> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/dalpiciclib-2001da9e-4c75-4a18-ae80-97f8c567dba5
> Record changed: 2026-10-13

# Dalpiciclib

Highest phase reached

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4802161)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4802161)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 3

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4802161)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4802161)

**Drug name**

Dalpiciclib

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4802161)

**Molecular weight**

446.56

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4802161)

**Structure (SMILES)**

CC(=O)c1c(C)c2cnc(Nc3ccc(C4CCNCC4)cn3)nc2n(C2CCCC2)c1=O

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4802161)

### Other names (17)

- adebrelimab and dalpiciclib
- cdk4 6 inhibitor shr6390
- CDK4/6 INHIBITOR SHR6390
- dalpiciclib
- Dalpiciclib
- dalpiciclib \[INN\]
- Dalpiciclib \[WHO-DD\]
- Dalpiciclib 100mg
- Dalpiciclib 125mg
- Dalpiciclib 150mg
- dalpiciclib inn
- dalpiciclib who dd
- pyrido 2 3 d pyrimidin 7 8h one 6 acetyl 8 cyclopentyl 5 methyl 2 5 4 piperidinyl 2 pyridinyl amino
- PYRIDO(2,3-D)PYRIMIDIN-7(8H)-ONE, 6-ACETYL-8-CYCLOPENTYL-5-METHYL-2-((5-(4-PIPERIDINYL)-2-PYRIDINYL)AMINO)-
- shr 6390
- Shr-6390
- SHR-6390

## Identifiers

**CAS registry numbers**

- 1637781-04-4

**ChEMBL ID**

CHEMBL4802161

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4802161)

**InChIKey**

SGJLSPUSUBJWHO-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4802161)

**PubChem compound IDs**

- 86279927

**FDA ingredient codes (UNII)**

- 5ZHA5P4PFX

## Regulatory information

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

## Pharmacology

### Drug classification

**Pharmacology name**

dalpiciclib

**Type**

Synthetic organic

**Drug name stem**

\-ciclib

**Approval recorded by Guide to Pharmacology**

Yes

### Mechanisms of action (2)

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
cyclin dependent kinase 4

**Gene symbol**  
CDK4

**Protein identifier**  
P11802

**Median affinity**

7.96

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

**Action type**  
Inhibitor

**Target**  
cyclin dependent kinase 6

**Gene symbol**  
CDK6

**Protein identifier**  
Q00534

**Median affinity**

8.22

**Affinity units**  
pIC50

### Investigated indications (12)

- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000181

**Subject identifier**  
D002294
- **Condition**  
Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Sarcoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000691

**Subject identifier**  
D012509
- **Condition**  
Melanoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000756

**Subject identifier**  
D008545
- **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**  
2

**Condition identifier**  
EFO:0002618

**Subject identifier**  
D010190
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0003869

**Subject identifier**  
D001943
- **Condition**  
Esophageal Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005922

**Subject identifier**  
D004938
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0001056

**Subject identifier**  
D013274
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Nasopharyngeal Carcinoma

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0015459

**Subject identifier**  
D000077274

### Open Targets indications (27)

- **Condition identifier**  
EFO\_0000181

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

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000691

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

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0001075

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001421

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

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0003869

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0005922

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

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004950

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004990

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

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

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

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005233

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005494
- **Condition identifier**  
MONDO\_0005575

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005580

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0007254

**Highest recorded phase**  
3
- **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**  
2
- **Condition identifier**  
MONDO\_0010150

**Highest recorded phase**  
2

And 2 more, listed on the interactive page.

### Trial references (44)

- NCT02671513  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02671513)
- NCT02684266  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02684266)
- NCT05512780  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05512780)
- NCT03480256  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03480256)
- NCT03481998  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03481998)
- NCT03772353  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03772353)
- NCT03927456  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03927456)
- NCT04095390  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04095390)
- NCT04236310  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04236310)
- NCT04293276  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04293276)
- NCT04355858  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04355858)
- NCT04733417  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04733417)
- NCT04842617  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04842617)
- NCT04997798  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04997798)
- NCT05176080  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05176080)
- NCT05431504  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05431504)
- NCT05463601  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05463601)
- NCT05469750  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05469750)
- NCT05512416  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05512416)
- NCT05515289  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05515289)
- NCT05574881  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05574881)
- NCT05577923  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05577923)
- NCT05586841  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05586841)
- NCT05638594  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05638594)
- NCT05759546  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05759546)

And 19 more, listed on the interactive page.

## Chemical properties

**Hydrogen bond acceptors**

8

**Hydrogen bond donors**

2

**Polar surface area**

101.8

**Calculated partition coefficient (ALogP)**

4.02

**Calculated partition coefficient (XLogP)**

2.5

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

5

**Heavy atoms**

33

**Molecular formula**

C25H30N6O2

**Monoisotopic mass**

446.24302422

**Natural product**

No

## Evidence counts

**Recorded assays**

5

**Active assays**

4

### Active assay types

- Confirmatory

## Related records

### Trials (69)

- A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors
- A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.
- A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.
- Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR+/HER2 - Advanced Breast Cancer
- Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma
- Albumin-bound Paclitaxel、Dalpiciclib and AI in ER-Low (1%-10%) HER2-ABC
- An Exploratory Clinical Study of CDK4/6i Dalpiciclib Combined With AI Neoadjuvant Therapy for Stage II-III HR+/HER2- Breast Cancer
- An Exploratory Clinical Study of Dalpiciclib an'd Letrozole Combined With Anlotinib Neoadjuvant Therapy in Stage II-III Postmenopausal HR+/HER2- Early Breast Cancer
- An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody
- Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
- Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer With Brain Metastases
- CDK4/6 Inhibitor Plus Camrelizumab for PD-1 Inhibitor Refractory R/M NPC
- CDK4/6 Inhibitors Intensification for Chemotherapy Omission in Small Size High-risk ER-positive Breast Cancer（Cinnamon）
- Cetuximab Plus Dalpicilib in Patients With HPV Negative, PD-1 Resistant R/M HNSCC
- Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer
- ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
- Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients
- Dalpiciclib Combination With Fulvestrant and Compound Gossyfol Acetate Tablets in Women With CDK4/6 Inhibitor-refractory HR-positive HER-2 Negtive Metastatic Breast Cancer: a Phase 2 Clinical Trial.
- Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment
- Dalpiciclib Combined With Letrozole in HR+/HER2 - Gynecologic Solid Tumors

### In development for (12)

- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3
- [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 3
- [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 1
- [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
- [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1
- [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Phase 1
- [Nasopharyngeal carcinoma](https://trialight.com/data/condition/nasopharyngeal-carcinoma-9ead4a97-f794-5dda-b62e-20f8ca202f89.md) Phase 2
- Neoplasm Phase 2
- Ovarian carcinoma Phase 2
- [Sarcoma](https://trialight.com/data/condition/sarcoma-96102668-50d9-5d69-b154-719396a38dc1.md) Phase 2

---

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