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World leader in Janus kinase (JAK) inhibition, transforming chronic inflammatory diseases at a molecular level

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1993

A scientist in Pfizer’s immunology group attends the FASEB Summer Conference on Lymphocytes and Antibodies and discovers the potential of JAK enzymes as drug targets[1]

NIH Headquaters Bethesda, MD

1996

The National Institutes of Health initiates a partnership with Pfizer to evaluate experimental compounds based on JAK inhibition for autoimmune disease[2]

1997

Medicinal chemistry program initiated at Pfizer with the goal of identifying a prototype molecule with high selectivity and potency against JAK[3]

2000

Based on positive laboratory findings, Pfizer nominates CP-690,550 (tofacitinib)—the first JAK inhibitor developed to target autoimmune disease—for clinical development[3]

2005

Initiation of the first in-human study evaluating a JAK inhibitor (CP-690,550, tofacitinib) for the treatment of an autoimmune disease (rheumatoid arthritis)[4]

2008

  • Results from a phase 2 study of tofacitinib in rheumatoid arthritis serve as the first proof of concept that JAK inhibition may be effective for the treatment of autoimmune diseases[5]Oct
  • Initiation of clinical development program studying tofacitinib for the treatment of ulcerative colitis[6]Dec

2012

  • Initiation of clinical development program studying tofacitinib for the treatment of psoriatic arthritis[7]Mar
  • FDA approves tofacitinib to treat adults with moderately to severely active rheumatoid arthritis who have not responded adequately to, or are intolerant of, methotrexate[8]Nov

2013

  • Initiation of clinical development program studying tofacitinib for the treatment of juvenile idiopathic arthritis[9]Mar
  • Initiation of clinical development program studying tofacitinib for the treatment of ankylosing spondylitis[10]Apr
  • Initiation of clinical development program studying tofacitinib for the treatment of atopic dermatitis[11]Dec

2016

  • FDA approves extended-release tofacitinib for the treatment of adults with moderately to severely active rheumatoid arthritis who have not responded adequately to, or are intolerant of, methotrexate[12] Feb
  • Initiation of clinical development program studying the JAK1 inhibitor, abrocitinib, for the treatment of atopic dermatitis[13] Apr
  • Initiation of clinical development program studying the JAK1/TYK2 inhibitor, brepocitinib, for the treatment of plaque psoriasis[14] Dec
  • Initiation of clinical development program studying brepocitinib for the treatment of alopecia areata[15]
  • Initiation of clinical development program studying the JAK3/TEC inhibitor, ritlecitinib, for the treatment of alopecia areata[16]

2017

  • FDA approves tofacitinib and tofacitinib extended-release tablets (XR) for the treatment of adult patients with active psoriatic arthritis who have not responded adequately to, or are intolerant of, methotrexate or other disease-modifying antirheumatic drugs (DMARDs)[17] Dec

2018

  • Pfizer receives breakthrough therapy designation for oral JAK1 inhibitor abrocitinib, in atopic dermatitis[18] Feb
  • FDA approves tofacitinib for the treatment of adult patients with moderately to severely active ulcerative colitis who have not responded adequately to, or are intolerant of, tumor necrosis factor (TNF) blockers[19] May
  • Pfizer receives breakthrough therapy designation for oral JAK3/TEC inhibitor, ritlecitinib, in alopecia areata[20] Sep
  • Initiation of clinical development program studying ritlecitinib for the treatment of vitiligo[21] Dec

2019

  • Theravance Biopharma and Pfizer enter a global license agreement for Theravance’s skin-targeted, locally acting pan JAK inhibitor program, for further development by Pfizer[22] Dec
  • FDA approves tofacitinib extended-release tablets (XR) for the treatment of adult patients with moderately to severely active ulcerative colitis who have not responded adequately to, or are intolerant of, TNF blockers[23]
  • Initiation of clinical development program studying brepocitinib for the treatment of hidradenitis suppurativa[24]

2020

  • FDA approves tofacitinib for the treatment of polyarticular course juvenile idiopathic arthritis in patients 2 years of age and older[25]Sep
  • FDA grants priority review of abrocitinib for the treatment of adolescents and adults with moderate to severe atopic dermatitis[26] Oct

Forbes.com.
https://www.forbes.com/sites/johnlamattina/2012/05/10/a-brief-history-of-tofacitinib/?sh=2b97c70c5a44.
Accessed January 14, 2021.

Pfizer Press Release.
https://www.pfizer.com/news/newyorktimes_nih_policy.
Accessed January 17, 2021.

ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?cond=Rheumatoid+Arthritis&term=CP-+690%2C550%3B+tofacitinib&cntry=&state=&city=&dist=&Search=Search&phase=1.
Accessed January 17, 2021.

Reuters.com.
https://www.reuters.com/article/us-arthritis-pfizer-idUKTRE49P01820081026?edition-redirect=uk.
Accessed February 12, 2021.

ClinicalTrial.gov.
https://clinicaltrials.gov/ct2/results?term=CP-+690%2C550&cond=Ulcerative+Colitis&age_v=&gndr=&type=&rslt=&phase=1&Search=Apply.
Accessed January 17, 2021.

ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?cond=Psoriatic+Arthritis&term=CP-+690%2C550%3B+tofacitinib&cntry=&state=&city=&dist=&Search=Search.
Accessed January 17, 2021.

Pfizer Press Release.
https://investors.pfizer.com/investor-news/press-release-details/2012/US-Food-And-Drug-Administration-Approves-Pfizers-XELJANZ-tofacitinib-citrate-for-Adults-with-Moderately-to-Severely-Active-Rheumatoid-Arthritis-RA-Who-Have-Had-an-Inadequate-Response-or-Intolerance-to-Methotrexate/default.aspx.
Accessed March 10, 2021.

ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?cond=JIA&term=CP-+690%2C550%3B+tofacitinib&cntry=&state=&city=&dist=&Search=Search.
Accessed January 17, 2021.

ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?cond=Ankylosing+Spondylitis&term=CP-+690%2C550%3B+tofacitinib&cntry=&state=&city=&dist=&Search=Search.
Accessed January 17, 2021.

ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?cond=atopic+dermatitis&term=CP-+690%2C550%3B+tofacitinib&cntry=&state=&city=&dist=&Search=Search.
Accessed January 17, 2021.

Pfizer Press Release.
pfizer_announces_fda_approval_of_xeljanz_xr_tofacitinib_citrate_extended_release_tablets_the_first_and_only_once_daily_oral_jak_inhibitor_treatment_for_rheumatoid_arthritis.
Accessed January 17, 2021.

ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?term=PF-04965842&cond=Atopic+Dermatitis&age_v=&gndr=&type=&rslt=&phase=1&Search=Apply.
Accessed January 17, 2021.

ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?term=PF-06700841&cond=psoriasis&age_v=&gndr=&type=&rslt=&phase=1&Search=Apply.
Accessed January 17, 2021.

ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?cond=alopecia&term=PF-06700841&cntry=&state=&city=&dist=&Search=Search&phase=1.
Accessed January 17, 2021.

Pfizer Press Release.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_fda_approval_of_xeljanz_tofacitinib_and_xeljanz_xr_for_the_treatment_of_active_psoriatic_arthritis.
Accessed March 10, 2021.

Pfizer Press Release.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_breakthrough_therapy_designation_from_fda_for_pf_04965842_an_oral_jak1_inhibitor_for_the_treatment_of_patients_with_moderate_to_severe_atopic_dermatitis.
Accessed January 14, 2021.

Pfizer Press Release.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_u_s_fda_approves_xeljanz_tofacitinib_for_the_treatment_of_moderately_to_severely_active_ulcerative_colitis-0.
Accessed January 14, 2021.

Pfizer Press Release.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_breakthrough_therapy_designation_from_fda_for_pf_06651600_an_oral_jak3_inhibitor_for_the_treatment_of_patients_with_alopecia_areata.
Accessed January 14, 2021.

ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?cond=Vitiligo&term=PF-06651600+&cntry=&state=&city=&dist=&Search=Search.
Accessed January 17, 2021.

Pfizer Press Release.
https://www.pfizer.com/news/press-release/press-release-detail/theravance_biopharma_and_pfizer_inc_enter_global_license_agreement_for_skin_targeted_locally_acting_pan_janus_kinase_jak_inhibitor_program.
Accessed January 15, 2021.

Pfizer Press Release.
https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_xeljanz_xr_tofacitinib_extended_release_tablets_for_the_treatment_of_ulcerative_colitis.
Accessed January 14, 2021.

ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?cond=Hidradenitis&term=PF-06700841&cntry=&state=&city=&dist=&Search=Search&phase=1.
Accessed January 17, 2021.

Pfizer Press Release.
https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-xeljanzr-tofacitinib-treatment.
Accessed December 12, 2020.

Pfizer Press Release.
https://www.pfizer.com/news/press-release/press-release-detail/fda-grants-priority-review-and-ema-accepts-regulatory.
Accessed December 12, 2020.

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