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Details:
TFF TAC (tacrolimus) is a next-generation, direct-to-lung, inhaled dry powder formulation of tacrolimus for the treatment and prevention of prophylaxis of organ rejection in lung transplant.
Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: TFF TAC
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 March 25, 2024
Details:
TFF TAC (tacrolimus) is a next-generation, direct-to-lung, inhaled dry powder formulation of tacrolimus for the treatment and prevention of prophylaxis of organ rejection in lung transplant.
Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: TFF-TAC
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 December 19, 2023
Details:
BNSO will develop, manufacture and commercialize a range of innovative ophthalmic pharmaceutical products developed by BioNanoSim, including BNSO-1, a Tacrolimus ocular emulsion developed by its proprietary nano-technology platform to address serious ophthalmic unmet needs.
Lead Product(s): Tacrolimus
Therapeutic Area: Ophthalmology Product Name: BNSO-1
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: BioNanoSim
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 30, 2023
Details:
The collaboration aims to facilitate Chemistry, Manufacturing, and Control documentation for Lipella's drug candidate LP-10 (liposomal tacrolimus), aimed at treating hemorrhagic cystitis. LP-10 has been granted Orphan Drug Designation by the FDA.
Lead Product(s): Tacrolimus
Therapeutic Area: Urology Product Name: LP-10
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Lipella Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 17, 2023
Details:
LP-10 is a proprietary liposomal formulation of tacrolimus that is currently being evaluated as a treatment for moderate to severe hemorrhagic cystitis. The product candidate is currently in Phase 2a clinical trial.
Lead Product(s): Tacrolimus
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: LP-10
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 January 11, 2023
Details:
Study demonstrated that NK cells when stimulated with a cytokine cocktail developed a memory-like phenotype with increased expansion and persistence in vivo, as a treatment for cancer of its m-ceNK platform combined with IL-15 superagonist cytokine fusion protein Anktiva™.
Lead Product(s): Inbakicept,Tacrolimus,Mycophenolate Mofetil
Therapeutic Area: Oncology Product Name: Anktiva
Highest Development Status: Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2022
Details:
The top selling brands are Pangraf (tacrolimus), Alphadol (alfacalcidol), Cilamin (penicillamine) & Livoluk Fibre (lactulose in combination with ispaghula) were ranked number 1, whereas Glizid (Gliclazide + Metformin), Mycept (Mycophenolate Mofetil) were among the top 5.
Lead Product(s): Tacrolimus
Therapeutic Area: Dermatology Product Name: Pangraf
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Panacea Biotec Limited
Deal Size: $251.1 million Upfront Cash: Undisclosed
Deal Type: Agreement February 01, 2022
Details:
Tacrosolv is an improved formulation of tacrolimus, an immunomodulator that can suppress inflammatory reactions, including allergic symptoms. Tacrosolv promises higher bioavailability for local treatment of ocular inflammation.
Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: Tacrosolv
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 April 12, 2021
Details:
The Phase 1 portion of the trial evaluated safety of pacritinib + sirolimus + low-dose tacrolimus after allogeneic hematopoietic cell transplantation. A 3+3 dose escalation design identified PAC 100 mg twice a day was well-tolerated dose for further study.
Lead Product(s): Pacritinib,Sirolimus,Tacrolimus
Therapeutic Area: Immunology Product Name: PAC
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2021
Details:
The ongoing randomized, placebo controlled, crossover, double-blind, single site Phase II clinical trial is testing Tacrosolv, an improved formulation of tacrolimus, in adult subjects who are suffering from grass pollen induced allergic rhinoconjunctivitis.
Lead Product(s): Tacrolimus
Therapeutic Area: Ophthalmology Product Name: Tacrosolv
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 March 11, 2021
Details:
Glenmark has been granted final approval by the U.S. FDA for TacrolimusCapsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf®1 Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US.
Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: Prograf
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 11, 2020
Details:
Abstract titled "Biological and Clinical Impact of JAK2/mTOR Blockade in GVHD Prevention: Preclinical and Phase I Trial Results" will be presented at the 62nd American Society of Hematology Meeting.
Lead Product(s): Pacritinib,Sirolimus,Tacrolimus
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
Company completes dosing of three cohorts with Tacrolimus Inhalation Powder for direct-to-lung delivery of a Thin Film Freezing dry-powder product for prevention of lung transplant rejection.
Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: TFFTAC-LAC
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 October 20, 2020
Details:
Aequus has agreed to an extension of terms for its promotional service agreement with Sandoz Canada Inc. on tacrolimus immediate-release Tacrolimus IR to December 31st, 2021.
Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sandoz B2B
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 16, 2020
Details:
A multi-site, prospective, open-label, dose-escalation clinical trial assessing the safety and efficacy of LP-10 (liposomal tacrolimus) is now open for recruitment at several sites.
Lead Product(s): Tacrolimus
Therapeutic Area: Urology Product Name: LP-10
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 October 15, 2020
Details:
Net proceeds from the financing will be used to accelerate the expansion of the company’s internal development portfolio beyond its programs for Voriconazole and Tacrolimus inhalation powders.
Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: Tac-Lac
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies LLC
Deal Size: $25.9 million Upfront Cash: Undisclosed
Deal Type: Financing August 11, 2020
Details:
The Phase 1 single ascending dose and multiple ascending dose study will assess the safety, tolerability and pharmacokinetics of tacrolimus, an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection.
Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: Undisclosed
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 June 29, 2020
Details:
The Company intends to begin Single Ascending Dose Phase I studies in Tacrolimus Inhalation Powder later this month in Australia, with Multiple Ascending Dose studies.
Lead Product(s): Tacrolimus
Therapeutic Area: Immunology Product Name: TFF TAC-LAC
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 18, 2020
Details:
The study, compares safety and efficacy data of CD24Fc when used in combination with standard of care GVHD prophylaxis compared to placebo and historical controls.
Lead Product(s): MK-7110,Methotrexate,Tacrolimus
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2020
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