> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/ritlecitinib-4c942dd0-fc10-47f2-85c8-213af4721107
> Record changed: 2026-10-13

# Ritlecitinib

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

First approval year

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

## Development status

**First approval year**

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

**Drug name**

Ritlecitinib

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

**Molecular weight**

285.35

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

**Structure (SMILES)**

C=CC(=O)N1C\[C@H\](Nc2ncnc3\[nH\]ccc23)CC\[C@@H\]1C

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

### Other names (13)

- 2 propen 1 one 1 2s 5r 2 methyl 5 7h pyrrolo 2 3 d pyrimidin 4 ylamino 1 piperidinyl
- 2-PROPEN-1-ONE, 1-((2S,5R)-2-METHYL-5-(7H-PYRROLO(2,3-D)PYRIMIDIN-4-YLAMINO)-1-PIPERIDINYL)-
- pf 06651600
- Pf-06651600
- PF-06651600
- ritlecitinib
- Ritlecitinib
- ritlecitinib \[INN\]
- Ritlecitinib \[MI\]
- Ritlecitinib \[WHO-DD\]
- ritlecitinib inn
- ritlecitinib mi
- ritlecitinib who dd

## Identifiers

**ATC classification codes**

- L04AF08

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

**CAS registry numbers**

- 1792180-81-4

**ChEMBL ID**

CHEMBL4085457

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

**InChIKey**

CBRJPFGIXUFMTM-WDEREUQCSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4085457)

**PubChem compound IDs**

- 118115473

**RxNorm IDs (RxCUI)**

- 2641595

**FDA ingredient codes (UNII)**

- 2OYE00PC25

## Regulatory information

### United States

**Applicant**

PFIZER

**Approval date**

23 Jun 2023

**Application number**

NDA215830

### European Union

**Status**

Authorised

**Status date**

15 Sept 2023

**Authorisation date**

15 Sept 2023

**Approved indications**

Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older.

**Product number**

EMEA/H/C/006025

**Authorisation holder**

Pfizer Europe MA EEIG

**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

- Alopecia Areata

European medicines record

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

### Other regulatory facts

**Patents**

0

**Designations**

2

**First in class**

No

**Fast track**

No

**Breakthrough designation**

Yes

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

**Boxed warning**

Yes

## Pharmacology

### Drug classification

**Pharmacology name**

ritlecitinib

**Type**

Synthetic organic

**Drug name stem**

\-tinib

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (8)

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
Janus kinase 1

**Gene symbol**  
JAK1

**Protein identifier**  
P23458

**Median affinity**

5.79

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

**Action type**  
Inhibitor

**Target**  
Janus kinase 3

**Gene symbol**  
JAK3

**Protein identifier**  
P52333

**Median affinity**

9.52

**Affinity units**  
pIC50

**Primary target**  
Yes
- **Mechanism**  
TEC family kinase inhibitor

**Action type**  
Inhibitor

**Target**  
TEC family kinase

**Protein identifier**  
P42680
- **Mechanism**  
TEC family kinase inhibitor

**Action type**  
Inhibitor

**Target**  
TEC family kinase

**Protein identifier**  
P42681
- **Mechanism**  
TEC family kinase inhibitor

**Action type**  
Inhibitor

**Target**  
TEC family kinase

**Protein identifier**  
P51813
- **Mechanism**  
TEC family kinase inhibitor

**Action type**  
Inhibitor

**Target**  
TEC family kinase

**Protein identifier**  
Q06187
- **Mechanism**  
TEC family kinase inhibitor

**Action type**  
Inhibitor

**Target**  
TEC family kinase

**Protein identifier**  
Q08881
- **Mechanism**  
Tyrosine-protein kinase JAK3 inhibitor

**Action type**  
Inhibitor

**Target**  
Tyrosine-protein kinase JAK3

**Protein identifier**  
P52333

### Open Targets mechanisms (2)

- **Mechanism**  
TEC family kinase inhibitor

**Action type**  
Inhibitor

**Target**  
TEC family kinase
- **Mechanism**  
Tyrosine-protein kinase JAK3 inhibitor

**Action type**  
Inhibitor

**Target**  
Tyrosine-protein kinase JAK3

### Investigated indications (13)

- **Condition**  
Crohn Disease

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000384

**Subject identifier**  
D003424
- **Condition**  
Arthritis, Rheumatoid

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000685

**Subject identifier**  
D001172
- **Condition**  
Colitis, Ulcerative

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000729

**Subject identifier**  
D003093
- **Condition**  
Celiac Disease

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0001060

**Subject identifier**  
D002446
- **Condition**  
Liver Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001421

**Subject identifier**  
D008107
- **Condition**  
Kidney Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003086

**Subject identifier**  
D007674
- **Condition**  
Alopecia Areata

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0004192

**Subject identifier**  
D000506
- **Condition**  
Vitiligo

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0004208

**Subject identifier**  
D014820
- **Condition**  
Keloid

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0004212

**Subject identifier**  
D007627
- **Condition**  
Sezary Syndrome

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1000785

**Subject identifier**  
D012751
- **Condition**  
Mycosis Fungoides

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1001051

**Subject identifier**  
D009182
- **Condition**  
Alopecia

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1002028

**Subject identifier**  
D000505
- **Condition**  
Diabetes Mellitus, Type 1

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0005147

**Subject identifier**  
D003922

### Open Targets indications (24)

- **Condition identifier**  
EFO\_0000384

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000685

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000729

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001060

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

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003086

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0004192
- **Condition identifier**  
EFO\_0004208

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0004212

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1000710

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1002028

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0000607

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004907
- **Condition identifier**  
MONDO\_0004907

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004979

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005011

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005101

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005147

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005340

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005348

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0006559

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0008383

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0008661

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0044212

**Highest recorded phase**  
2

### Open Targets warnings (4)

- **Warning**  
Black Box Warning

**Effect**  
carcinogenicity

**Country**  
United States
- **Warning**  
Black Box Warning

**Effect**  
cardiotoxicity

**Country**  
United States
- **Warning**  
Black Box Warning

**Effect**  
infectious disease

**Country**  
United States
- **Warning**  
Black Box Warning

**Effect**  
vascular toxicity

**Country**  
United States

### Trial references (20)

- NCT02958865  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02958865)
- NCT02969044  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02969044)
- NCT04413617  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04413617)
- NCT02974868  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02974868)
- NCT03732807  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03732807)
- NCT04006457  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04006457)
- NCT04517864  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04517864)
- NCT05650333  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05650333)
- NCT03395184  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03395184)
- NCT03715829  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03715829)
- NCT05583526  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05583526)
- NCT06072183  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06072183)
- NCT06163326  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06163326)
- NCT04016077  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04016077)
- NCT04037865  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04037865)
- NCT05549934  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05549934)
- NCT05636293  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05636293)
- NCT05743244  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05743244)
- NCT05879458  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05879458)
- NCT06373458  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06373458)

## Dosing

**Dose**

50 mg

**Route**

Oral

**How often**

Once daily

### Conditions of use (2)

- Do not crush, split, or chew capsules
- Swallow capsules whole

## Chemical properties

**Hydrogen bond acceptors**

4

**Hydrogen bond donors**

2

**Polar surface area**

73.91

**Calculated partition coefficient (ALogP)**

1.94

**Calculated partition coefficient (XLogP)**

2.1

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

3

**Heavy atoms**

21

**Molecular formula**

C15H19N5O

**Monoisotopic mass**

285.15896025

**Natural product**

No

## Evidence counts

**Recorded assays**

229

**Active assays**

65

### Active assay types (2)

- Confirmatory
- Other

## Pharmacologic actions

- Janus Kinase Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000075242.html)
- Tyrosine Kinase Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000092004.html)

## Biological measurements

### Observed measurements

#### Oral bioavailability

**Median**

64

**Mean**

75.2

**Minimum**

56

**Maximum**

109

**Unit**

%

**Assays**

5

**Standard deviation**

21.8335

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- F

## Related records

### Trials (53)

- [A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2](https://trialight.com/data/trial/a-104-week-study-of-ritlecitinib-oral-capsules-in-adults-ff919ca0-6ace-45c1-b983-750c0c3cc811.md)
- A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.
- A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents With Nonsegmental Vitiligo (Active and Stable) Tranquillo
- A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
- A DRUG-DRUG INTERACTION STUDY BETWEEN PF-06650833 AND PF-06651600 FOLLOWING MULTIPLE DOSES IN HEALTHY PARTICIPANTS
- A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
- A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
- A Renal Impairment Study for PF-06651600
- A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults
- A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata
- [A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata](https://trialight.com/data/trial/a-study-of-2-doses-of-ritlecitinib-in-people-12-years-of-age-d5004d40-93b5-4a61-97a0-68091c6fb464.md)
- A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants
- A Study to Assess Two Forms of The Study Medicine (Ritlecitinib) in Healthy Adult Participants
- A STUDY TO ESTIMATE THE EFFECT OF PF-06651600 ON THE PHARMACOKINETICS (PK) OF ORAL CONTRACEPTIVE (OC)
- A STUDY TO EVALUATE THE EFFECT OF PF-06651600 ON PHARMACOKINETICS OF SINGLE DOSE SUMATRIPTAN IN HEALTHY PARTICIPANTS.
- A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of PF-06651600 in Subjects With Hepatic Impairment and Healthy Volunteers
- A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food
- A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
- A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
- A Study to Learn About the Medicine Called Ritlecitinib in Adults With Severe Alopecia Areata in Real-world Settings

### In development for (15)

- [Alopecia areata](https://trialight.com/data/condition/alopecia-areata-8709d8ab-db3b-57e6-88fa-7d7ae93d4561.md) Phase 3
- [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Phase 2
- [Celiac disease](https://trialight.com/data/condition/celiac-disease-4cbc090d-ae58-587f-a833-9f3b17bc0ea0.md) Phase 2
- [Crohn disease](https://trialight.com/data/condition/crohn-disease-f7aa2cd8-9680-56b5-858c-2b75f88fb0d0.md) Phase 2
- [Hidradenitis suppurativa](https://trialight.com/data/condition/hidradenitis-suppurativa-c1030a8d-4971-5d31-b030-aa19715eb7a2.md) Phase 2
- Keloid 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
- [Mycosis fungoides](https://trialight.com/data/condition/mycosis-fungoides-dfed1f75-762a-528c-b446-218ae612379e.md) Phase 2
- Pseudopelade of Brocq Phase 2
- [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) Phase 2
- Sezary syndrome Phase 2
- Type 1 diabetes mellitus Phase 2
- [Ulcerative colitis](https://trialight.com/data/condition/ulcerative-colitis-afbc4579-f001-5a8a-b904-28f09f344ab5.md) Phase 2
- Vitiligo Phase 3

### Other linked conditions (1)

- [Alopecia](https://trialight.com/data/condition/alopecia-bb72324d-7d2e-5ac9-962f-2cdc0cf3ca73.md)

### Targets (6)

- [BMX](https://trialight.com/data/target/bmx-49d2436f-1bdb-58dd-9637-05eafb2c144e.md) TEC family kinase inhibitor
- [BTK](https://trialight.com/data/target/btk-0715d96c-6e26-5c6e-a6e0-2a745512051d.md) TEC family kinase inhibitor
- [ITK](https://trialight.com/data/target/itk-e8d7f08e-49be-5ca0-9157-b8d3d1890b60.md) TEC family kinase inhibitor
- [JAK3](https://trialight.com/data/target/jak3-be0452ac-5f65-592e-9b95-3663e6d8709b.md) Tyrosine-protein kinase JAK3 inhibitor
- [TEC](https://trialight.com/data/target/tec-a3f3fd4a-23d3-572d-8027-0fe2a19843ce.md) TEC family kinase inhibitor
- [TXK](https://trialight.com/data/target/txk-88098da1-85ce-56df-993b-813e535600e8.md) TEC family kinase inhibitor

---

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