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Zasocitinib

Phase 3

Plaque Psoriasis | Small molecule | Dermatology |Takeda Pharmaceutical Company Limited|Last Updated: Aug 7, 2026

Target and mechanism

Target class-Tinib (Kinase)
ModalitySmall molecule

Also known as Zasocitinib (Dose A)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment716

FDA Designations

No designations recorded

Clinical trial landscape

Zasocitinib · 11 trials · 8 indications

Phase 3 6Phase 2 4Phase 1 1
NCT07752108A Study of Zasocitinib in Adults With Non-pustular Palmoplantar PsoriasisPalmoplantar Psoriasis
NOT YET_RECRUITING40 Analytics
NCT07286058Continuation Study of Zasocitinib in Adults With Psoriatic ArthritisPsoriatic Arthritis
RECRUITING1,182 Analytics
NCT07250802A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque PsoriasisPlaque Psoriasis
RECRUITING110 Analytics
NCT06973291A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque PsoriasisPlaque Psoriasis
COMPLETED606 Analytics
NCT06671496A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic MedicinesPsoriatic Arthritis
RECRUITING600 Analytics
NCT06671483A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic MedicinesPsoriatic Arthritis
RECRUITING1,088 Analytics
PHASE3NOT YET_RECRUITING
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar PsoriasisUnlock trial analytics
PHASE3RECRUITING
Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis
Psoriatic ArthritisUnlock trial analytics
PHASE3RECRUITING
A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis
Plaque PsoriasisUnlock trial analytics
PHASE3COMPLETED
A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis
Plaque PsoriasisUnlock trial analytics
PHASE3RECRUITING
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines
Psoriatic ArthritisUnlock trial analytics
PHASE3RECRUITING
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines
Psoriatic ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Percentage of Participants Achieving Palmoplantar Investigator's Global Assessment (ppIGA) 0 or 1 ("Clear" or "Almost Clear") With at least a 2-point Reduction From Baseline at Week 16
At Week 16

The ppIGA is a 5-point score ranging from 0 to 4, based on the investigator's assessment of the average erythema (redness), induration (thickness), scaling and fissures of all palmoplantar (non-pustular) psoriatic lesions. A lower score indicates lower severity, with 0 being "clear" and 1 being "almost clear."

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From start of study drug administration up to follow-up (up to Week 108)

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. TEAE is defined as any AE emerging or manifesting at or after the initiation of treatment in the LTE study with a trial intervention or medicinal product or any existing AE that worsens in either intensity or frequency following exposure to the trial intervention or medicinal product. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or is an important medical event.

Number of Participants With Adverse Events of Special Interest (AESI)
From start of study drug administration up to follow-up (up to Week 108)

An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.

Number of Participants With Clinically Significant Changes in Vital Sign Values
From start of study drug administration up to follow-up (up to Week 108)

Vital signs will include measurement of body temperature, respiratory rate, sitting blood pressure and pulse rate. Any clinically significant change in vital signs will be determined at the investigator's discretion.

Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
From start of study drug administration up to follow-up (up to Week 108)

Laboratory parameters will include hematology, chemistry and urinalysis. Any clinically significant change in laboratory values will be determined at the investigator's discretion.

Part A: Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a Greater than or Equal to (>=) 2-Point Decrease From Baseline at Week 16
At Week 16

The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA composite score ranges from 0 to 4 and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean greater than (\>) 0, less than (\<) 1.5; Mild (2) = mean \>= 1.5, \<2.5; Moderate (3) = mean \>=2.5, \<3.5; and Severe (4) = mean \>=3.5. The percentage of participants achieving an sPGA of Clear (0) or Almost Clear (1) with a \>= 2-point decrease from baseline at Week 16 will be reported.

Part A: Percentage of Participants Achieving >= 75 Percent (%) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16
At Week 16

The PASI is a measure of the average redness, thickness and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity (less than or equal to \[\<=\] 3 representing mild disease, \>= 3 to 15 representing moderate disease, and \>= 15 indicating severe disease). The PASI-75 is defined as 75% improvement from baseline in PASI score. The percentage of participants achieving \>= 75% improvement from baseline in PASI score at Week 16 will be reported.

Part B: Maximum Observed Plasma Concentration (Cmax) of Zasocitinib
Pre-dose and Post-dose on Day 7

Cmax of zasocitinib in plasma will be assessed.

Part B: Time to Maximum Concentration (Tmax) of Zasocitinib
Pre-dose and Post-dose on Day 7

Tmax of zasocitinib in plasma will be assessed.

Part B: Area Under the Concentration-Time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-Last) of Zasocitinib
Pre-dose and Post-dose on Day 7

AUC0-Last of zasocitinib in plasma will be assessed.

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-100 at Week 16
At Week 16

PASI is a measure of the average erythema, induration/infiltration, and desquamation/scaling of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72 (less than or equal to \[\<=\] 3 representing mild disease, greater than or equal to \[\>=3\] to 15 representing moderate disease, and \>=15 indicating severe disease) with higher PASI scores denoting more severe disease activity. Percentage of participants showing 100 percentage (%) improvement in PASI score relative to baseline PASI score will be reported.

Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo
At Week 16

ACR responses are the numerical measurement of improvement in multiple disease assessment criteria. It is a composite clinical outcome assessment (COA) measure that includes both clinician-reported outcome assessments (ClinROs) and patient-reported outcomes (PROs). An ACR20 response is defined as: greater than or equal to (\>=) 20 percent (%) improvement from baseline in both swollen joint count 66 joints (SJC66) and tender joint count 68 joints (TJC68), and \>=20% improvement from baseline in 3 of the following 5 assessments: Patient's global assessment (PtGA) of psoriatic arthritis (PsA) pain; PtGA of PsA; physician's global assessment of disease activity (PGA) of PsA; participant's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-DI); high-sensitivity C-reactive protein (hsCRP). Percentage of participants achieving ACR20 response at Week 16 for zasocitinib Dose A and B compared to placebo will be reported.

Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interests (AESIs)
From start of study drug administration up to follow-up (up to Week 16)

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency after exposure to the trial intervention. An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.

Percentage of Participants who Achieve 75 Percent (%) Reduction in Hidradenitis Suppurativa Clinical Response (HiSCR75)
At Week 16

HiSCR75 is defined as at least a 75% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess or draining tunnel count relative to baseline.

Percentage of Participants Achieving >= 75% Improvement From Baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24
Baseline, Week 24

The vitiligo area scoring index (VASI) is a validated scoring method used to assess the areas of depigmentation due to vitiligo. The F-VASI includes contributions from the face, with a possible range from 0 to 3.5, with higher scores indicating more severe disease. Negative changes from baseline indicate improvement. This is recorded as either Yes (achieved \>= 75% improvement) or No (did not achieve).

All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
From start of study drug administration up to Week 160 (current study)

TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product. An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.

All Cohorts: Number of Participants With Clinically Significant Changes in Vital Sign Values
From start of study drug administration up to Week 160 (current study)

Vital sign values include body temperature, respiratory rate, sitting blood pressure (systolic and diastolic, resting more than 5 minutes), pulse (beats per minute). Clinical significance of vital signs will be determined at the investigator's discretion.

All Cohorts: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
From start of study drug administration up to Week 160 (current study)

Laboratory parameters include hematology, clinical chemistry and urinalysis. Clinical significance of laboratory values will be determined at the investigator's discretion.

Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Values
At Day 1 and Week 156 (current study)

ECGs will be performed with the participant in the supine or semi-supine position and after resting comfortably for at least 5 minutes. Clinical significance of 12-lead ECG values will be determined at the investigator's discretion.

Part 1: Cmax: Maximum Observed Plasma Concentration for LNG and EE When Administered Alone and With Zasocitinib
Up to 144 hours
Part 1: AUCinf: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for LNG and EE When Administered Alone and With Zasocitinib
Up to 144 hours
Part 1: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for LNG and EE When Administered Alone and With Zasocitinib
Up to 144 hours
Part 2: Cmax for Metformin When Administered Alone and With Zasocitinib
Up to 48 hours
Part 2: AUCinf for Metformin When Administered Alone and With Zasocitinib
Up to 48 hours
Part 2: AUClast for Metformin When Administered Alone and With Zasocitinib
Up to 48 hours
Part 3: Cmax for Digoxin When Administered Alone and With Zasocitinib
Up to 144 hours
Part 3: AUCinf for Digoxin When Administered Alone and With Zasocitinib
Up to 144 hours
Part 3: AUClast for Digoxin When Administered Alone and With Zasocitinib
Up to 144 hours
Part 4: Cmax for Zasocitinib When Administered Alone and With Esomeprazole
Up to 120 hours
Part 4: AUCinf for Zasocitinib When Administered Alone and With Esomeprazole
Up to 120 hours
Part 4: AUClast for Zasocitinib When Administered Alone and With Esomeprazole
Up to 120 hours

Secondary Endpoints

Part 1: Percentage of Participants Achieving >=75%, >=90% and 100% Improvement From Baseline in Palmoplantar Psoriasis Area and Severity Index (PPASI-75, PPASI-90 and PPASI-100) at Week 16
At Week 16
Part 1: Percentage of Participants Achieving Static Physician's Global Assessment (sPGA) 0 or 1 ("Clear" or "Almost Clear") With at Least a 2-point Reduction From Baseline at Week 16
At Week 16
Part 1: Percentage of Participants Achieving an sPGA 0 at Week 16
At Week 16
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Zasocitinib 30 mgEXPERIMENTALParticipants will receive zasocitinib 30 milligrams (mg), orally, once daily (QD) from Day 1 through Week 16. Participants who complete 16 weeks treatment will be eligible to continue into Part 2 and those who do not enter Part 2, will enter a 4-week safety follow-up period.
Part 2: Zasocitinib 30 mgEXPERIMENTALEligible participants who continue from Part 1 to Part 2 (if determined by principal investigator \[PI\]) will receive zasocitinib 30 mg, orally, QD from Week 16 through Week 52, followed by a 4-week safety follow-up period.
Optional Long-Term Extension (LTE): ZasocitinibEXPERIMENTALParticipants who are receiving zasocitinib and complete Week 52, will have the option to continue to receive uninterrupted zasocitinib therapy for up to an additional 52 weeks or until it becomes commercially available, whichever comes first.
Zasocitinib Dose A or Dose BEXPERIMENTALParticipants assigned to zasocitinib in the either parent studies (TAK-279-PsA-3001 \[NCT06671483\] or TAK-279-PsA-3002 \[NCT06671496\]) will continue to receive zasocitinib Dose A or Dose B at the same dose, oral tablets, QD for up to Week 104.
Re-randomized Participants - Zasocitinib Dose A or Dose BEXPERIMENTALParticipants assigned to active comparator in the parent study (TAK-279-PsA-3001 \[NCT06671483\]) will be re-randomized to blinded treatment with zasocitinib Dose A or Dose B, oral tablets, QD for up to Week 104.
Part A (Cohort 1): Zasocitinib (Dose A)EXPERIMENTALParticipants (Adolescent) aged 12 to less than (\<)18 years will receive zasocitinib Dose A once daily (QD), orally, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib, from Week 16 to Week 208 during the open-label period.
Part A (Cohort 2): Zasocitinib (Multiple Doses)EXPERIMENTALParticipants (Children) aged 4 to \<12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 16 during the double-blind placebo-controlled period followed by zasocitinib from Week 16 to Week 208 during the open-label period.
Part A (Cohort 1 and Cohort 2): PlaceboPLACEBO_COMPARATORParticipants in Cohort 1 (Adolescent aged 12 to \<18 years) and Cohort 2 (Children aged 4 to \<12 years) will receive zasocitinib matching placebo QD from Week 1 to Week 16 during the double-blind placebo-controlled period.
Part B: Zasocitinib (Multiple Doses)EXPERIMENTALParticipants (Children) aged 4 to \<12 years will receive zasocitinib, orally, doses based on weight, from Week 1 to Week 208 during the open-label period.
Zasocitinib or PlaceboEXPERIMENTALParticipants will receive zasocitinib or matching placebo tablet, orally, once daily (QD) up to Week 16.
Deucravacitinib or PlaceboACTIVE_COMPARATORParticipants will receive deucravacitinib 6 mg or matching placebo capsule, orally, QD up to Week 16.
Zasocitinib Dose AEXPERIMENTALParticipants will receive zasocitinib Dose A, tablets, orally, once daily (QD) for up to Week 52.
Zasocitinib Dose BEXPERIMENTALParticipants will receive zasocitinib Dose B, tablets, orally, QD for up to Week 52.
Placebo + ZasoctinibEXPERIMENTALParticipants will receive placebo, orally, QD for up to Week 16, followed by zasoctinib Dose A or Dose B, orally, QD, from Week 16 up to Week 52.
Active Comparator Dose CACTIVE_COMPARATORParticipants will receive active comparator Dose C, capsules, orally, twice daily (BID) for up to Week 52.
Zasocitinib DoseEXPERIMENTALParticipants will receive zasocitinib dose orally, once daily (QD) for 12 week treatment period (Week 0 to 12).
Double-blinded: Zasocitinib (Dose A)EXPERIMENTALParticipants will receive zasocitinib (Dose A) from Day 1 to Week 16 during the double-blind period.
Double-blinded: PlaceboPLACEBO_COMPARATORParticipants will receive placebo from Day 1 to Week 16 during the double-blind period.
Open-label: Zasocitinib (Dose A)EXPERIMENTALParticipants will receive zasocitinib (Dose A) from Week 16 to Week 52 during the open label period.
Zasocitinib Low DoseEXPERIMENTALParticipants will receive Zasocitinib capsules, low dose, orally, up to Week 52.
Zasocitinib Medium DoseEXPERIMENTALParticipants will receive Zasocitinib capsules, medium dose, orally, up to Week 52.
Zasocitinib High DoseEXPERIMENTALParticipants will receive Zasocitinib capsules, high dose, orally, up to Week 52.
Placebo Group 1/ Zasocitinib Medium DoseEXPERIMENTALParticipants will receive Placebo Group 1 orally, up to Week 24 followed by Zasocitinib capsules, medium dose, orally, up to Week 52.
Placebo Group 2/ Zasocitinib High DoseEXPERIMENTALParticipants will receive Placebo Group 2, orally, up to Week 24 followed by Zasocitinib capsules, high dose, orally, up to Week 52.
Cohort 1: ZasocitinibEXPERIMENTALParticipants with CD who completed Week 52 of the parent study, TAK-279-CD-2001 (NCT06233461) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks.
Cohort 2: ZasocitinibEXPERIMENTALParticipants with UC who completed Week 52 of the parent study, TAK-279-UC-2001 (NCT06254950) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks.
Cohort 3: ZasocitinibEXPERIMENTALParticipants with CD who completed Week 12 of the parent study, TAK-279-CD-2003 (NCT07403968) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks.
Part 1: COC (LNG and EE) + ZasocitinibEXPERIMENTAL -
Part 2: Metformin + ZasocitinibEXPERIMENTAL -
Part 3: Digoxin + ZasocitinibEXPERIMENTAL -
Part 4: Zasocitinib + EsomeprazoleEXPERIMENTAL -

Interventions

NameTypeDescription
ZasocitinibDRUGZasocitinib oral tablet.
PlaceboDRUGZasocitinib matching placebo.
DeucravacitinibDRUGDeucravacitinib capsules.
Placebo to match zasocitinibDRUGZasocitinib matching placebo tablets.
Placebo to match deucravacitinibDRUGDeucravacitinib matching placebo capsules.
Active ComparatorDRUGActive comparator capsule.
Zasocitinib (Dose A)DRUGZasocitinib.
COCDRUGCOC tablets (containing LNG and EE) specified doses on specified days.
MetforminDRUGMetformin tablets specified doses on specified days.
DigoxinDRUGDigoxin tablets specified doses on specified days.
EsomeprazoleDRUGEsomeprazole capsules specified doses on specified days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion criteria: Participant Willingness: 1. The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator. 2. The participant has provided informed consent and any require...

Countries:United StatesAustraliaChinaCzechiaEstoniaGermanyIsraelJapanPolandPuerto RicoItalySpainBulgariaCanadaFranceLatviaArgentinaBrazilUnited KingdomBelgiumChileCroatiaHungaryMexicoNew ZealandPortugalSouth KoreaTaiwanNetherlandsSlovakia
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Recent Changes (Last 90 Days)

LOWAug 7, 2026NCT07752108NEW_TRIAL: changed
LOWAug 7, 2026NCT07752108NEW_TRIAL: changed
LOWAug 3, 2026NCT07286058lastUpdatePostDate: changed
LOWAug 3, 2026NCT07286058lastUpdatePostDate: changed
LOWJul 29, 2026NCT06671483lastUpdatePostDate: changed
LOWJul 29, 2026NCT06671496lastUpdatePostDate: changed
LOWJul 29, 2026NCT06671483lastUpdatePostDate: changed
LOWJul 29, 2026NCT06671496lastUpdatePostDate: changed
LOWJul 21, 2026NCT07250802lastUpdatePostDate: changed
LOWJul 17, 2026NCT07108283lastUpdatePostDate: changed
LOWJul 17, 2026NCT07108283lastUpdatePostDate: changed
LOWJul 2, 2026NCT07403968startDate: changed
LOWJul 2, 2026NCT07403968startDate: changed
LOWJul 2, 2026NCT07403968startDate: changed
LOWJul 2, 2026NCT07403968startDate: changed
LOWJun 29, 2026NCT06671483lastUpdatePostDate: changed
LOWJun 29, 2026NCT06671496lastUpdatePostDate: changed
LOWJun 29, 2026NCT06671483lastUpdatePostDate: changed
LOWJun 29, 2026NCT06671496lastUpdatePostDate: changed
LOWJun 18, 2026NCT07286058lastUpdatePostDate: changed

Frequently asked questions about Zasocitinib

What is Zasocitinib used for?

Zasocitinib is an investigational small molecule being studied for hidradenitis suppurativa, nonsegmental vitiligo, Crohn's disease, plaque psoriasis, psoriatic arthritis, and palmoplantar psoriasis. It is a kinase inhibitor in the -tinib class. The drug is not approved and remains in clinical development.

Who makes Zasocitinib?

Zasocitinib is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is also known as Zasocitinib (Dose A) and is an investigational small molecule kinase inhibitor.

What phase is Zasocitinib in?

Zasocitinib is in Phase 2 clinical development for nonsegmental vitiligo, with additional Phase 3 trials for psoriatic arthritis and plaque psoriasis. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is Zasocitinib in?

Zasocitinib has multiple trials, including NCT06671496 for psoriatic arthritis, NCT06973291 comparing it with deucravacitinib in plaque psoriasis, NCT07108283 for nonsegmental vitiligo, and NCT07250802 for plaque psoriasis in children and teenagers. These trials are recruiting or completed.

Is Zasocitinib the same as Zasocitinib (Dose A)?

Yes, Zasocitinib is also known as Zasocitinib (Dose A). It is a small molecule kinase inhibitor being developed by Takeda for multiple inflammatory and autoimmune conditions.

What does Zasocitinib target?

Zasocitinib targets kinases, as it belongs to the -tinib class of kinase inhibitors. It is being studied for conditions such as plaque psoriasis, psoriatic arthritis, and nonsegmental vitiligo, though the specific molecular target is not detailed.