> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/sotorasib-a4359290-f99a-4ef1-8cd1-9a866e8b0748
> Record changed: 2026-10-13

# Sotorasib

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

First approval year

2021

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

## Development status

**First approval year**

2021

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

**Drug name**

Sotorasib

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

**Molecular weight**

560.61

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

**Structure (SMILES)**

C=CC(=O)N1CCN(c2nc(=O)n(-c3c(C)ccnc3C(C)C)c3nc(-c4c(O)cccc4F)c(F)cc23)\[C@@H\](C)C1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

### Brand names (4)

- lumakras
- Lumakras
- lumykras
- Lumykras

### Other names (39)

- (R)-38
- (S)-AMG-510
- amg 510
- AMG 510
- AMG-510
- amg510
- AMG510
- ct amg510amg 510amg510
- CT-AMG510AMG-510AMG510
- kras g12c inhibitor 9
- Kras g12c inhibitor 9
- KRAS G12C INHIBITOR 9
- kras mutant targeting amg 510
- Kras mutant-targeting amg 510
- KRAS MUTANT-TARGETING AMG 510
- lumakras
- LUMAKRAS
- lumykras
- LUMYKRAS
- r 38
- s amg 510
- sotorasib
- Sotorasib
- SOTORASIB
- SOTORASIB (AMG510) RACEMATE

And 14 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- L01XX73

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

**CAS registry numbers**

- 2296729-00-3

**ChEMBL ID**

CHEMBL4535757

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

**InChIKey**

NXQKSXLFSAEQCZ-SFHVURJKSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4535757)

**PubChem compound IDs**

- 137278711

**RxNorm IDs (RxCUI)**

- 2550714

**FDA ingredient codes (UNII)**

- 2B2VM6UC8G

## Regulatory information

### United States

**Applicant**

AMGEN INC

**Approval date**

28 May 2021

**Application number**

NDA214665

### European Union

**Status**

Authorised

**Status date**

6 Jan 2022

**Authorisation date**

6 Jan 2022

**Approved indications**

Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.

**Product number**

EMEA/H/C/005522

**Authorisation holder**

Amgen Europe B.V.

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

Yes

**Additional monitoring**

Yes

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Carcinoma, Non-Small-Cell Lung

European medicines record

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

### Other regulatory facts

**Patents**

6

**Designations**

8

**Earliest recorded loss of exclusivity**

15 Sept 2040

**First in class**

Yes

**Fast track**

Yes

**Breakthrough designation**

Yes

**Orphan designation**

No

**Priority review**

Yes

**Orphan exclusivity**

No

**Accelerated approval**

Yes

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

sotorasib

**Type**

Synthetic organic

**Drug name stem**

\-rasib

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (2)

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
KRAS

**Gene symbol**  
KRAS

**Protein identifier**  
P01116

**Median affinity**

10.39

**Affinity units**  
pKi
- **Mechanism**  
GTPase KRas inhibitor

**Action type**  
Inhibitor

**Target**  
GTPase KRas

**Protein identifier**  
P01116

### Open Targets mechanisms

- **Mechanism**  
GTPase KRas inhibitor

**Action type**  
Inhibitor

**Target**  
GTPase KRas

### DrugCentral mechanisms

- **Action type**  
Inhibitor

**Gene symbol**  
KRAS

**Protein identifier**  
P01116

**Organism**  
Homo sapiens

**Target development level**  
Chemical evidence

### Investigated indications (7)

- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Ovarian Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0001075

**Subject identifier**  
D010051
- **Condition**  
Liver Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001421

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

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0002618

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

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0003060

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

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0005575

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

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0008903

**Subject identifier**  
D008175

### Open Targets indications (21)

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

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003060
- **Condition identifier**  
EFO\_0003833

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_1000044

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

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

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005008

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

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005192

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005233

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005575

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0006047

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0007254

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

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0008903

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0009831

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0011962

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0021211

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0021350

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0056806

**Highest recorded phase**  
2

### Reported adverse events (2)

- **Event**  
non-small cell lung cancer

**Reports**  
12

**Reporting signal score**

69.6457
- **Event**  
non-small cell lung cancer metastatic

**Reports**  
2

**Reporting signal score**

12.0295

### Trial references (31)

- NCT03600883  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03600883)
- NCT04092673  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04092673)
- NCT04185883  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04185883)
- NCT04380753  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04380753)
- NCT05638295  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05638295)
- NCT04303780  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04303780)
- NCT04625647  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04625647)
- NCT04720976  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04720976)
- NCT04933695  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04933695)
- NCT04959981  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04959981)
- NCT05054725  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05054725)
- NCT05180422  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05180422)
- NCT05311709  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05311709)
- NCT05313009  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05313009)
- NCT05374538  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05374538)
- NCT05398094  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05398094)
- NCT05400577  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05400577)
- NCT05451056  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05451056)
- NCT05480865  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05480865)
- NCT05631249  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05631249)
- NCT05815173  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815173)
- NCT05815186  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05815186)
- NCT06068153  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06068153)
- NCT06249282  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06249282)
- NCT06333678  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06333678)

And 6 more, listed on the interactive page.

## Dosing

**Dose**

960 mg

**Route**

Orally

**How often**

Once daily

### Conditions of use (2)

- Swallow tablets whole
- Take with or without food

## Chemical properties

**Hydrogen bond acceptors**

8

**Hydrogen bond donors**

1

**Polar surface area**

104.45

**Calculated partition coefficient (ALogP)**

4.48

**Calculated partition coefficient (XLogP)**

4

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

5

**Heavy atoms**

41

**Molecular formula**

C30H30F2N6O3

**Monoisotopic mass**

560.23474516

**Natural product**

No

## National Drug Codes

- 55513-488
- 55513-504
- 55513-512

## Evidence counts

**Recorded assays**

302

**Active assays**

49

### Active assay types

- Confirmatory

## Pharmacologic actions

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

## Biological measurements

These details could not be displayed.

## Related records

### Trials (68)

- A 2-part Phase 1/2 Open-label Trial on ODM-212
- A Clinical Trial to Evaluate Bioavailability and Effect of Food for Sotorasib in Healthy Participants
- [A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors](https://trialight.com/data/trial/a-first-in-human-fih-study-to-evaluate-the-safety-and-6675542e-45b5-40e0-a6e8-8a1e82cb3724.md)
- A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
- A Phase 2 Basket Trial in Which Patients With Advanced Solid Tumors Carrying the KRAS G12C mUtation Receive Treatment With a Combination of Sotorasib and Panitumumab
- A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis
- A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation
- A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
- A Study Comparing Sotorasib With Durvalumab in People With Non-Small Cell Lung Cancer (NSCLC)
- A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
- A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer
- [A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets](https://trialight.com/data/trial/a-study-in-healthy-volunteers-to-compare-the-721799d5-a4cc-454d-bdb5-ebdd91f826b5.md)
- A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Advanced NSCLC
- A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
- A Study of Sotorasib in People With Brain Tumors
- A Study of Sotorasib in People With Non-Small Cell Lung Cancer
- A Study of the Absorption, Metabolism, and Excretion of \[14C\]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
- A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
- A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants
- A Study to Evaluate the Drug-drug Interaction Effect of Itraconazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

### Approved for (2)

- Neoplasm
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md)

### In development for (7)

- [Brain neoplasm](https://trialight.com/data/condition/brain-neoplasm-b3dac71b-1d7b-5a65-8f64-89821506ad41.md) Phase 1
- [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 3
- Exocrine pancreatic carcinoma 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
- Ovarian carcinoma Phase 2
- [Pancreatic adenocarcinoma](https://trialight.com/data/condition/pancreatic-adenocarcinoma-fd65444c-0bc5-53ed-8c6a-62d9809145d0.md) Phase 2

### Targets (1)

- [KRAS](https://trialight.com/data/target/kras-106a796f-110c-5472-9254-9049150fe0f1.md) GTPase KRas inhibitor

---

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