> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/fianlimab-90c791f8-25bd-4882-8311-8dd34d92ebc7
> Record changed: 2026-10-13

# Fianlimab

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298085)

Drug type

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298085)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298085)

## Names and chemistry

**Drug type**

Antibody

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298085)

**Drug name**

Fianlimab

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298085)

### Other names (19)

- anti lag 3 monoclonal antibody regn3767
- ANTI-LAG-3 MONOCLONAL ANTIBODY REGN3767
- cemiplimab and fianlimab
- fianlimab
- Fianlimab
- fianlimab \[INN\]
- FIANLIMAB \[USAN\]
- Fianlimab \[WHO-DD\]
- Fianlimab 1600 MG Intravenous Solution
- fianlimab inn
- fianlimab usan
- fianlimab who dd
- recombinant human igg4 kappa anti lag 3 monoclonal antibody regn3767
- RECOMBINANT HUMAN IgG4 KAPPA ANTI LAG-3 MONOCLONAL ANTIBODY REGN3767
- regn 3767
- REGN-3767
- regn3767
- Regn3767
- REGN3767

## Identifiers

**CAS registry numbers**

- 2126132-98-5

**ChEMBL ID**

CHEMBL4298085

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4298085)

**FDA ingredient codes (UNII)**

- OX5LRQ5H6K

## Regulatory information

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

## Pharmacology

### Drug classification

**Pharmacology name**

fianlimab

**Type**

Antibody

**Drug name stem**

\-mab

### Mechanisms of action (2)

- **Action**  
Binding

**Action type**  
Binding

**Target**  
LAG3 (CD223)

**Gene symbol**  
LAG3

**Protein identifier**  
P18627

**Median affinity**

8.49

**Affinity units**  
pKd
- **Mechanism**  
Lymphocyte activation gene 3 protein inhibitor

**Action type**  
Inhibitor

**Target**  
Lymphocyte activation gene 3 protein

**Protein identifier**  
P18627

### Open Targets mechanisms

- **Mechanism**  
Lymphocyte activation gene 3 protein inhibitor

**Action type**  
Inhibitor

**Target**  
Lymphocyte activation gene 3 protein

### Investigated indications (11)

- **Condition**  
Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000616

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

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000756

**Subject identifier**  
D008545
- **Condition**  
Multiple Myeloma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001378

**Subject identifier**  
D009101
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003869

**Subject identifier**  
D001943
- **Condition**  
Hemangiosarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003968

**Subject identifier**  
D006394
- **Condition**  
Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0005233

**Subject identifier**  
D002289
- **Condition**  
Colorectal Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0005575

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

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Prostatic Neoplasms, Castration-Resistant

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0008315

**Subject identifier**  
D064129

### Open Targets indications (27)

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

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1001927

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001950

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002367

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002715

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0003308

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004986

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

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005005

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005070
- **Condition identifier**  
MONDO\_0005086

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005105

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005233

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005575

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005627

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0006519

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0007256

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0008170

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0008315

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0008903

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0009693

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

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0016698

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0020804

**Highest recorded phase**  
2

And 2 more, listed on the interactive page.

### Reported adverse events

- **Event**  
adrenal insufficiency

**Reports**  
3

**Reporting signal score**

15.1528

### Trial references (13)

- NCT01042379  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01042379)
- NCT03005782  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03005782)
- NCT03233139  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03233139)
- NCT04989946  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04989946)
- NCT05137054  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05137054)
- NCT05352672  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05352672)
- NCT05608291  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05608291)
- NCT06190951  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06190951)
- NCT06246916  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06246916)
- NCT05785767  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05785767)
- NCT05800015  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05800015)
- NCT06161441  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06161441)
- NCT06205836  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06205836)

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

### Sequences (5)

- **Component**  
Heavy chain

**Type**  
Protein

**Sequence**  
QVQLVESGGGVVQPGRSLRLSCVASGFTFSSYGMHWVRQAPGKGLEWVAIIWYDGSNKYYADSVKGRFTISRDNSKNTQYLQMNSLRAEDTAVYYCASVATSGDFDYYGMDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- **Component**  
Light chain

**Type**  
Protein

**Sequence**  
EIVLTQSPATLSLSPGERTTLSCRASQRISTYLAWYQQKPGQAPRLLIYDASKRATGIPARFSGSGSGTGFTLTISSLEPEDFAVYYCQQRSNWPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- **Component**  
Glycosylation sites (N)

**Sequence**  
Asn299 $ Asn299''
- **Component**  
Disulfide bridges

**Sequence**  
22-96 $ 22''-96'' $ 23'-88' $ 23'''-88''' $ 134'-194' $ 134'''-194''' $ 137-214' $ 137''-214''' $ 150-206 $ 150''-206'' $ 229-229'' $ 232-232'' $ 263-323 $ 263''-323'' $ 369-427 $ 369''-427''
- **Component**  
Glycosylation sites (N)

**Sequence**  
Asn299 $ Asn299'

## Related records

### Trials (41)

- A Phase II Platform Study to Evaluate Treatment With Cemiplimab Monotherapy or Cemiplimab Plus Fianlimab or Other Novel Combinations in Patients With Colorectal Cancer With Minimal Residual Disease Following Definitive Surgery and Chemotherapy (EMPIRE)
- A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
- A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma or Posterior Fossa-A Ependymoma
- A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment
- A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma
- A Study of Cemiplimab and Fianlimab in People With Nasopharyngeal Carcinoma
- A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma
- A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer
- [A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments](https://trialight.com/data/trial/a-study-to-examine-the-effects-of-novel-therapy-4622f07a-ab31-4a56-a46c-08b2e34a9258.md)
- A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
- A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
- A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
- A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
- A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
- A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
- A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer
- A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
- A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery
- [A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery](https://trialight.com/data/trial/a-trial-to-see-if-the-combination-of-fianlimab-with-35e5fcec-0f47-4d57-b44f-9c845050330d.md)
- Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer

### In development for (12)

- Angiosarcoma Phase 2
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2
- [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 2
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 1
- Colon carcinoma Phase 2
- [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 2
- Malignant colon neoplasm Phase 2
- [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Phase 3
- Neoplasm Phase 1
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 2
- [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Phase 1
- [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Phase 1

### Targets (1)

- [LAG3](https://trialight.com/data/target/lag3-9427165f-23d0-56e2-8aec-0a1f9a15edc3.md) Lymphocyte activation gene 3 protein inhibitor

---

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