> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/fruquintinib-e15c1522-cabe-4f7b-a918-3ca55e1ef88a
> Record changed: 2026-10-13

# Fruquintinib

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

First approval year

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

## Development status

**First approval year**

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

**Drug name**

Fruquintinib

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

**Molecular weight**

393.4

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

**Structure (SMILES)**

CNC(=O)c1c(C)oc2cc(Oc3ncnc4cc(OC)c(OC)cc34)ccc12

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

### Brand names (2)

- fruzaqla
- Fruzaqla

### Other names (21)

- camrelizumab fruquintinib
- fruquintinib
- Fruquintinib
- FRUQUINTINIB
- Fruquintinib (HMPL-013)
- fruquintinib \[INN\]
- Fruquintinib \[MI\]
- FRUQUINTINIB \[USAN\]
- Fruquintinib \[WHO-DD\]
- Fruquintinib Capsules
- fruquintinib inn
- fruquintinib mi
- fruquintinib usan
- fruquintinib who dd
- hmpl 013
- Hmpl-013
- HMPL-013
- hmpl013
- HMPL013
- Standard of care (Fruquintinib)
- Targeted Therapy Agent (Fruquintinib)

## Identifiers

**CAS registry numbers**

- 1194506-26-7

**ChEMBL ID**

CHEMBL4303214

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

**InChIKey**

BALLNEJQLSTPIO-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

**PubChem compound IDs**

- 44480399

**RxNorm IDs (RxCUI)**

- 2670179

**FDA ingredient codes (UNII)**

- 49DXG3M5ZW

### ATC classification codes (2)

- L01EK
- L01EK04

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4303214)

## Regulatory information

### United States

**Applicant**

TAKEDA PHARMS USA

**Approval date**

8 Nov 2023

**Application number**

NDA217564

### European Union

**Status**

Authorised

**Status date**

20 Jun 2024

**Authorisation date**

20 Jun 2024

**Approved indications**

Fruzaqla as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF agents, and anti EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine tipiracil or regorafenib.

**Product number**

EMEA/H/C/005979

**Authorisation holder**

Takeda Pharmaceuticals International AG Ireland

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

Yes

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Colorectal Neoplasms

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/fruzaqla)

### Other regulatory facts

**Patents**

4

**Designations**

2

**Earliest recorded loss of exclusivity**

7 Sept 2035

**First in class**

No

**Fast track**

Yes

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

Yes

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

fruquintinib

**Type**

Synthetic organic

**Drug name stem**

\-tinib

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (6)

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
fms related receptor tyrosine kinase 1

**Gene symbol**  
FLT1

**Protein identifier**  
P17948

**Median affinity**

7.48

**Affinity units**  
pIC50

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

**Action type**  
Inhibitor

**Target**  
fms related receptor tyrosine kinase 4

**Gene symbol**  
FLT4

**Protein identifier**  
P35916

**Median affinity**

9.3

**Affinity units**  
pIC50

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

**Action type**  
Inhibitor

**Target**  
kinase insert domain receptor

**Gene symbol**  
KDR

**Protein identifier**  
P35968

**Median affinity**

7.6

**Affinity units**  
pIC50

**Primary target**  
Yes
- **Mechanism**  
Vascular endothelial growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Vascular endothelial growth factor receptor

**Protein identifier**  
P17948
- **Mechanism**  
Vascular endothelial growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Vascular endothelial growth factor receptor

**Protein identifier**  
P35916
- **Mechanism**  
Vascular endothelial growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Vascular endothelial growth factor receptor

**Protein identifier**  
P35968

### Open Targets mechanisms

- **Mechanism**  
Vascular endothelial growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Vascular endothelial growth factor receptor

### Investigated indications (21)

- **Condition**  
Carcinoma, Hepatocellular

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000182

**Subject identifier**  
D006528
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000365

**Subject identifier**  
D015179
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Carcinoma, Renal Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000681

**Subject identifier**  
D002292
- **Condition**  
Liver Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001421

**Subject identifier**  
D008107
- **Condition**  
Pancreatic Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0002618

**Subject identifier**  
D010190
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Kidney Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003086

**Subject identifier**  
D007674
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003897

**Subject identifier**  
D013274
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0004142

**Subject identifier**  
D015179
- **Condition**  
Esophageal Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005922

**Subject identifier**  
D004938
- **Condition**  
Rectal Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000657

**Subject identifier**  
D012004
- **Condition**  
Sarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1001968

**Subject identifier**  
D012509
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0001056

**Subject identifier**  
D013274
- **Condition**  
Adenocarcinoma

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0003219

**Subject identifier**  
D000230
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0005575

**Subject identifier**  
D015179
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Lung Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0008903

**Subject identifier**  
D008175
- **Condition**  
Endometrial Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0011962

**Subject identifier**  
D016889
- **Condition**  
Colonic Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0021063

**Subject identifier**  
D003110

### Open Targets indications (54)

- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000681
- **Condition identifier**  
EFO\_0000756
- **Condition identifier**  
EFO\_0001421

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0002618

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003060

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0003086

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003897
- **Condition identifier**  
EFO\_0004142
- **Condition identifier**  
EFO\_0005922

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1000657
- **Condition identifier**  
EFO\_1001480

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001480

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1001951

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

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0001056

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0002691

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0003060

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0003219

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0003219

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0004992
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005005

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005008

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005036

**Highest recorded phase**  
3

And 29 more, listed on the interactive page.

### Reported adverse events (7)

- **Event**  
colorectal cancer recurrent

**Reports**  
1

**Reporting signal score**

8.56296
- **Event**  
hyperplastic cholecystopathy

**Reports**  
1

**Reporting signal score**

8.33057
- **Event**  
milia

**Reports**  
1

**Reporting signal score**

7.8767
- **Event**  
proteinuria

**Reports**  
2

**Reporting signal score**

7.9142
- **Event**  
rash

**Reports**  
4

**Reporting signal score**

8.09473
- **Event**  
thymus disorder

**Reports**  
1

**Reporting signal score**

8.02187
- **Event**  
thymus enlargement

**Reports**  
1

**Reporting signal score**

7.9911

### Trial references (61)

- NCT01645215  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01645215)
- NCT03903705  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03903705)
- NCT04577963  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04577963)
- NCT04716634  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04716634)
- NCT01975077  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01975077)
- NCT02196688  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02196688)
- NCT02314819  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02314819)
- NCT04179084  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04179084)
- NCT04296019  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04296019)
- NCT04695470  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04695470)
- NCT04733963  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04733963)
- NCT05025631  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05025631)
- NCT05435313  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05435313)
- NCT05451719  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05451719)
- NCT05511051  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05511051)
- NCT05771181  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05771181)
- NCT05954429  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05954429)
- NCT06010888  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06010888)
- NCT06168786  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168786)
- NCT06199973  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06199973)
- NCT06218888  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06218888)
- NCT06356597  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06356597)
- NCT06441565  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06441565)
- NCT02415023  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02415023)
- NCT05177068  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05177068)

And 36 more, listed on the interactive page.

## Dosing

**Dose**

5 mg

**Route**

Oral

**How often**

Once daily

### Conditions of use (2)

- Swallow capsule whole
- Take with or without food

## Chemical properties

**Hydrogen bond acceptors**

7

**Hydrogen bond donors**

1

**Polar surface area**

95.71

**Calculated partition coefficient (ALogP)**

3.85

**Calculated partition coefficient (XLogP)**

3.4

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

5

**Heavy atoms**

29

**Molecular formula**

C21H19N3O5

**Monoisotopic mass**

393.13247072

**Natural product**

Yes

## National Drug Codes

- 63020-210
- 63020-225

## Evidence counts

**Recorded assays**

246

**Active assays**

17

### Active assay types (2)

- Confirmatory
- Other

## Pharmacologic actions

- Tyrosine Kinase Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000092004.html)
- Antineoplastic Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000970.html)

## Related records

### Trials (166)

- - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases
- : A Phase Ib/II Study To Evaluate Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors
- A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer
- A Clinical Study on the Efficacy and Safety of Fruquintinib in Combination With PD-1 Monoclonal Antibody and Chidamide in Refractory MSS Metastatic Colorectal Cancer
- A Clinical Study to Evaluate Injection TQB2102 for the Treatment of Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Progressed After Treatment With Oxaliplatin, Irinotecan and Fluoropyrimidine-Based Drugs
- A Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer
- A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion Of \[14C\] Fruquintinib
- A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers
- A Multicenter, Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of Concurrent Combination Therapy of S-531011 Plus Fruquintinib or S-531011 Plus Fruquintinib Plus Pembrolizumab in Patients With MSS/pMMR Colorectal Cancer
- A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
- A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
- A Phase Ib Study of Fruquintinib in 3rd Line mCRC
- A Phase Ib/2 Clinical Study of Fruquintinib Combined With Paclitaxel in the Treatment of Advanced Gastric Cancer
- [A Phase Ib/II Clinical Study of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma](https://trialight.com/data/trial/a-phase-ib-ii-clinical-study-of-lbl-024-combination-therapy-86e4e228-c1ab-4727-862f-668d70ded13d.md)
- A Phase Ib/II Study of HDM2017 in Combination With Standard of Care in Advanced Colorectal Cancer
- A Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Fruquintinib in the Treatment of Immunodominant pMMR/MSS Metastatic Colorectal Cancer That Has Failed Second-line or Above Treatment
- A Phase II Clinical Study of Fruquintinib Combined With RC48 in the Treatment of Previously Treated HER2-positive Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (G/GEJ) Cancer
- A Phase II Clinical Study of Fruquintinib Combined With S-1 for Advanced Esophageal Squamous Cell Carcinoma
- A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver Metastases
- A Phase II Clinical Trial of Fruquintinib as Third Line Treatment in Advanced Pancreatic Cancer

### Approved for (5)

- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md)
- [Colorectal adenocarcinoma](https://trialight.com/data/condition/colorectal-adenocarcinoma-49107d5a-ece1-5f2b-8783-f2077e298ffa.md)
- [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md)
- [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md)
- Neoplasm

### In development for (17)

- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 1
- [Colorectal carcinoma](https://trialight.com/data/condition/colorectal-carcinoma-51401c02-7884-5c5c-bb91-90106e7d0d4a.md) Phase 2
- [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) Phase 1
- [Esophageal squamous cell carcinoma](https://trialight.com/data/condition/esophageal-squamous-cell-carcinoma-c10bd9c9-02f9-5805-8008-b021f4604e7a.md) Phase 2
- Exocrine pancreatic carcinoma Phase 2
- [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 3
- [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) Phase 3
- [Gastroesophageal junction adenocarcinoma](https://trialight.com/data/condition/gastroesophageal-junction-adenocarcinoma-de7e280e-cbd1-5266-a5dd-dda00261a706.md) Phase 1
- [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Phase 2
- [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md) Phase 1
- [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1
- [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 2
- Malignant colon neoplasm Phase 2
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 3
- Rectal cancer Phase 2
- [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) Phase 2
- [Soft tissue sarcoma](https://trialight.com/data/condition/soft-tissue-sarcoma-3abd95b0-f8eb-5f0b-9e18-b37874e7f988.md) Phase 2

### Other linked conditions (2)

- [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md)
- Nonpapillary renal cell carcinoma

### Targets (3)

- [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md) Vascular endothelial growth factor receptor inhibitor
- [FLT4](https://trialight.com/data/target/flt4-c94058e2-ff1e-553b-92a5-8e7ee9305a80.md) Vascular endothelial growth factor receptor inhibitor
- [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) Vascular endothelial growth factor receptor inhibitor

---

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