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Details:
QVM149 combines the bronchodilation of indacaterol acetate (a LABA) and the antimuscarinic effects of glycopyrronium bromide (a LAMA) with mometasone furoate in a precise once-daily formulation, delivered via the dose-confirming Breezhaler® device.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
Iran Expo
Not Confirmed
Contact SupplierDetails:
Vilfuro-G (vilanterol, fluticasone furoate & glycopyrronium bromide) is world's first fixed-dose triple combination drug which is approved for the treatment of chronic obstructive pulmonary disease (COPD).
Lead Product(s): Vilanterol Trifenatate,Fluticasone Furoate,Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Vilfuro-G
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 23, 2023
Details:
A fixed dose combination of vilanterol (adrenergic receptor beta-2 agonist), glycopyrrolate & fluticasone furoate is approved for the treatment of chronic obstructive pulmonary disease.
Lead Product(s): Vilanterol Trifenatate,Glycopyrronium Bromide,Fluticasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
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, 2023
Details:
PREVDUO (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe, the first and only FDA-approved neostigmine–glycopyrrolate combination product in the U.S for Neuromuscular blockade.
Lead Product(s): Neostigmine Methylsulfate,Glycopyrronium Bromide
Therapeutic Area: Neurology Product Name: Prevduo
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 12, 2023
Details:
Glycopyrrolate is an anticholinergic agents, competitively inhibit binding of the neurotransmitter, acetylcholine. Thus, it diminishes the volume and free acidity of gastric secretions and controls excessive pharyngeal, tracheal, and bronchial secretions.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Gastroenterology Product Name: Glycopyrrolate-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2023
Details:
Glycopyrrolate injection is used as a pre-operative medication to inhibit salivary gland and respiratory secretions also as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Neurology Product Name: Glycopyrrolate-Generic
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 01, 2022
Details:
Glycopyrrolate Injection, USP 0.6 mg per 3 mL Simplist prefilled syringe may be administered prior to or concomitantly with Simplist Neostigmine Methylsulfate Injection, USP 3 mg per 3 mL prefilled syringe for reversal of neuromuscular blockade.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Neurology Product Name: Glycopyrrolate-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Details:
A recently completed Phase I clinical trial of the propellant HFO-1234ze in a pMDI containing budesonide, glycopyrronium, formoterol fumarate in healthy adults was positive, demonstrating similar safety and tolerability profile.
Lead Product(s): Budesonide,Glycopyrronium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breztri Aerosphere
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership February 22, 2022
Details:
Covis has entered into an Exclusive Promotion and Distribution Agreement with Novartis Pharmaceuticals Canada, whereby Covis has been appointed as Novartis’ exclusive partner to promote and distribute PrSeebri® Breezhaler® and PrUltibro® Breezhaler® in Canada.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Seebri Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 05, 2022
Details:
First generic version of Merz's CUVPOSA® is Glycopyrrolate (Glycopyrrolate oral solution) launched and shipped in US after approval from ANDA is used to reverse Neuromuscular Block and to reduce saliva production prior to Surgery.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Neurology Product Name: Glycopyrrolate-Generic
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 04, 2022
Details:
Glycopyrrolate injection can also be used in adults as an adjunctive therapy for the treatment of gastrointestinal ulcer when rapid effect is desired or when oral medication is not tolerated.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Gastroenterology Product Name: Glycopyrrolate-Generic
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 10, 2021
Details:
New post hoc analysis results from the phase III IRIDIUM study that suggests that using Enerzair Breezhaler as a step-up therapy from medium-dose LABA/ICS provides benefit beyond increasing ICS dose alone.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2021
Details:
Both companies signed a commercial supply agreement, for a novel formulation of glycopyrrolate (Dartisla) using Catalent’s proprietary Zydis® orally disintegrating tablet delivery technology intended for use as adjunctive therapy in the treatment of patients with peptic ulcer.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Gastroenterology Product Name: Dartisla
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Edenbridge Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 10, 2021
Details:
The preclinical results of PT001 in this indication have been very encouraging. The development of this new therapy will directly improve the standard of care for PAH patients by reducing morbidity and enhancing the quality of life at a reasonable cost.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Cardiology/Vascular Diseases Product Name: PT001
Highest Development Status: PreclinicalProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2021
Details:
European Commission has granted the marketing authorization for Trimbow inhalation powder delivered through NEXThaler (beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium) for treatment of moderate to severe COPD.
Lead Product(s): Beclomethasone Dipropionate,Formoterol Fumarate,Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trimbow
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 21, 2021
Details:
The research, done in collaboration with St Vincent’s Institute of Medical Research in Australia and funded by JDRF and the JDRF T1D Fund, showed that PT001 treatment delayed the onset of hyperglycemia in a mouse model of Type 1 diabetes.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Immunology Product Name: PT001
Highest Development Status: PreclinicalProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021
Details:
Trimbow is the first extrafine formulation fixed triple combination therapy in a single inhaler to be approved for use in appropriate asthma patients. This follows the 2017 approval of this therapeutic option for the treatment of appropriate moderate to severe COPD patients.
Lead Product(s): Beclomethasone Dipropionate,Formoterol Fumarate,Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trimbow
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 01, 2021
Details:
The approval by the European Commission was based on positive results from the ETHOS Phase III trial in which Trixeo Aerosphere, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies 52 weeks.
Lead Product(s): Formoterol Fumarate,Glycopyrronium Bromide,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trixeo Aerosphere
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2020
Details:
Pandion utilizes its TALON (Therapeutic Autoimmune reguLatOry proteiN) drug design and discovery platform to create antibody-based candidates that target known control nodes in the immune system.
Lead Product(s): Glycopyrronium Bromide
Therapeutic Area: Immunology Product Name: PT001
Highest Development Status: PreclinicalProduct Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
Trixeo Aerosphere, a triple-combination therapy, is approved under the brand name Breztri Aerosphere in Japan, China and the US for patients with COPD. Recommendation of triple-combination therapy based on positive results from ETHOS and KRONOS Phase III trials.
Lead Product(s): Budensonide,Glycopyrronium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Trixeo Aerosphere
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 19, 2020
Details:
The administration of the two drugs Formoterol fumarate (LABA) + Glycopyrrolate (LAMA) in a single inhalation will improve outcomes due to the desired synergistic effect of the two drugs and a better adherence to the treatment.
Lead Product(s): Formoterol Fumarate,Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Forglyn
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 08, 2020
Details:
High-dose, once-daily Enerzair® Breezhaler® [IND/GLY/MF] reduced asthma exacerbation rates by 21% (moderate or severe) and 31% (severe) versus medium-dose, over 52 weeks.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2020
Details:
Patients using Enerzair® and Atectura® Breezhaler® to manage their uncontrolled asthma in Japan will have the option to enroll in Propeller’s digital health platform to help manage their condition.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 26, 2020
Details:
The UK pharma giant has received approval for its Breztri Aerosphere, formerly dubbed PT010, culminating the drug’s bumpy regulatory journey in a win. Now, AstraZeneca can challenge the leader in the area — GlaxoSmithKline’s Trelegy — without obstacle.
Lead Product(s): Budensonide,Glycopyrronium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breztri Aerosphere
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 24, 2020
Details:
European Commission approves once-daily Enerzair® Breezhaler® in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with LABA/ICS1.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
Details:
For the first time in Japan, a new digital device combining a sensor with the Breezhaler® inhaler is being made available. Announcement by Novartis Pharma K. K. highlights key milestone for once-daily Enerzair® (IND/GLY/MF) complete with new sensor-enabled Breezhaler® device.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
Details:
Results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy Breztri Aerosphere demonstrated a statistically significant reduction in moderate or severe exacerbations compared with 2 dual-combination therapies in moderate to very severe COPD.
Lead Product(s): Budensonide,Glycopyrronium Bromide,Formoterol Fumarate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Breztri Aerosphere
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 24, 2020
Details:
Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily Tio in improving quality of life in people with uncontrolled asthma.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 05, 2020
Details:
Approval by the NMPA was based on positive results from the Phase III PINNACLE 4 trial1 in which Bevespi Aerosphere demonstrated a statistically significant improvement in lung function as compared to its monotherapy components and placebo.
Lead Product(s): Formoterol Fumarate,Glycopyrronium Bromide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
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 18, 2020
Details:
AIRZ-FF is India's first Glycopyrronium + Formoterol + Fluticasone combination, exclusively studied in the Indian population.
Lead Product(s): Formoterol Fumarate,Glycopyrronium Bromide,Fluticasone Propionate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
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 11, 2020
Details:
Decision supported by robust efficacy and safety data from Phase III IRIDIUM study, in which once-daily Enerzair® Breezhaler® resulted in statistically significant improvements in lung function.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Propeller Health
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 01, 2020
Details:
If the EC follows this recommendation and approves Enerzair® Breezhaler®, it will become the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination for uncontrolled asthma patients.
Lead Product(s): Indacaterol Acetate,Glycopyrronium Bromide,Mometasone Furoate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Enerzair Breezhaler
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 01, 2020
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