **Condition**  
Crohn Disease

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000384

**Subject identifier**  
D003424
- **Condition**  
Melanoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000389

**Subject identifier**  
D008545
- **Condition**  
Lymphoma, Large B-Cell, Diffuse

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000403

**Subject identifier**  
D016403
- **Condition**  
Neoplasms, Germ Cell and Embryonal

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000514

**Subject identifier**  
D009373
- **Condition**  
Glioblastoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000519

**Subject identifier**  
D005909
- **Condition**  
Immune System Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000540

**Subject identifier**  
D007154
- **Condition**  
Leukemia

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000565

**Subject identifier**  
D007938
- **Condition**  
Adenocarcinoma of Lung

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000571

**Subject identifier**  
D000077192

And 93 more, listed on the interactive page.

### Open Targets indications (292)

- **Condition identifier**  
EFO\_0000095

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000096

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

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000220
- **Condition identifier**  
EFO\_0000222

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000339

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000389

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000403

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000519

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0000544

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

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000574
- **Condition identifier**  
EFO\_0000616

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000676

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000756

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000768

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0001378

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0002617

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003778

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003863

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

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0004272

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0004352

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0004599

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0005952

**Highest recorded phase**  
3

And 267 more, listed on the interactive page.

### Reported adverse events (59)

- **Event**  
acute graft versus host disease

**Reports**  
435

**Reporting signal score**  
1,606.97
- **Event**  
acute graft versus host disease in intestine

**Reports**  
114

**Reporting signal score**

425.42
- **Event**  
acute graft versus host disease in skin

**Reports**  
298

**Reporting signal score**  
1,171.09
- **Event**  
acute lymphocytic leukaemia recurrent

**Reports**  
64

**Reporting signal score**

168.792
- **Event**  
acute myeloid leukaemia

**Reports**  
164

**Reporting signal score**

324.044
- **Event**  
acute myeloid leukaemia recurrent

**Reports**  
53

**Reporting signal score**

170.905
- **Event**  
adenovirus infection

**Reports**  
207

**Reporting signal score**

751.051
- **Event**  
autoimmune haemolytic anaemia

**Reports**  
126

**Reporting signal score**

334.285
- **Event**  
bacteraemia

**Reports**  
145

**Reporting signal score**

244.925
- **Event**  
bk virus infection

**Reports**  
135

**Reporting signal score**

372.819
- **Event**  
bone marrow failure

**Reports**  
220

**Reporting signal score**

288.649
- **Event**  
bronchopulmonary aspergillosis

**Reports**  
139

**Reporting signal score**

323.895
- **Event**  
chronic graft versus host disease

**Reports**  
272

**Reporting signal score**

901.545
- **Event**  
chronic graft versus host disease in skin

**Reports**  
48

**Reporting signal score**

143.811
- **Event**  
chronic lymphocytic leukaemia

**Reports**  
78

**Reporting signal score**

169.818
- **Event**  
chronic lymphocytic leukaemia recurrent

**Reports**  
199

**Reporting signal score**

886.222
- **Event**  
cystitis haemorrhagic

**Reports**  
195

**Reporting signal score**

585.075
- **Event**  
cytokine release syndrome

**Reports**  
494

**Reporting signal score**  
1,537.74
- **Event**  
cytomegalovirus chorioretinitis

**Reports**  
66

**Reporting signal score**

170.463
- **Event**  
cytomegalovirus infection

**Reports**  
629

**Reporting signal score**  
1,744.25
- **Event**  
cytomegalovirus infection reactivation

**Reports**  
211

**Reporting signal score**

756.221
- **Event**  
cytomegalovirus viraemia

**Reports**  
192

**Reporting signal score**

568.042
- **Event**  
cytopenia

**Reports**  
119

**Reporting signal score**

192.716
- **Event**  
dizziness

**Reports**  
64

**Reporting signal score**

150.013
- **Event**  
engraftment syndrome

**Reports**  
70

**Reporting signal score**

275.037

And 34 more, listed on the interactive page.

### Trial references (545)

- NCT00001422  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001422)
- NCT00003552  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003552)
- NCT00338377  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00338377)
- NCT00509288  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00509288)
- NCT00923195  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00923195)
- NCT00924001  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00924001)
- NCT01585415  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01585415)
- NCT01883323  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01883323)
- NCT01946373  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01946373)
- NCT02111863  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02111863)
- NCT02621021  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02621021)
- NCT03166397  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03166397)
- NCT06190249  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06190249)
- NCT00004485  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004485)
- NCT00040417  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00040417)
- NCT00408447  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00408447)
- NCT00489281  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00489281)
- NCT00968162  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00968162)
- NCT01850108  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01850108)
- NCT01877837  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01877837)
- NCT02435901  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02435901)
- NCT02678143  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02678143)
- NCT02766465  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02766465)
- NCT03121001  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03121001)
- NCT03263559  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03263559)

And 520 more, listed on the interactive page.

## Chemical properties

**Hydrogen bond acceptors**

9

**Hydrogen bond donors**

4

**Polar surface area**

139.54

**Calculated partition coefficient (ALogP)**

\-1.84

**Calculated partition coefficient (XLogP)**

\-0.6

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

2

**Heavy atoms**

20

**Molecular formula**

C10H12FN5O4

**Monoisotopic mass**

285.08733204

**Natural product**

No

## Evidence counts

**Recorded assays**

2,609

**Active assays**

306

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## Pharmacologic actions

- Antineoplastic Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000970.html)

## Related records

### Trials (1,227)

- 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
- 3RD GENERATION GD2 SPECIFIC CHIMERIC ANTIGEN RECEPTOR TRANSDUCED AUTOLOGOUS NATURAL KILLER T-CELLS FOR NEUROBLASTOMA
- A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome
- A Clinical Study of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer(FASTIL-Lung02)
- a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients
- A Clinical Trial of the Safety and Anti-Tumor Activity of AB-201 in Subjects With Advanced HER2+ Solid Tumors
- 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 Comparison of Reduced Dose Total Body Irradiation (TBI) and Cyclophosphamide With Fludarabine and Melphalan Reduced Intensity Conditioning in Adults With Acute Lymphoblastic Leukaemia (ALL) in Complete Remission. (ALL-RIC)
- A Controlled Trial of Intermittent Fludarabine for Psoriatic Arthritis
- A Dose Escalation Study of Intensity Modulated Total Marrow Irradiation (IMRT-TMI) Followed by Fludarabine as a Myeloablative Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed and Refractory Hematologic Malignancies
- A Dose-escalation Study to Evaluate the Safety and Clinical Activity of PBCAR269A, With or Without Nirogacestat, in Study Participants With Relapsed/Refractory Multiple Myeloma
- A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
- A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant
- A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors
- A Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Hodgkin's Lymphoma
- A Multicenter Clinical Study on the Safety and Efficacy of CAR-T in the Treatment of Relapsed / Refractory Non Hodgkin's Lymphoma
- A Myeloablative Conditioning Regimen and Total Body Irradiation Followed by the Transplantation for Patients With Hematological Malignancy
- A Phase 1 Study of ADI-001 in B Cell Malignancies
- A Phase 1 Study of ADI-001 in Rheumatoid Arthritis
- A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL

### In development for (257)

- [Acquired idiopathic inflammatory myopathy](https://trialight.com/data/condition/acquired-idiopathic-inflammatory-myopathy-18d0eb22-6fbd-59d0-889d-3ac4266a57f2.md) Phase 1
- Acquired polycythemia vera Phase 2
- Acute erythroid leukemia Phase 2
- Acute leukemia Phase 2
- Acute leukemia of ambiguous lineage Phase 1
- [Acute lymphoblastic leukemia](https://trialight.com/data/condition/acute-lymphoblastic-leukemia-a7f89294-3477-5920-8fe1-8aa51fcd1d63.md) Phase 3
- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 3
- Adult T-cell leukemia/lymphoma Phase 1
- [AL amyloidosis](https://trialight.com/data/condition/al-amyloidosis-42ae488b-dbd7-50a6-8ec6-a47098470cd8.md) Phase 1
- Alveolar rhabdomyosarcoma Phase 2
- Alveolar soft part sarcoma Phase 1
- Anal carcinoma Phase 2
- Anal squamous cell carcinoma Phase 2
- Anaplastic large cell lymphoma Phase 1
- Anemia Phase 1
- [Angioimmunoblastic T-cell lymphoma](https://trialight.com/data/condition/angioimmunoblastic-t-cell-lymphoma-5b697108-b9cf-53e9-afde-71a36bf55d6b.md) Phase 2
- [Anti-neutrophil cytoplasmic antibody-associated vasculitis](https://trialight.com/data/condition/anti-neutrophil-cytoplasmic-antibody-associated-vasculitis-a59f9899-4e99-54af-98e3-b03dbdb0192e.md) Phase 1
- Antisynthetase syndrome Phase 2
- Aplastic anemia Phase 3
- [Autoimmune disease](https://trialight.com/data/condition/autoimmune-disease-8a8fd8aa-2d04-5f24-b839-ba96a70c11e9.md) Phase 1

### Other linked conditions (1)

- High grade B-cell lymphoma

### Targets (2)

- [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md)
- [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md)

---

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- Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too.
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