Find Musculoskeletal Drugs in Phase III Clinical Development

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            Lead Product(s): PF-06939926

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 15, 2020

            Details:

            The preliminary data from 9 ambulatory boys with DMD, aged 6 to 12 indicate that the intravenous administration of PF-06939926 was well-tolerated during the infusion period, with encouraging efficacy and manageable safety events.

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            Lead Product(s): PF-06939926

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 10, 2020

            Details:

            First ever Phase III gene therapy clinical trial for Duchenne muscular dystrophy.

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            Lead Product(s): Abaloparatide

            Therapeutic Area: Musculoskeletal Product Name: BA058

            Highest Development Status: Phase III Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 08, 2020

            Details:

            The study was designed to look at the effects on bone mineral density of abaloparatide delivered via a novel transdermal device (“abaloparatide-patch”) compared with the current subcutaneous formulation, marketed as TYMLOS®.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            Both of the current Phase 3 trials are studying TNX-102 SL at a dose of 5.6 mg which is twice the 2.8 mg dose used in the Company’s prior Phase 2 and 3 studies in fibromyalgia.

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            Lead Product(s): JTA-004

            Therapeutic Area: Musculoskeletal Product Name: JTA-004

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $1.1 million Upfront Cash: Undisclosed

            Deal Type: Funding August 13, 2020

            Details:

            Funding will provide further financial support to Bone Therapeutics, in addition to recent financing, to advance its current pivotal phase III clinical study with the enriched protein solution, JTA-004.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 10, 2020

            Details:

            Tonix Pharmaceuticals has met its target enrollment of approximately 470 participants in its Phase 3 RELIEF trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg, ahead of schedule.

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            Lead Product(s): Lorecivivint

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 22, 2020

            Details:

            Phase 2a data highlight the disease modifying promise of lorecivivint based on its ability to slow joint space narrowing, while durably improving pain and function over one year.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 21, 2020

            Details:

            A poster to be presented includes pharmacokinetic (PK) analyses of TNX-102 SL that is being developed as a bedtime treatment for fibromyalgia, posttraumatic stress disorder (PTSD), agitation in Alzheimer’s disease (ADD) and alcohol use disorder (AUD).

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            Lead Product(s): Hyaluronic Acid,Plasma proteins,Fast-acting analgesic

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 18, 2020

            Details:

            The JTA-004 phase III study is a controlled, randomized, double-blind trial that will evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee compared to placebo or Hylan G-F 20.

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            Lead Product(s): Cyclobenzaprine Hydrochloride

            Therapeutic Area: Musculoskeletal Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 24, 2020

            Details:

            50 percent of the planned total number of participants have been randomized in the Phase 3 RELIEF trial evaluating TNX-102 SL for the management of fibromyalgia.

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