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Undisclosed"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Immunology","country":"FRANCE","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Belumosudil","moa":"Rho-associated coiled-coil kinase 2","graph1":"Immunology","graph2":"Phase II","graph3":"Sanofi","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Immunology","amount2New":0,"dosageForm":"Oral","sponsorNew":"Sanofi \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Sanofi \/ Not Applicable"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Immunology","country":"FRANCE","productType":"Small molecule","year":"2020","type":"Not Applicable","leadProduct":"Belumosudil","moa":"Rho-associated coiled-coil kinase 2","graph1":"Immunology","graph2":"Phase II","graph3":"Sanofi","amount2":0,"highestDevelopmentShortName":"Ph 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\/ Not Applicable"},{"orgOrder":0,"company":"Sanofi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Immunology","country":"FRANCE","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Belumosudil","moa":"ROCK 2","graph1":"Immunology","graph2":"Phase II","graph3":"Sanofi","amount2":0,"highestDevelopmentShortName":"Ph II","therapeuticAreaShortName":"Immunology","amount2New":0,"dosageForm":"Oral","sponsorNew":"Sanofi \/ Not Applicable","highestDevelopmentStatusID":"8","companyTruncated":"Sanofi \/ Not Applicable"},{"orgOrder":0,"company":"Onco360","sponsor":"Not Applicable","pharmaFlowCategory":"DU","therapeuticArea":"Immunology","country":"U.S.A","productType":"Small molecule","year":"2021","type":"Not Applicable","leadProduct":"Belumosudil","moa":"Rho-associated coiled-coil kinase 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Find Clinical Drug Pipeline Developments & Deals for Belumosudil Mesylate

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                          01

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Study Phase : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Details : Results demonstrate strong, but not universal, correlation between organ clinical responses and clinically meaningful improvements in patient-reported outcomes from a pooled analysis of ROCKstar and KD025-208 for Rezurock (belumosudil) clinical trials.

                          Brand Name : Rezurock

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 21, 2022

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Sanofi Company Banner

                          02

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Study Phase : Approved

                          Sponsor : Sanofi

                          Deal Size : $1,900.0 million

                          Deal Type : Acquisition

                          Details : The acquisition supports Rezurock™(belumosudil) to its transplant portfolio. Rezurock is a FDA-approved, treatment for chronic graft-versus-host disease for adult and pediatric patients 12 years and older who have failed at least two prior lines of sys...

                          Brand Name : Rezurock

                          Molecule Type : Small molecule

                          Upfront Cash : $1,900.0 million

                          September 08, 2021

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Highest Development Status : Approved

                          Sponsor : Sanofi

                          Deal Size : $1,900.0 million

                          Deal Type : Acquisition

                          Sanofi Company Banner

                          03

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Study Phase : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Details : The Phase 2 study (KD025-215) will enroll up to 15 adults with dcSSc who will receive orally administered belumosudil 200 mg twice daily (BID). Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2).

                          Brand Name : KD025-209

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 01, 2021

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Sanofi Company Banner

                          04

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Study Phase : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Details : In a notice received from the FDA on March 9, 2021, the Company was informed that the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of belumosudil has been extended to August, 2021.

                          Brand Name : KD025

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          March 11, 2021

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Sanofi Company Banner

                          05

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Study Phase : Phase II

                          Sponsor : Cantor Fitzgerald & Co

                          Deal Size : $240.0 million

                          Deal Type : Public Offering

                          Details : Kadmon plans to use a part of the proceeds to prepare to commercialize belumosudil for chronic graft-vs-host disease in the U.S; for its clinical-stage product candidates; for discovery and preclinical studies of other product candidates; and for general...

                          Brand Name : KD025

                          Molecule Type : Small molecule

                          Upfront Cash : Undisclosed

                          February 16, 2021

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Highest Development Status : Phase II

                          Sponsor : Cantor Fitzgerald & Co

                          Deal Size : $240.0 million

                          Deal Type : Public Offering

                          Sanofi Company Banner

                          06

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Study Phase : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Details : The presentation will include 12-month efficacy and safety data and key secondary endpoints including duration of response, Failure-Free Survival, steroid dose reductions and quality-of-life improvements.

                          Brand Name : KD025

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          November 04, 2020

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Sanofi Company Banner

                          07

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Study Phase : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Details : The FDA has granted Breakthrough Therapy Designation to belumosudil for the treatment of patients with cGVHD who failed two or more lines of systemic therapy.

                          Brand Name : KD025

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          September 30, 2020

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Sanofi Company Banner

                          08

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Study Phase : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Details : Belumosudil is being studied in an ongoing double-blind, placebo-controlled Phase 2 clinical trial in adults with SSc. The study is enrolling 60 patients to receive belumosudil 200 mg QD, belumosudil 200 mg BID or placebo for 24 weeks.

                          Brand Name : KD025

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          September 08, 2020

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Sanofi Company Banner

                          09

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Study Phase : Phase II

                          Sponsor : Undisclosed

                          Deal Size : $50.0 million

                          Deal Type : Public Offering

                          Details : The proceeds from the offering will be used to advance belumosudil toward a NDA filing with the U.S FDA and support related pre-commercialization activities and provide additional working capital for general corporate purposes.

                          Brand Name : Undisclosed

                          Molecule Type : Small molecule

                          Upfront Cash : Undisclosed

                          June 05, 2020

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Highest Development Status : Phase II

                          Sponsor : Undisclosed

                          Deal Size : $50.0 million

                          Deal Type : Public Offering

                          Sanofi Company Banner

                          10

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Study Phase : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Details : Belumosudil achieved clinically meaningful and statistically significant Overall Response Rates of 73% with 200 mg once daily and 74% with 200 mg twice daily. Responses were achieved across key patient subgroups and complete responses were observed in al...

                          Brand Name : Undisclosed

                          Molecule Type : Small molecule

                          Upfront Cash : Not Applicable

                          May 21, 2020

                          Lead Product(s) : Belumosudil

                          Therapeutic Area : Immunology

                          Highest Development Status : Phase II

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

                          Sanofi Company Banner