Delving into the Latest Updates on Deucravacitinib with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Deucravacitinib (USAN), 德卡伐替尼, BMS-986165

+ [5]

Target

TYK2

Action

inhibitors

Mechanism

TYK2 inhibitors(Tyrosine-protein kinase 2 inhibitors)

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal DiseasesInfectious Diseases+ [3]

Active Indication

Erythrodermic psoriasisPsoriasis vulgarisPustular psoriasis+ [9]

Inactive Indication

Alopecia AreataColitis, UlcerativeCrohn Disease+ [11]

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Bristol-Myers Squibb Pharma EEIG

Bristol Myers Squibb Co.Bristol-Myers Squibb Australia Pty Ltd.

+ [2]

Inactive Organization

Bristol-Myers Squibb (China) Investment Co. Ltd.

Dartmouth-Hitchcock Medical Center

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (09 Sep 2022),

Plaque psoriasis

RegulationSpecial Review Project (China), Orphan Drug (Japan)

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Structure/Sequence

Molecular FormulaC20H22N8O3

InChIKeyBZZKEPGENYLQSC-FIBGUPNXSA-N

CAS Registry1609392-27-9

The purpose of this research study is to determine the effectiveness of adding deucravacitinib to the participant's current Psoriatic Arthritis (PsA) treatment to see if it improves their symptoms and quality of life.
This study is exploring a new treatment approach that may help improve control of psoriatic disease by targeting different parts of the disease process. By combining therapies that work together, the goal is to offer better symptom relief with fewer or more manageable side effects than some current treatments.

Start Date15 Dec 2025

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

NCT06979453

/ RecruitingPhase 3

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis

Start Date03 Dec 2025

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT07012057

/ WithdrawnPhase 2IIT

A Phase II Open-Label Study of Deucravacitinib for Refractory Adults With Dermatomyositis/ Juvenile Dermatomyositis

Background:
Dermatomyositis (DM) and juvenile dermatomyositis (JDM) are diseases that weaken the immune system. DM and JDM can affect the muscles, skin, joints, and lungs and cause skin rashes and muscle inflammation. Symptoms include weakness, pain, fatigue, and rash. Not everyone responds to current treatments. The FDA has approved a drug called deucravacitinib to treat people with plaque psoriasis. Researchers want to find out if this drug can help people with DM or JDM, too.
Objective:
To test deucravacitinib in people with DM or JDM.
Eligibility:
People aged 18 years and older with DM or JDM.
Design:
Participants will have 9 clinic visits over 28 weeks.
Participants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will complete a short questionnaire about their daily life, pain level, and ability to walk, eat, and do other activities.
Deucravacitinib is a pill taken by mouth twice per day at home. Participants will come to the clinic once every 4 weeks for 24 weeks while they are taking the drug. They will have a final visit 4 weeks after their last dose of the study drug. Blood and urine tests will be repeated during these visits. Each visit may take up to 6 hours.
If the drug is helping them, participants may extend their treatment beyond the first 24 weeks. Then they will visit the clinic every 3 months.

Start Date21 Nov 2025

Sponsor / Collaborator-

100 Clinical Results associated with Deucravacitinib

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100 Translational Medicine associated with Deucravacitinib

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100 Patents (Medical) associated with Deucravacitinib

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293

Literatures (Medical) associated with Deucravacitinib

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

A cost-effectiveness analysis of deucravacitinib vs. apremilast in moderate-to-severe psoriasis patients in Japan

Article

Author: van de Wetering, Gijs ; Tada, Yayoi ; Roberts, David ; Hikichi, Yusuke ; Kim, Hyunchung ; Smith, Martina

OBJECTIVE:

This study aimed to evaluate the cost-effectiveness of deucravacitinib vs. apremilast as a treatment for moderate-to-severe psoriasis patients from a Japan healthcare system perspective.

METHODS:

A Markov sequence model was developed, consisting of an induction phase, maintenance phase, best supportive care and death. Clinical inputs were predominantly derived from the POETYK-PSO-1 and -2 trials (NCT03624127 and NCT03611751), and cost and resource use inputs were derived from several Japanese sources, including Ministry of Health and Welfare (MHLW) data and the outputs of a Delphi survey with Japanese clinical experts. Health-related quality of life inputs were based on the change in utility associated with different levels of Psoriasis Area and Severity Index (PASI) response. Deterministic and probabilistic sensitivity analyses were conducted to account for uncertainty around the base case and several scenario analyses were performed to explore structural uncertainty related to assumptions and methodological choices.

RESULTS:

In the base case, treatment with deucravacitinib results in a discounted QALY gain of 0.30 and discounted incremental costs of ¥459,771 compared to apremilast, resulting in an ICUR of ¥1,546,713 per QALY which is below the Japanese willingness to pay threshold of ¥5,000,000 per QALY. Deterministic and probabilistic sensitivity analyses support the results of the base case. The latter shows that deucravacitinib has a 97.8% probability of being cost-effective compared to apremilast at the ¥5,000,000 per QALY threshold. The outcomes of all scenarios confirmed the cost-effectiveness of deucravacitinib compared to apremilast, with deucravacitinib being dominant in one scenario.

CONCLUSIONS:

Deucravacitinib is cost-effective compared to apremilast in patients with moderate-to-severe plaque psoriasis in Japan, primarily driven by improvements in health-related quality of life associated with a more favorable PASI response. This conclusion is supported by extensive sensitivity and scenario analyses.

31 Dec 2025·ANNALS OF MEDICINE

Cardiovascular safety of Janus kinase inhibitors in inflammatory bowel disease: a systematic review and network meta-analysis

Review

Author: Wang, Bangmao ; Yang, Huibin ; Zhang, Qingyu ; Zhao, Yuxuan ; An, Ting ; Shi, Xiaojing

BACKGROUND AND OBJECTIVE:

Janus kinase (JAK) inhibitors (JAKinibs) are effective for inflammatory bowel disease (IBD), but their cardiovascular safety is inconclusive. We aim to assess the cardiovascular risks associated with JAKinibs in IBD patients.

PATIENTS AND METHODS:

Systematic searches of seven databases and ClinicalTrials.gov from inception to February 2024 were conducted. Outcomes included major adverse cardiovascular events (MACE), venous thromboembolism events (VTE) and cardiovascular events (CVE), which were separately evaluated based on whether or not the dose was considered. P-score was applied to rank interventions.

RESULTS:

A total of 26 trials involving 10,537 IBD patients were included, and results showed no significantly increased risk of MACE, VTE and CVE was associated with JAKinibs. However, when the dose was considered, Tofacitinib 5 mg BID (versus placebo) showed a trend towards an increased risk of MACE [odds ratio (OR)=1.05, 95% confidence interval (CI): 0.23-4.82], as well as Upadacitinib 30 mg QD (versus placebo) showed a trend towards increased risks of VTE (OR=1.36, 95% CI: 0.23-8.03) and CVE (OR=1.08, 95% CI: 0.24-4.85), and ranked higher than placebo for the risk of VTE [P-score=0.766 (versus 0.722)]. Notably, Deucravacitinib ranked lowest for all cardiovascular risks, and significantly decreased the risks of VTE (OR=0.03, 95% CI: 0.00-0.87) and CVE (OR=0.03, 95% CI: 0.00-0.87) compared with placebo.

CONCLUSIONS:

Although a trend of increased cardiovascular risks was found considering dose, no significantly increased cardiovascular risk was associated with JAKinibs in IBD patients, and Deucravacitinib significantly decreased the risks of VTE and CVE.

01 Dec 2025·IMMUNOLOGIC RESEARCH

Deucravacitinib as a monotherapy for concurrent management of psoriasis and chronic spontaneous urticaria

Article

Author: Li, Changxing ; Zhang, Xiaoying ; Zhang, Chenxi ; Liu, Yifei ; Xu, Bichun ; Liang, Jiali

Patients with autoimmune diseases are susceptible to developing a second autoimmune disorder. Psoriasis, a common autoimmune disease, frequently occurs alongside other autoimmune conditions in some individuals. We report the case of a young female patient diagnosed with plaque psoriasis, initially treated with secukinumab, and achieved complete skin clearance at 12 weeks. However, she experienced a decline in the efficacy of secukinumab, with recurrence of symptoms and subsequent development of chronic spontaneous urticaria (CSU) and was switched to treatment with deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor. The use of deucravacitinib resulted in a favorable therapeutic outcome, effectively managing both psoriasis and CSU 12 weeks after treatment. This case highlights the potential of deucravacitinib as a novel monotherapy for patients with both psoriasis and CSU.

271

News (Medical) associated with Deucravacitinib

19 Dec 2025

·www.fiercepharma.com

Fierce Pharma Asia—Daiichi ADCs' 1st-line nod, trial deaths; Takeda's TYK2 trial win

Enhertu's first-line breast cancer approval, unexpected death cases in a Daiichi Sankyo antibody-drug conjugate trial and positive readouts from Takeda's Sotyktu challenger made our news this week. In the last Fierce Pharma Asia weekly news roundup of 2025, Daiichi Sankyo scored a key FDA approval for AstraZeneca-partnered Enhertu in first-line HER2-positive breast cancer but paused a phase 3 trial of its Merck & Co.-partnered antibody-drug conjugate due to unexpected patient deaths. Takeda plans to file its TYK2 inhibitor for an FDA approval following a pair of positive phase 3 trials in psoriasis. And more.1. AZ, Daiichi score with FDA nod for Enhertu combo in 1st-line breast cancerThe FDA has approved AstraZeneca and Daiichi Sankyo’s Enhertu in combination with Roche’s Perjeta as the first new first-line treatment of HER2-positive metastatic breast cancer in more than a decade. In the Destiny-Breast09 trial, the combo significantly lowered the risk of progression or death by 44% compared with the traditional THP regimen.2. Patient deaths prompt partial hold for Daiichi-Merck’s global phase 3 ADC programDaiichi has paused enrollment in a phase 3 trial of its Merck & Co.-partnered B7-H3 antibody-drug conjugate, ifinatamab deruxtecan, after an unexpected number of deaths from interstitial lung disease. The partial clinical hold comes as the pharma partners said they were aiming for an accelerated approval for the candidate for pretreated small cell lung cancer based on a phase 2 readout.3. Takeda looks to 2026 FDA filing for its Sotyktu rival zasocitinib after phase 3 successTakeda said its oral TYK2 inhibitor zasocitinib, a potential competitor to Bristol Myers Squibb’s Sotyktu, succeeded in two phase 3 trials in moderate to severe plaque psoriasis. The drug beat placebo on the trials’ co-primary endpoints of static Physician Global Assessment 0/1 and the Psoriasis Area and Severity Index 75 at Week 16. The company plans to file for an FDA approval. 4. Biosecure Act heads to Trump's desk with defense spending bill after Senate voteBoth the House of Representatives and the Senate have passed the annual defense bill that includes the revamped Biosecure Act. President Donald Trump is expected to sign the massive defense package into law. Once enacted, the updated Biosecure Act will raise hurdles for life sciences companies from China.5. Fosun signs up to take on China's Green Valley, revive controversial Alzheimer's medFosun Pharma is spending about $200 million to take a 53% stake in Green Valley Pharmaceuticals, aiming to revive the latter’s controversial Alzheimer’s disease med, sodium oligomannate (GV-971), after Chinese regulators opted not to renew the drug’s conditional approval. The Shanghai Stock Exchange sent Fosun a regulatory letter related to the proposed transaction. Such a letter typically reminds a public company of potential regulatory breaches.6. Harbour BioMed docks with BMS in antibody discovery, development deal worth up to $1.1BBristol Myers Squibb signed on China’s Harbour BioMed to discover multispecific antibodies. Harbour could receive payments totaling $90 million plus development and commercial milestones of up to $1.035 billion. Before BMS, Harbour had forged collaborations with Otsuka and AstraZeneca earlier this year.7. Sanofi signs $1B biobucks pact for Alzheimer's asset in 2nd biotech deal of the daySanofi has signed a licensing deal worth up to $1.04 billion with South Korean biotech Adel. The pact focuses on ADEL-Y01, a tau-targeting antibody for Alzheimer’s disease. Sanofi will pay $80 million upfront for the clinical-stage asset and related backup compounds. Rather than broadly targeting tau, the drug focuses on tau acetylated at lysine-280.Other News of Note: 8. AI drug designer Insilico Medicine aims to generate nearly $300M in Hong Kong IPO9. Keytruda, Padcev keep winning streak with another patient survival benefit in bladder cancer10. Yarrow blooms with $1.37B deal, landing autoimmune thyroid disease drug from China's GenSci11. Yarrow to go public in reverse merger with Vyne (release)12. Boehringer inks AI protein design pact with Korea’s Galux (release)13. Hansoh sells regional rights to EGFR inhibitor to Glenmark in potential $1B deal (release)14. Lilly to help Korea’s Medi&Gene advance an obesity asset (release)

License out/inPhase 3Drug ApprovalADC

19 Dec 2025

·pharma.economictimes.indiatimes.com

Takeda's AI-crafted psoriasis pill succeeds in late-stage studies

REUTERS/Kim Kyung-Hoon/File Photo Japan's Takeda Pharmaceutical said on Thursday its experimental pill for a type of skin disease, developed using artificial intelligence, succeeded in two late-stage studies. More than half the plaque psoriasis patients across the studies showed clear or almost clear skin after 16 weeks of treatment with the once-daily drug, zasocitinib, the company said. Takeda plans to file marketing applications with the U.S. Food and Drug Administration and other regulatory authorities in 2026. If approved, zasocitinib would join a crowded plaque psoriasis market featuring well-established oral rivals like Bristol Myers' Sotyktu and Amgen's Otezla, plus injectables including Johnson & Johnson's Tremfya, AbbVie's Skyrizi, and Novartis' Cosentyx. Takeda's pill offers a convenient daily pill alternative alongside Sotyktu and Otezla in a market dominated by injectable drugs for treating plaque psoriasis, in which red, scaly patches occur on the skin due to an overactive immune system. The company is banking on the blockbuster potential of zasocitinib to help fill a revenue gap it faces after its inflammatory bowel disease drug Entyvio loses key patents at the end of the decade. Takeda in January had said it expects zasocitinib, if approved, to generate peak annual sales in the range of $3 billion to $6 billion. The drugmaker acquired zasocitinib from drug developer Nimbus Therapeutics in 2022 in a deal worth up to $6 billion. Nimbus had identified the compound with the help of AI, a trend picking up pace in the pharmaceutical industry as companies seek to accelerate development of medicines. The drug was generally well tolerated and outperformed placebo and Amgen's Otezla, with treatment responses strengthening through week 24. (Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Leroy Leo)

AcquisitionDrug ApprovalClinical Result

19 Dec 2025

·www.biospace.com

Takeda’s $4B Nimbus Bet Pays Off With ‘Best-in-Class’ Phase III Plaque Psoriasis Data

iStock, Veronique D With zasocitinib, Takeda is looking to challenge Bristol Myers Squibb’s kinase inhibitor Sotyktu, for which the Japanese pharma is running a head-to-head study in plaque psoriasis. Takeda expects to zasocitinib’s FDA approval next year. Takeda’s oral drug candidate zasocitinib significantly eased disease severity in two late-stage plaque psoriasis studies, setting the Japanese pharma up to challenge Bristol Myers Squibb in this indication. “The oral psoriasis segment is projected to exceed $5B by 2030,” analysts at Jefferies told investors in a Thursday note, explaining that patients are partial to pills over injectables. In this area, zasocitinib’s “strong efficacy and safety pro regulatory approval,” the firm continued. Takeda expects to new drug application for zasocitinib at the start of its 2026 fiscal year, which begins in April. Takeda acquired zasocitinib from Nimbus Therapeutics for $4 billion at the end of 2022, outcompeting “almost every biopharmaceutical company” to get it, according to Andy Plump, Takeda’s head of research and development. Across the two Phase III LATITUDE studies, Takeda enrolled more than 1,800 adults with moderate to severe plaque psoriasis. Both studies compared zasocitinib with placebo and Amgen’s Otezla. Data were sparse in the pharma’s Thursday release , in which it noted that “on average about 30 percent” of treated patients achieved completely clear skin, or a score of 100 on the Psoriasis Area and Severity Index (PASI). Meanwhile, “more than half” of patients hit PASI 90, indicating clear or almost clear skin. Despite the lack of details, Jefferies said that zasocitinib “demonstrated best-in-class Ph3 results,” which in turn point to its “potential to redefine the oral psoriasis market.” Zasocitinib is an AI-designed molecule, something which trial organizers said helped make its targeting “ 1.7 million times ” more selective than other drugs for psoriasis. After a reshuffle of pipeline priorities and dropping its entire cell therapy program this fall, Takeda re-upped a pact with AI-discovery firm Nabla Bio to refill its early pipeline. With zasocitinib, Takeda is stepping up to Bristol Myers Squibb and its oral tyrosine kinase inhibitor Sotyktu, which was approved in September 2022 for plaque psoriasis. Sotyktu made $246 million worldwide for BMS last year, a 45% year-on-year increase. Takeda is running a Phase III head-to-head study that compares zasocitinib against Sotyktu in moderate to severe plaque psoriasis. The trial is expected to be completed in July next year. Aside from Sotyktu, Takeda’s zasocitinib will also be going up against Johnson & Johnson’s icotrokinra, which in March this year hit a 50% PASI 90 response. Truist in its note said that zasocitinib appears “comparable” to icotrokinra, however noting that J&J’s molecule “has first mover advantage with PDUFA expected sometime in 2026.”

Phase 3AcquisitionClinical ResultDrug ApprovalCell Therapy

100 Deals associated with Deucravacitinib

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KEGG	Wiki	ATC	Drug Bank
D11817	-	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Erythrodermic psoriasis	Japan	Bristol-Myers Squibb KK	26 Sep 2022
Psoriasis vulgaris	Japan	Bristol-Myers Squibb KK	26 Sep 2022
Pustular psoriasis	Japan	Bristol-Myers Squibb KK	26 Sep 2022
Plaque psoriasis	United States	Bristol Myers Squibb Co.	09 Sep 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Arthritis, Psoriatic	NDA/BLA	United States	Bristol Myers Squibb Co.	21 Jul 2025
Juvenile Idiopathic Arthritis	Phase 3	United States	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	China	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Brazil	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Bulgaria	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Czechia	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Germany	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Italy	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Romania	Bristol Myers Squibb Co.	13 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Spain	Bristol Myers Squibb Co.	13 Mar 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05710185 (CTgov)	Phase 4	Pustulosis of Palms and Soles	3	Deucravacitinib	dwstocsnhd = ftwdcqiywd slmnkjlxaz (tsmymnkqva, oywwtskcok - jtyskzixhu) View more	-	16 Dec 2025
NCT03624127 \| NCT03611751 (POETYK PSO-2, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Plaque psoriasis	422	Placebo	pfkwoavozf(tgewgaxlbr) = odvcpdrujd cmlbcwnchg (uloophacbi )	Positive	05 Dec 2025
				Deucravacitinib 6 mg once daily	pfkwoavozf(qtirplbxhy) = lwoijqzjzv kuiznfsbob (oknrqihtgj ) View more
NCT06476834 (CTgov)	Phase 4	-	8	Deucravacitinib	nihygbzngh(zxsmsfsvxm) = jkutsciepw svupahwpuk (yeinaslnma, 59.5) View more	-	03 Dec 2025
NCT04908202 (POETYK PsA-1, ACR2025)	Phase 3	Arthritis, Psoriatic	670	Deucravacitinib 6 mg QD	oepjederkj(czpnrrkzsx) = kznjeestyg nftjacfwby (jytkxisyck )	Positive	24 Oct 2025
				Placebo	vliizwxqwv(vhfyxkofln) = wqjoieztcc hzlizxczyl (zlglunwlmh ) View more
NCT04908202 (POETYK PsA-1, ACR2025)	Phase 3	Arthritis, Psoriatic	1,294	Deucravacitinib 6 mg	pmykfluswj(mcobfnsugg) = hcjgfroexu hrgnifvnwr (txknbiqema ) View more	Positive	24 Oct 2025
				Placebo	pmykfluswj(mcobfnsugg) = ifyadracdo hrgnifvnwr (txknbiqema ) View more
NCT04857034 (PAISLEY CLE, ACR2025)	Phase 2	Lupus Erythematosus, Cutaneous IFN-5 \| IFN-γ \| inflammation	78	Deucravacitinib 3 mg twice daily	ombmmrwjyu(dkqqqlelzn) = xpmemqlluf emzmzeljyw (mttvfmparr )	Positive	24 Oct 2025
				Deucravacitinib 6 mg twice daily	ombmmrwjyu(dkqqqlelzn) = bkoaapvfpz emzmzeljyw (mttvfmparr )
NCT04857034 (PAISLEY DLE/SCLE, ACR2025)	Phase 2	Lupus Erythematosus, Cutaneous	32	Deucravacitinib 3 mg BID	gghotmoiik(usfcqafgly) = hnrixxoaqs shzwdvcxyb (syeevuiaag ) View more	Positive	24 Oct 2025
NCT03252587 (PAISLEY SLE, ACR2025)	Phase 2	Systemic Lupus Erythematosus	363	Deucravacitinib 3 mg BID	ldjciohayd(hctecnurhn) = occurred in 13.4%, 11.4%, and 17.3% of patients who received deucravacitinib 3 mg BID, 6 mg BID, and 12 mg QD, respectively. rmignhyypk (ihzdoeardh ) View more	Positive	24 Oct 2025
				Deucravacitinib 6 mg BID
NCT04908202 (POEYTK PsA-1 \| POETYK PsA-1, CTgov)	Phase 3	Arthritis, Psoriatic	670	Deucravacitinib (Placebo-Controlled Period - Deucravacitinib 6 mg QD)	abidtzgngx = yhfkhjxpog idpyibquny (oyipllrwrt, bljzexynfx - nhggphzqvw) View more	-	24 Oct 2025
				placebo (Placebo-Controlled Period - Placebo)	abidtzgngx = wvgudrtfqn idpyibquny (oyipllrwrt, qhgyxoosiz - qceyjipzvw) View more
NCT03252587 \| NCT03920267 (PAISLEY LTE, ACR2025) Manual	Phase 2	Systemic Lupus Erythematosus	363	Placebo (to week 48)	pocgsysxxx(osbczedrpv) = bqskhbhozx jtzfzthoon (refwsmmntq ) View more	Positive	13 Oct 2025
				Deucravacitinib (3 mg BID, through W226)	pocgsysxxx(osbczedrpv) = wljihddcdc jtzfzthoon (refwsmmntq ) View more