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Details:
The agreement aims for the potential launch and commercialization of Tonmya (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets), a centrally acting, non-opioid medication, in the US.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Tonix Pharmaceuticals Holding Corp
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 20, 2024
Details:
Tonmya (cyclobenzaprine HCl) is a sublingual product candidate. It is a multifuntional agent with antagonist activity at serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors. It is being evaluated for the treatment of fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
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 06, 2024
Details:
Tonmya (cyclobenzaprine HCl) is a sublingual product candidate. It is a multifuntional agent with antagonist activity at serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors. It is being evaluated for the treatment of fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
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 26, 2024
Details:
The collaboration aims to support Tonix to focus on the Tonmya (cyclobenzaprine HCl), which is a multifunctional agent with potent binding and antagonist activity at the 5-HT2A-serotonergic. It is in development as a daily bedtime treatment for fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Tonix Pharmaceuticals Holding Corp
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 13, 2024
Details:
Tonmya (TNX-102 SL) is a sublingual tablet formulation of cyclobenzaprine hydrochloride, which is being evaluated for the treatment of acute stress disorder (ASD) and posttraumatic stress disorder (PTSD).
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology Product Name: Tonmya
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 12, 2024
Details:
TNX-102 SL (cyclobenzaprine HCl) is a sublingual product candidate. It is a multifuntional agent with antagonist activity at serotonin2A, α1-adrenergic, histaminergic-H1, and muscarinic-M1 receptors. It is being evaluated in phase 3 clinical trials for the treatment of Fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
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 01, 2024
Details:
Tonix currently intends to use the net proceeds for the preparation of their new drug application relating to TNX-102 SL (cyclobenzaprine hydrochloride) in patients with fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alliance Global Partners
Deal Size: $144.0 million Upfront Cash: $30.0 million
Deal Type: Public Offering December 21, 2023
Details:
Tonmya (cyclobenzaprine HCl) is a 5-HT2 receptor inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of Fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
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 December 20, 2023
Details:
TNX-102 SL (cyclobenzaprine) is a sublingual muscle relaxant which is being evaluated for the treatment & management of fibromyalgia-type long covid.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: Tonmya
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 December 13, 2023
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is investigated for the treatment of management of fibromyalgia-type Long COVID.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
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 15, 2023
Details:
The net proceeds will be used to investigate the potential of Tonix’s TNX-102 SL, a sublingual formulation of cyclobenzaprine HCl, to reduce the frequency and severity of adverse effects of acute trauma.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology Product Name: TNX-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: U.S. Department of Defense
Deal Size: $3.0 million Upfront Cash: Undisclosed
Deal Type: Funding September 27, 2023
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which is investigated for the treatment of management of fibromyalgia-type Long COVID.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
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 05, 2023
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
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 August 07, 2023
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
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 01, 2023
Details:
TNX-102 SL (cyclobenzaprine hydrochloride) is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate which relieves skeletal muscle spasm of local origin without interfering with muscle function.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
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 13, 2023
Details:
TNX-102 SL (cyclobenzaprine hydrochloride) is a small, rapidly-disintegrating, under the tongue (sublingual) product candidate which relieves skeletal muscle spasm of local origin without interfering with muscle function.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
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 22, 2023
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
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 December 19, 2022
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Infections and Infectious Diseases Product Name: TNX-102
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 August 22, 2022
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, did not achieve statistical significance on the primary endpoint (p=0.115) in a subsequent Phase 3 study (RALLY).
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
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 07, 2022
Details:
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Infections and Infectious Diseases Product Name: TNX-102
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 06, 2022
Details:
As expected based on previously reported pre-specified interim analysis results, TNX-102 (cyclobenzaprine HCl ) did not achieve statistical significance on the primary endpoint of reducing fibromyalgia (FM) daily pain at Week 14 compared to placebo in Phase 3 RALLY study.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
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 21, 2022
Details:
TNX-102 SL (cyclobenzaprine HCl sublingual tablets) did not achieve statistical significance on the primary endpoint of reducing fibromyalgia (FM) daily pain at Week 14 compared to placebo (p=0.115) in the Phase 3 RALLY study.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102
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 21, 2022
Details:
TNX-102 SL was well tolerated with the most common adverse event from active treatment being oral hypoaesthesia, a sensory administration site reaction that is typically transient, was never rated as severe, and only lead to one discontinuation.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
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 08, 2021
Details:
The primary endpoint is daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
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 23, 2021
Details:
Tonix is planning a Phase 3 PTSD study of TNX-102 SL in Kenya, expected to initiate in the third quarter of 2021, and will focus on studying police.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology Product Name: TNX-102 SL
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 12, 2020
Details:
Tonix is currently enrolling into a second potentially pivotal Phase 3 trial, F306 or the RALLY study, to study TNX-102 SL for the management of fibromyalgia, with topline data expected in the second half of 2021.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
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 29, 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.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
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 03, 2020
Details:
FDA has cleared the Investigational New Drug (IND) application for the initiation of a Phase 2 proof-of-concept study using TNX-102 SL for treatment of alcohol use disorder (AUD).
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology Product Name: TNX-102 SL
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 06, 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.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal Product Name: TNX-102 SL
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 10, 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).
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal 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 21, 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.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Musculoskeletal 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 24, 2020
Details:
RECOVERY study has stopped enrollment due to inadequate separation from placebo at week-12 based on interim analysis results of the first 50% of enrolled participants.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology 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 February 05, 2020
Details:
Tonix expects the data to satisfy pharmacokinetic requirements for potential New Drug Applications (NDA) for TNX-102 SL for PTSD and Fibromyalgia.
Lead Product(s): Cyclobenzaprine
Therapeutic Area: Psychiatry/Psychology 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 January 24, 2020
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