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Details:
Under the partnership, Glenmark and Pfizer will co‐market abrocitinib, a Janus kinase 1 (JAK1) inhibitor, provides rapid itch relief and sustained disease control in India under the brand names Jabryus and Cibinqo, respectively.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: Cibinqo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 31, 2024
Details:
CIBINQO (abrocitinib) is an oral inhibitor of Janus kinase 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: Cibinqo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 10, 2023
Details:
FDA approval for Cibinqo (Abrocitinib) JAK1 inhibitor, was based on the results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: Cibinqo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 14, 2022
Details:
The approval of Cibinqo (Abrocitinib) was based on the results of clinical studies for the treatment of moderate-to-severe atopic dermatitis (AD) in adults demonstrated meaningful improvements across measures of symptom relief.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: Cibinqo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 10, 2021
Details:
Abrocitinib is oral small molecule that selectively inhibits JAK1. CHMP adopted positive opinion for marketing authorization to treat moderate to severe atopic dermatitis (AD), and CHMP also recommends XELJANZ® (tofacitinib) approval for treatment of ankylosing spondylitis.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: Cibinqo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2021
Details:
Pfizer Inc today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for CIBINQO® (abrocitinib).
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: Cibinqo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2021
Details:
Abrocitinib 200mg was administered by once-daily oral tablet and dupilumab was administered by subcutaneous injection every other week following a 600mg induction dose.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: PF-04965842
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2021
Details:
Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: PF-04965842
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2021
Details:
Patients were randomized into one of three arms: 200mg, 100mg, or placebo. Both doses of abrocitinib met the primary endpoint, resulting in significantly fewer patients experiencing flaring, compared to those randomized to placebo.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: PF-04965842
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2020
Details:
Filings based on robust abrocitinib clinical trial data demonstrating significant symptom improvement versus placebo as well as a consistent safety profile.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: PF-04965842
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2020
Details:
Results showed that the percentage of patients achieving each co-primary efficacy endpoint at Week 12 was statistically significantly higher with both doses of abrocitinib than with placebo.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: PF-04965842
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2020
Details:
Abrocitinib met all key endpoints,demonstrating statistically superior improvements in skin clearance, disease extent and severity, and itch compared to placebo.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: PF-04965842
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2020
Details:
JADE COMPARE trial met all co-primary endpoints Study included dupilumab in active control arm Safety profile for abrocitinib consistent with previous studies.
Lead Product(s): Abrocitinib
Therapeutic Area: Dermatology Product Name: PF-04965842
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2020
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