Aquestive Therapeutics
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2004-01-15
- Employees
- 135
- Market Cap
- $421.6M
- Website
- http://www.aquestive.com
- Introduction
Aquestive Therapeutics, Inc. engages in the identifying, developing, and commercializing differentiated products to address unmet medical needs and to solve patients’ therapeutic problems. Its product pipeline include Libervant, AQST-108, AQST-305, Suboxone and Zuplenz. The company was founded in January 2004 and is headquartered in Warren, NJ.
Clinical Trials
8
Trial Phases
3 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
Distribution across different clinical trial phases (8 trials with phase data)• Click on a phase to view related trials
Pharmacokinetics Study of DESF in Adults with Oral Allergy Syndrome
- First Posted Date
- 2024-07-30
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- Aquestive Therapeutics
- Target Recruit Count
- 36
- Registration Number
- NCT06527937
- Locations
- 🇺🇸
Frontage Clinical Services, Inc., Secaucus, New Jersey, United States
Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study
- Conditions
- Epilepsy
- Interventions
- First Posted Date
- 2019-05-17
- Last Posted Date
- 2020-08-18
- Lead Sponsor
- Aquestive Therapeutics
- Target Recruit Count
- 31
- Registration Number
- NCT03953820
- Locations
- 🇺🇸
Clinical Trials of Florida, LLC, Miami, Florida, United States
🇺🇸Bioclinica Research, Orlando, Florida, United States
🇺🇸Florida Premier Research Institute, LLC, Winter Park, Florida, United States
Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS)
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- First Posted Date
- 2018-09-21
- Last Posted Date
- 2020-08-18
- Lead Sponsor
- Aquestive Therapeutics
- Target Recruit Count
- 9
- Registration Number
- NCT03679975
- Locations
- 🇺🇸
University of Florida Center for Movement Disorders & Neuroscience, Gainesville, Florida, United States
Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis
- First Posted Date
- 2018-03-08
- Last Posted Date
- 2019-05-13
- Lead Sponsor
- Aquestive Therapeutics
- Registration Number
- NCT03457753
- Locations
- 🇺🇸
Texas Neurology, P.A., Dallas, Texas, United States
Safety and Tolerability Study of Diazepam Buccal Film (DBF) in Subjects With Epilepsy
- Conditions
- Epilepsy
- Interventions
- First Posted Date
- 2018-02-09
- Last Posted Date
- 2021-08-05
- Lead Sponsor
- Aquestive Therapeutics
- Target Recruit Count
- 149
- Registration Number
- NCT03428360
- Locations
- 🇺🇸
Hawaii Neuroscience Center, Honolulu, Hawaii, United States
🇺🇸Consultants in Epilepsy and Neurology, PLLC, Boise, Idaho, United States
🇺🇸Clinical Research Center of New Jersey (CRCNJ), Voorhees, New Jersey, United States
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News
Aquestive Therapeutics Receives FDA Approval for Anaphylm New Drug Application, Targeting $2 Billion Severe Allergic Reaction Market
The U.S. Food and Drug Administration has approved Aquestive Therapeutics' New Drug Application for Anaphylm, a sublingual epinephrine product for treating severe allergic reactions.
Anaphylm Shows Consistent Efficacy Despite Oral Allergy Syndrome Complications
Phase 2 trial demonstrates that Anaphylm maintains its pharmacokinetic and pharmacodynamic profiles in patients with Oral Allergy Syndrome, showing comparable or superior effectiveness to intramuscular epinephrine.
Aquestive Therapeutics Advances Anaphylm NDA Submission and Alopecia Areata Trial
Aquestive Therapeutics is on track to submit its NDA for Anaphylm sublingual film in Q1 2025, aiming to provide the first orally delivered epinephrine for severe allergic reactions.
Aquestive and Insignis Advance Needle-Free Epinephrine Options for Anaphylaxis Treatment
Aquestive Therapeutics' Anaphylm sublingual film receives positive FDA feedback, reaffirming the NDA submission guidance for Q1 2025, potentially becoming the first orally delivered epinephrine product.
Aquestive Therapeutics Advances Anaphylm and AQST-108, Reports Q3 2024 Financial Results
Aquestive Therapeutics plans to submit Anaphylm™ (epinephrine) Sublingual Film for FDA approval after completing adult supportive studies, with a pre-NDA meeting scheduled for Q4 2024.
Aquestive's Epinephrine Film Demonstrates Rapid Relief for Oral Allergy Syndrome
Aquestive Therapeutics' Anaphylm, a sublingual epinephrine film, shows symptom relief for oral allergy syndrome (OAS) within two minutes.
Aquestive's Anaphylm Shows Rapid Symptom Resolution in Oral Allergy Syndrome Study
Aquestive Therapeutics' Anaphylm sublingual film met both primary and secondary endpoints in an Oral Allergy Syndrome (OAS) challenge study.
Aquestive's Anaphylm Sublingual Film Shows Rapid Symptom Resolution in Allergy Challenge Study
Aquestive Therapeutics' Anaphylm sublingual film demonstrated rapid resolution of allergen-related symptoms, beginning within 2 minutes of administration in an Oral Allergy Syndrome (OAS) challenge study.
Aquestive's Sublingual Epinephrine Film, Anaphylm, Nears NDA Submission for Anaphylaxis Treatment
Aquestive Therapeutics anticipates submitting a New Drug Application (NDA) for Anaphylm, a sublingual epinephrine film, to the FDA in the first quarter of 2025.
Aquestive Therapeutics Advances Anaphylm and Alopecia Treatment, Receives Analyst Boost
Aquestive Therapeutics' Anaphylm sublingual film demonstrated rapid symptom resolution in an oral allergy syndrome challenge study, with a median time of 12 minutes.