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Details:
Vtama (tapinarof) cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant and steroid-free, topical cream, for the treatment of atopic dermatitis in adults and children 2 years of age and older.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
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 February 14, 2024
Details:
Vtama (tapinarof) cream is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant and steroid-free, topical cream. It is being evaluated in phase 3 clinical trials for Atopic Dermatitis.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
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 January 11, 2024
Details:
Vtama (tapinarof) is a novel, aryl hydrocarbon receptor agonist in development as a once-daily, cosmetically elegant and steroid-free, topical cream, for the treatment of plaque psoriasis in the head and neck region.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
Highest Development Status: Phase IVProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2023
Details:
Vtama (tapinarof Cream 1%) is the first-in-class, steroid-free, once-daily topical treatment for moderate to severe atopic dermatitis in adults and children as young as two years old.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
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 May 16, 2023
Details:
Vtama (tapinarof Cream 1%) is the first-in-class, steroid-free, once-daily topical treatment for extensive atopic dermatitis in adults and children as young as two years old.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
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 15, 2023
Details:
Vtama (tapinarof) is an aryl hydrocarbon receptor (AhR) agonist. It is the first-in-class, steroid-free, once-daily topical treatment for extensive atopic dermatitis in adults and children as young as two years old.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
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 February 13, 2023
Details:
Vtama (tapinarof Cream 1%) is the first-in-class, steroid-free, once-daily topical treatment for extensive atopic dermatitis in adults and children as young as two years old.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
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 12, 2023
Details:
VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. VTAMA cream is the first and only steroid-free topical medication in its class, and it can be used long-term anywhere on the affected skin.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 22, 2022
Details:
The study’s objective was to characterize the pharmacokinetics (PK) and safety of VTAMA (tapinarof) cream under maximal usage conditions in pediatric subjects with atopic dermatitis.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2022
Details:
VTAMA (tapinarof) cream, 1% is a topical prescription treatment approved by the FDA for adults with plaque psoriasis and is safe for regular, long-term use on all affected external skin areas.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
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 13, 2022
Details:
Following 25 years of minimal innovation in topical psoriasis treatments, approved VTAMA (tapinarof) cream for topical treatment of plaque psoriasis in adults.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 24, 2022
Details:
VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist,is a non-steroidal topical that is a new chemical entity approved in the US for the topical treatment of plaque psoriasis in adults.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Innovaderm
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 21, 2022
Details:
VTAMA® (tapinarof) Cream, 1% demonstrated continued improvement beyond the 12-week double blind treatment period in the pivotal studies with up to 41% of patients (n=312/763) ultimately achieving complete disease clearance.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2022
Details:
In pivotal Phase 3 program, VTAMA (Tapinarof) cream met all primary and secondary endpoints and demonstrated highly statistically significant improvement versus vehicle in PGA score with 36% of patients versus 6% in vehicle in PSOARING 1.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
Phase 3 PSOARING 3 long-term extension study results demonstrating durable improvements across efficacy outcomes, quality of life measures, and tolerability scores with investigational tapinarof cream 1% once daily (QD) for the treatment of plaque psoriasis in adults.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
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 25, 2022
Details:
The poster will report secondary efficacy data from PSOARING 3 for tapinarof cream, including change in percentage body surface area (%BSA) affected by visit, change in Psoriasis Area and Severity Index (PASI) score by visit, and PASI response rates at Week 40.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
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 11, 2022
Details:
Patients from PSOARING 3 who completed the survey preferred DMVT-505 (tapinarof) to prior topical treatments with 81.7% considering it more effective and demonstrated consistent high rates of satisfaction and positive perception of treatment.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
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 January 15, 2022
Details:
New patient satisfaction data from PSOARING 3, the long-term extension study of DMVT-505 (tapinarof) cream for the treatment of plaque psoriasis in adults, will be presented.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
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 January 07, 2022
Details:
The study results demonstrated that tapinarof cream was well tolerated long term, with a safety profile consistent with the pivotal studies and previously reported interim analysis of data from PSOARING 3.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
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 September 30, 2021
Details:
DMVT-505 (tapinarof), is an investigational, novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
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 September 09, 2021
Details:
Proceeds to be used to fund all milestone payments associated with approval and launch of Tapinarof for treatment of psoriasis, as well as to accelerate investment in commercial preparation.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Marathon Asset Management
Deal Size: $200.0 million Upfront Cash: Undisclosed
Deal Type: Financing June 07, 2021
Details:
Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: IQVIA
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2021
Details:
Roivant have conducted eight consecutive positive Phase 3 studies with two FDA approvals, one is DMVT-505 (Tapinarof). Roivant is also a leader in computational drug discovery through its combination of computational physics and machine learning-based platforms for the in silico design of small molecules.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Montes Archimedes Acquisition Corporation
Deal Size: $200.0 million Upfront Cash: Undisclosed
Deal Type: Merger May 03, 2021
Details:
The posters feature important secondary efficacy endpoints and patient-reported outcomes data from patients with mild, moderate, or severe chronic plaque psoriasis after 12 weeks of treatment with tapinarof cream 1% dosed once daily (QD) compared to vehicle QD.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: IQVIA
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 23, 2021
Details:
57.3% (298/520) of subjects who entered the study with a Physician Global Assessment (PGA) score ≥ 2 achieved a PGA score of 0 or 1, which indicates tapinarof’s increased therapeutic effect beyond the 12-week double blind treatment periods in PSOARING 1 and 2.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: IQVIA
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2021
Details:
The presentation, titled “Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Efficacy and Safety in Two Pivotal Phase 3 Trials,” will be delivered at the 29th European Academy of Dermatology and Venereology (EADV) Virtual Congress.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
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:
The two presentations will cover data from Dermavant’s successful Phase 3 PSOARING pivotal trials in addition to a maximal use pharmacokinetics study.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
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 22, 2020
Details:
Derm-Biome's topical drugs produced significant, and dose dependent inhibitory effects in a well established mouse model of psoriasis. The drug showed comparable inhibitory effects to tapinarof over a similar range of concentrations.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 06, 2020
Details:
In PSOARING 1 and PSOARING 2, tapinarof cream demonstrated highly statistically significant improvement in Physician Global Assessment (PGA) score of clear or almost clear with a minimum 2-grade improvement compared to vehicle from baseline at Week 12.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
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 26, 2020
Details:
The publication highlighted the secondary efficacy and patient-reported outcomes from its Dermavant's Phase 2b randomized clinical trial of tapinarof cream for the treatment of atopic dermatitis.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: DMVT-505
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2020
Details:
The long-term safety study is part of a Phase 3 program for Tapinarof, which also includes Psoaring 1 and Psoaring 2, two identical Phase 3 clinical trials to evaluate the efficacy and safety of Tapinarof in adult patients with Plaque Psoriasis.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Undisclosed
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 09, 2020
Details:
A significantly higher proportion of patients treated with tapinarof 1% QD reported very or moderately improved psoriasis symptoms and psoriasis-related pruritus compared with those receiving vehicle QD at Week 12.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Undisclosed
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 May 26, 2020
Details:
Psoaring 1 and Psoaring 2 are two identical phase 3 clinical trials that have enrolled a combined 1,025 patients to evaluate the safety and efficacy of tapinarof in adults with plaque psoriasis.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Undisclosed
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 April 02, 2020
Details:
A license agreement to develop, register and market tapinarof in Japan for the treatment of dermatological diseases and conditions, including psoriasis and atopic dermatitis.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Japan Tobacco
Deal Size: $113.0 million Upfront Cash: $60.0 million
Deal Type: Licensing Agreement January 15, 2020
Details:
Under the agreement, JT and its subsidiary, Torii Pharmaceutical, receive rights to develop and commercialize Vtama (tapinarof), a potential first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent, for psoriasis and atopic dermatitis in Japan.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Product Name: Vtama
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Japan Tobacco
Deal Size: $113.0 million Upfront Cash: $60.0 million
Deal Type: Licensing Agreement January 15, 2020
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