Opzelura

(golidocitinib)

Phase 3Small molecule

It is a topical cream used to treat atopic dermatitis (eczema) by reducing inflammation and itching on the skin.[1] Opzelura is currently being investigated across 19 indications[3], with its most advanced program in Phase 3.[1]

Opzelura is one of 326 small molecule programs targeting Type II Hypersensitivity Reaction Disease. It is currently in Phase 3.

Indications

Total Trials

Active Trials

325

Competitors

Pipeline

Status by Indication[3][1]

Indication

Type II Hypersensitivity Reaction DiseaseActive, not recruiting

Mycosis Fungoides/sezary SyndromeNot yet recruiting

Interstitial Lung DiseasesNot yet recruiting

Nodal T-Follicular Helper Cell LymphomaNot yet recruiting

Cutaneous T-Cell Lymphoma (CTCL)Recruiting

First-Line TreatmentRecruiting

Non-Small Cell Lung CancerNot yet recruiting

Lung CancerNot yet recruiting

LymphomaNot yet recruiting

Severe Aplastic AnemiaNot yet recruiting

Type II Hypersensitivity Reaction DiseasePreclinical

Active, not recruiting

Mycosis Fungoides/sezary SyndromePhase 2

Not yet recruiting

Interstitial Lung DiseasesPhase 2

Not yet recruiting

Nodal T-Follicular Helper Cell LymphomaPhase 2

Not yet recruiting

Cutaneous T-Cell Lymphoma (CTCL)Preclinical

Recruiting

First-Line TreatmentPhase 1

Recruiting

Non-Small Cell Lung CancerPhase 2

Not yet recruiting

Lung CancerPhase 2

Not yet recruiting

LymphomaPhase 3

Not yet recruiting

Severe Aplastic AnemiaPhase 2

Not yet recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Opzelura

DDizal Pharmaceuticals

Phase 3

1 2

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

1 3

Furmonertinib

AAllist Pharmaceuticals, Inc.

Phase 3

6 4

Neladalkib (NVL-655)

NNuvalent Inc.

Phase 3

1 5

Remeron

OOrganon and Co

Preclinical

1 6

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—7

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—8

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

1 10

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1/2Not yet recruiting

Lymphoma

NCT07209163

Q2 2027

Phase 2/3Recruiting

Clinical Trial

NCT07339345

Q3 2027

Phase 1/2Not yet recruiting

Severe Aplastic Anemia

NCT07297550

Phase 2Not yet recruiting

Interstitial Lung Diseases

NCT07737249

Q4 2027

Phase 2Not yet recruiting

Non-Small Cell Lung Cancer

NCT06198907

Phase 2Not yet recruiting

Lymphoma

NCT06701344

Clinical

Trials by Indication[1]

Lymphoma7 trials

Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma

Not yet recruiting·FFudan University·Phase 3·NCT07300514·136 enrolled

Assessing An Oral JAK1 Inhibitor, Golidocitinib, in Patients Who Have Newly Diagnosed Peripheral T-Cell Lymphoma (JACKPOT23)

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07032532·35 enrolled

EZH2 Inhibitor Zeprumetostat in Combination Therapy for Patients With Relapsed or Refractory Mature T-cell and NK-cell Lymphomas

Not yet recruiting·SSun Yat-sen University·Phase 1/2·NCT07339527·60 enrolled

Show 4 more trials

Combination Therapy With Tazemetostat in Relapsed and Refractory Peripheral T-cell Lymphoma

Not yet recruiting·RRuijin Hospital·Phase 1/2·NCT07209163·48 enrolled

Go-CHOP in de Novo Intestinal T-cell Lymphoma Patients

Not yet recruiting·RRuijin Hospital·Phase 2·NCT06701344·7 enrolled

Golidocitinib Combined With Mitoxantrone Hydrochloride Liposome or Chidamide in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma

Recruiting·SSun Yat-sen University·Phase 1/2·NCT07093710·101 enrolled

A Phase II, Single-center, Single-arm Study Evaluating the Safety and Efficacy of Golidocitinib in the Management of Newly Diagnosed Peripheral T Cell Lymphoma Patients (GOLDEN Study) and Correlative Study

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06630091·30 enrolled

PTCL2 trials

A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19)

Recruiting·DDizal Pharmaceuticals·Phase 3·NCT07234162·218 enrolled

Golidocitinib Combined With GemOx in RR PTCL

Not yet recruiting·RRuijin Hospital·Phase 2·NCT07279584·31 enrolled

Clinical Trial1 trial

Prospective Single-Arm Clinical Trial of GO Regimen for HLH.

Recruiting·—·Phase 2/3·NCT07339345·28 enrolled

Safety and Efficacy1 trial

A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Selinexor for the Treatment of R/R NKTCL

Recruiting·FFudan University·Phase 1/2·NCT06966154·68 enrolled

Non-Small Cell Lung Cancer1 trial

Golidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC)

Not yet recruiting·—·Phase 2·NCT06198907·69 enrolled

15 more indications

Adult1 trial

An Exploratory Study of Golidocitinib in Adult Patients With ITP

Not yet recruiting·PPeking University People's Hospital·Phase 1/2·NCT07196163·138 enrolled

EBV1 trial

Golidocitinib Combined With Selinexor for CAEBVD

Recruiting·—·Phase 2/3·NCT07369739·28 enrolled

Severe Aplastic Anemia1 trial

Safety and Efficacy of the JAK1 Inhibitor Combined With Intensive Immunosuppressive Therapy in Severe Aplastic Anemia

Not yet recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 1/2·NCT07297550·42 enrolled

Lung Cancer1 trial

Golidocitinib for Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer

Not yet recruiting·TThe First Affiliated Hospital of Guangzhou Medical University·Phase 2·NCT07303881·16 enrolled

First-line Treatment1 trial

A Study on the Efficacy and Safety of Golidocitinib Combined With Tislelizumab and Chemotherapy as First-line Treatment for Advanced NSCLC

Recruiting·PPeking University Cancer Hospital & Institute·Phase 1·NCT06969612·21 enrolled

Frontline1 trial

Go-CHOP as the Frontline Therapy for PTCL

Recruiting·HHenan Cancer Hospital·Phase 2·NCT05963347·45 enrolled

Benmelstobart1 trial

Phase II Study of Golidocitinib and Benmelstobart in Patients with R/R ENKTL (JACKPOT50)

Recruiting·SSun Yat-sen University·Phase 2·NCT06733051·47 enrolled

PD-1antibody1 trial

PD-1 Antibody-based Therapy With Concurrent RT for Early-stage NKTCL

Recruiting·RRuijin Hospital·Phase 2·NCT07380984·47 enrolled

Monotherapy1 trial

Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)

Completed·DDizal Pharmaceuticals·Phase 1/2·NCT04105010·171 enrolled

Maintenance Therapy1 trial

Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR/PR) After First-Line Chemotherapy

Recruiting·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 3·NCT07414758·68 enrolled

Non-segmental Vitiligo1 trial

Efficacy and Safety of Ruxolitinib Phosphate Cream Combined With Corticosteroids in Patients With Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study

Recruiting·SShanShan Li··NCT07673640·300 enrolled

Cutaneous T-cell Lymphoma (CTCL)1 trial

A Prospective Single-Center Phase I/II Clinical Study of Golidocitinib Combined With Chidamide in Patients With Systemically-Treated Cutaneous T-Cell Lymphoma

Recruiting·PPeking Union Medical College Hospital·Preclinical·NCT07754890·65 enrolled

Nodal T-follicular Helper Cell Lymphoma1 trial

A Phase II, Prospective, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Golidocitinib Combined With an Anthracycline-Based Regimen as First-Line Treatment for Patients With Nodal T-follicular Helper (TFH) Cell Lymphoma

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07753642·47 enrolled

Interstitial Lung Diseases1 trial

A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Golidocitinib in Rapidly Progressive Interstitial Lung Disease

Not yet recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07737249·60 enrolled

Mycosis Fungoides/Sezary Syndrome1 trial

A Pilot Study of Golidocitinib, a JAK1 Inhibitor, in Patients With Mycosis Fungoides/Sézary Syndrome and T-Cell Large Granular Lymphocytic Leukemia (GEMSTONE)

Not yet recruiting·WWashington University School of Medicine·Phase 2·NCT07682792·24 enrolled

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for golidocitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — golidocitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for golidocitinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Dizal Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Tyrosine-Protein Kinase JAK1 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: DDizal Pharmaceuticals

Opzelura

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Lymphoma7 trials

PTCL2 trials

Clinical Trial1 trial

Safety and Efficacy1 trial

Non-Small Cell Lung Cancer1 trial

Adult1 trial

EBV1 trial

Severe Aplastic Anemia1 trial

Lung Cancer1 trial

First-line Treatment1 trial

Frontline1 trial

Benmelstobart1 trial

PD-1antibody1 trial

Monotherapy1 trial

Maintenance Therapy1 trial

Non-segmental Vitiligo1 trial

Cutaneous T-cell Lymphoma (CTCL)1 trial

Nodal T-follicular Helper Cell Lymphoma1 trial

Interstitial Lung Diseases1 trial

Mycosis Fungoides/Sezary Syndrome1 trial

References

Drug Info

Quick Facts

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