> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/infigratinib-b1c6e5c1-3ef7-43c1-9ca6-e86656a1dcd3
> Record changed: 2026-11-04

# Infigratinib

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

First approval year

2021

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

## Development status

**First approval year**

2021

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

**Drug name**

Infigratinib

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

**Molecular weight**

560.49

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

**Structure (SMILES)**

CCN1CCN(c2ccc(Nc3cc(N(C)C(=O)Nc4c(Cl)c(OC)cc(OC)c4Cl)ncn3)cc2)CC1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

### Other names (32)

- bgj 398
- Bgj-398
- BGJ-398
- bgj398
- BGJ398
- BGJ398 (NVP-BGJ398)
- BGJ398 (NVP-BGJ398|INFIGRATINIB)
- bgj398 nvp bgj398
- bgj398 nvp bgj398 infigratinib
- infigratinib
- Infigratinib
- INFIGRATINIB
- INFIGRATINIB (BGJ398)
- infigratinib \[INN\]
- Infigratinib \[MI\]
- INFIGRATINIB \[USAN\]
- Infigratinib \[WHO-DD\]
- infigratinib bgj398
- infigratinib inn
- infigratinib mi
- infigratinib usan
- infigratinib who dd
- kin001 271
- KIN001-271
- mvp bgj398

And 7 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 872511-34-7

**ChEMBL ID**

CHEMBL1852688

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

**InChIKey**

QADPYRIHXKWUSV-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

**PubChem compound IDs**

- 53235510

**RxNorm IDs (RxCUI)**

- 2550729

**FDA ingredient codes (UNII)**

- A4055ME1VK

### ATC classification codes (2)

- L01E
- L01EN03

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1852688)

## Regulatory information

### United States

**Applicant**

HELSINN HLTHCARE

**Approval date**

28 May 2021

**Application number**

NDA214622

### European Union

**Status**

application\_withdrawn

**Status date**

11 Oct 2022

**Approved indications**

Treatment of cholangiocarcinoma.

**Product number**

EMEA/H/C/005361

**Authorisation holder**

Helsinn Birex Pharmaceuticals Ltd

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

No

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Cholangiocarcinoma

European medicines record

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

### Other regulatory facts

**Patents**

0

**Designations**

5

**First in class**

No

**Fast track**

Yes

**Breakthrough designation**

No

**Orphan designation**

Yes

**Priority review**

Yes

**Orphan exclusivity**

No

**Accelerated approval**

Yes

**Availability**

discontinued

## Approval status

**United States (FDA)**

Approved

**European Union (EMA)**

Application withdrawn

## Pharmacology

### Drug classification

**Pharmacology name**

infigratinib

**Type**

Synthetic organic

**Drug name stem**

\-tinib

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (9)

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
fibroblast growth factor receptor 1

**Gene symbol**  
FGFR1

**Protein identifier**  
P11362

**Median affinity**

9.05

**Affinity units**  
pIC50

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

**Action type**  
Inhibitor

**Target**  
fibroblast growth factor receptor 2

**Gene symbol**  
FGFR2

**Protein identifier**  
P21802

**Median affinity**

8.85

**Affinity units**  
pIC50

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

**Action type**  
Inhibitor

**Target**  
fibroblast growth factor receptor 4

**Gene symbol**  
FGFR4

**Protein identifier**  
P22455

**Median affinity**

7.22

**Affinity units**  
pIC50
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
fibroblast growth factor receptor 3

**Gene symbol**  
FGFR3

**Protein identifier**  
P22607

**Median affinity**  
9

**Affinity units**  
pIC50

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

**Action type**  
Inhibitor

**Target**  
kinase insert domain receptor

**Gene symbol**  
KDR

**Protein identifier**  
P35968

**Median affinity**

6.74

**Affinity units**  
pIC50
- **Mechanism**  
Fibroblast growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Fibroblast growth factor receptor

**Protein identifier**  
P11362
- **Mechanism**  
Fibroblast growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Fibroblast growth factor receptor

**Protein identifier**  
P21802
- **Mechanism**  
Fibroblast growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Fibroblast growth factor receptor

**Protein identifier**  
P22455
- **Mechanism**  
Fibroblast growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Fibroblast growth factor receptor

**Protein identifier**  
P22607

### Open Targets mechanisms

- **Mechanism**  
Fibroblast growth factor receptor inhibitor

**Action type**  
Inhibitor

**Target**  
Fibroblast growth factor receptor

### DrugCentral mechanisms (5)

- **Action type**  
Inhibitor

**Gene symbol**  
FGFR1

**Protein identifier**  
P11362

**Organism**  
Homo sapiens

**Target development level**  
Clinical
- **Action type**  
Inhibitor

**Gene symbol**  
FGFR2

**Protein identifier**  
P21802

**Organism**  
Homo sapiens

**Target development level**  
Clinical
- **Action type**  
Inhibitor

**Gene symbol**  
FGFR4

**Protein identifier**  
P22455

**Organism**  
Homo sapiens

**Target development level**  
Clinical
- **Action type**  
Inhibitor

**Gene symbol**  
FGFR3

**Protein identifier**  
P22607

**Organism**  
Homo sapiens

**Target development level**  
Clinical
- **Action type**  
Inhibitor

**Gene symbol**  
KDR

**Protein identifier**  
P35968

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (15)

- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000181

**Subject identifier**  
D002294
- **Condition**  
Glioblastoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000519

**Subject identifier**  
D005909
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Melanoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000756

**Subject identifier**  
D008545
- **Condition**  
Uterine Cervical Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001061

**Subject identifier**  
D002583
- **Condition**  
Papillomavirus Infections

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0001668

**Subject identifier**  
D030361
- **Condition**  
Cholangiocarcinoma

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0005221

**Subject identifier**  
D018281
- **Condition**  
Paraganglioma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000453

**Subject identifier**  
D010235
- **Condition**  
Osteomalacia

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1002027

**Subject identifier**  
D010018
- **Condition**  
Urinary Bladder Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0001187

**Subject identifier**  
D001749
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Achondroplasia

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0007037

**Subject identifier**  
D000130
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Gastrointestinal Stromal Tumors

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0011719

**Subject identifier**  
D046152
- **Condition**  
Squamous Cell Carcinoma of Head and Neck

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0044704

**Subject identifier**  
D000077195

### Open Targets indications (36)

- **Condition identifier**  
EFO\_0000181

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000519

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0001668

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0005221
- **Condition identifier**  
EFO\_1000453

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1002027

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0000448

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0001056

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0001187

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0001187

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0003210

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

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005070

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005105

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005131

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005184

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005611
- **Condition identifier**  
MONDO\_0007037

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0007254

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0007793

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0009831

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0010150

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0011719

And 11 more, listed on the interactive page.

### Trial references (18)

- NCT01697605  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01697605)
- NCT01928459  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01928459)
- NCT02160041  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02160041)
- NCT01975701  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01975701)
- NCT04424966  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04424966)
- NCT02150967  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02150967)
- NCT03773302  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03773302)
- NCT04233567  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04233567)
- NCT05510427  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05510427)
- NCT02159066  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02159066)
- NCT02257541  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02257541)
- NCT02312804  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02312804)
- NCT02706691  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02706691)
- NCT03510455  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03510455)
- NCT04197986  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04197986)
- NCT04265651  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04265651)
- NCT05145010  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05145010)
- NCT04504331  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04504331)

## Chemical properties

**Hydrogen bond acceptors**

8

**Hydrogen bond donors**

2

**Polar surface area**

95.09

**Calculated partition coefficient (ALogP)**

5.35

**Calculated partition coefficient (XLogP)**

4.7

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

2

**Rotatable bonds**

8

**Heavy atoms**

38

**Molecular formula**

C26H31Cl2N7O3

**Monoisotopic mass**

559.1865433

**Natural product**

Yes

## Evidence counts

**Recorded assays**

1,551

**Active assays**

226

### Active assay types (2)

- Confirmatory
- Other

## Pharmacologic actions

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

## Related records

### Trials (30)

- A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
- A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
- A Phase I Study of Oral BGJ398 in Asian Patients
- A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
- A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia
- An Interventional Study of Infigratinib in Children With Hypochondroplasia
- BGJ398 for Patients With Tumors With FGFR Genetic Alterations
- BGJ398 for the Treatment of Tumor-Induced Osteomalacia
- BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST)
- BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder
- BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer
- Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma
- [Extension Study of Infigratinib in Children With Achondroplasia (ACH)](https://trialight.com/data/trial/extension-study-of-infigratinib-in-children-with-905a6a7c-677b-45d6-b98c-991c09274af7.md)
- Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer
- Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations
- Infigratinib in Recurrent High-Grade Glioma Patients
- Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations
- Interventional Study of Infigratinib in Children < 3 Years Old With Achondroplasia (ACH)
- LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma
- Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia

### Approved for (2)

- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md)
- [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md)

### In development for (25)

- [Achondroplasia](https://trialight.com/data/condition/achondroplasia-30f8e5ac-f6be-5f3c-9878-8fd830eb5505.md) Phase 2
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 1
- [Cervical carcinoma](https://trialight.com/data/condition/cervical-carcinoma-fe520bb0-bc93-5cf1-a9ee-5a3ce33f2fdd.md) Phase 1
- [Cholangiocarcinoma](https://trialight.com/data/condition/cholangiocarcinoma-3777afe4-5189-5eb1-82f8-0c3446cb902f.md) Phase 3
- [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 2
- [Gastroesophageal junction adenocarcinoma](https://trialight.com/data/condition/gastroesophageal-junction-adenocarcinoma-de7e280e-cbd1-5266-a5dd-dda00261a706.md) Phase 2
- [Gastrointestinal stromal tumor](https://trialight.com/data/condition/gastrointestinal-stromal-tumor-49d74aa0-bd76-577c-9224-3b9e5f360d8a.md) Phase 1
- Glioblastoma Phase 2
- [Glioma](https://trialight.com/data/condition/glioma-4ac240c4-7ffb-5f08-b793-0b205a4b5d03.md) Phase 2
- [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) Phase 2
- [Hematopoietic and lymphoid cell neoplasm](https://trialight.com/data/condition/hematopoietic-and-lymphoid-cell-neoplasm-ed3616fa-22fe-5984-94b4-745416e01ef9.md) Phase 2
- [Human papilloma virus infection](https://trialight.com/data/condition/human-papilloma-virus-infection-e1703022-65c5-5d5f-a4b3-a2a98325eeeb.md) Phase 2
- Hypochondroplasia Phase 2
- Intrahepatic cholangiocarcinoma Phase 2
- [Low grade glioma](https://trialight.com/data/condition/low-grade-glioma-52448124-756a-5233-8692-49c9a875186e.md) Phase 1
- [Malignant pancreatic neoplasm](https://trialight.com/data/condition/malignant-pancreatic-neoplasm-5dd0b53e-5962-50ea-a2e5-cf2444bd0485.md) Phase 1
- [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Phase 2
- Oropharynx squamous cell carcinoma Phase 2
- Osteomalacia Phase 2
- [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) Phase 1

### Other linked conditions (1)

- Bladder transitional cell carcinoma

### Targets (5)

- [FGFR1](https://trialight.com/data/target/fgfr1-4e918a87-4309-5610-93c5-066e5125172c.md) Fibroblast growth factor receptor inhibitor
- [FGFR2](https://trialight.com/data/target/fgfr2-fe40fa89-06a8-5027-ad17-dc2ec2e9ebcd.md) Fibroblast growth factor receptor inhibitor
- [FGFR3](https://trialight.com/data/target/fgfr3-363bb275-8462-51a9-af1c-c621c347ca84.md) Fibroblast growth factor receptor inhibitor
- [FGFR4](https://trialight.com/data/target/fgfr4-38e1dfb6-08fc-5ac7-af16-77d02fe78df0.md) Fibroblast growth factor receptor inhibitor
- [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md)

---

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