Aquestive Therapeutics (AQST) has upcoming FDA regulatory milestones for Anaphylm. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Aquestive Therapeutics (AQST).
Over the past two years, Aquestive Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Anaphylm, epinephrine, and Libervant. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Anaphylm FDA Regulatory Timeline and Events
Anaphylm is a drug developed by Aquestive Therapeutics for the following indication: For epinephrine prodrug candidate product.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Anaphylm
- Announced Date:
- October 15, 2026
- Target Action Date:
- March 16, 2027
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that the Prescription Drug User Fee Act (PDUFA) goal action date set for March 16, 2027
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- October 15, 2026
- Target Action Date:
- Q4 2026
- Estimated Target Date Range:
- October 1, 2026 - December 31, 2026
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that the Ex-U.S. strategy remains on track with Canadian NDS planned for Q4 2026
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- October 15, 2026
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowledged its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis, as complete
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- September 17, 2026
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- August 10, 2026
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced results from its human factors (HF) validation study and pharmacokinetic (PK) study for Anaphylm™ (dibutepinephrine) sublingual film, conducted in support of the Company’s planned resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the treatment of Type 1 allergic reactions, including anaphylaxis.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- March 30, 2026
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced the receipt of preliminary comments and successful completion of an in-person Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the resubmission of the Company's New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type 1 allergic reactions, including anaphylaxis.
AI Summary
Aquestive Therapeutics announced it received preliminary comments and successfully completed an in-person Type A meeting with the U.S. Food and Drug Administration regarding the Company’s planned resubmission of its New Drug Application for Anaphylm™ (dibutepinephrine) sublingual film. Anaphylm is being developed to treat Type 1 allergic reactions, including anaphylaxis.
According to Aquestive, the FDA’s preliminary comments and the direct meeting were constructive and will guide the company’s resubmission work. Aquestive said it will use the feedback to refine its application, address the agency’s questions, and plan next regulatory steps toward potential approval. The company expects to incorporate the FDA input into its filing strategy and will provide updates on timing and follow-up actions as they become available.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- February 20, 2026
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that multiple poster presentations highlighting results from the investigational use of its product candidate Anaphylm™ (dibutepinephrine) sublingual film for the treatment of severe allergic reactions, including anaphylaxis, will be featured at the 2026 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.
AI Summary
Aquestive Therapeutics announced multiple poster presentations at the 2026 AAAAI Annual Meeting showcasing investigational data for Anaphylm™ (dibutepinephrine) sublingual film to treat severe allergic reactions, including anaphylaxis. The results reported that Anaphylm achieved clinically relevant epinephrine plasma concentrations and did not produce a drop in diastolic blood pressure, indicating systemic exposure without that specific hemodynamic concern.
Two posters are in the Anaphylaxis and Venom Allergy session on Sunday, March 1, 9:45–10:45 am: Poster 610, "Epinephrine Plasma Concentration and Hemodynamic Threshold Response Following Sublingual Epinephrine Administration," lead author Matthew Greenhawt, MD, MBA, MSc; and Poster 611, "Novel Sublingual Epinephrine Is Not Associated with a Diastolic Blood Pressure Dip," lead author Gary Slatko, MD.
Abstracts are available online at annualmeeting.acaai.org and on Aquestive’s Scientific Events page in the Investor section. PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- February 2, 2026
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026 for the New Drug Application (NDA) seeking approval of Anaphylm™ (dibutepinephrine) Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more (approximately 66 pounds).
AI Summary
Aquestive Therapeutics announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration on January 30, 2026 for its New Drug Application for Anaphylm™ (dibutepinephrine) Sublingual Film. The NDA sought approval to treat Type I allergic reactions, including anaphylaxis, in patients weighing 30 kg or more (about 66 pounds).
The FDA’s clinical pharmacology review requested a single pharmacokinetics (PK) study to evaluate the impact of proposed packaging and labeling changes. The Agency said the human factors (HF) study and the requested PK study can be conducted in parallel. No additional studies were requested in the CRL.
Aquestive said it believes it has sufficient funding to complete the U.S. approval and pre-launch work while advancing Anaphylm in other key markets. The company scheduled a conference call and webcast for February 2, 2026 to discuss the CRL and next steps.Read Announcement
- Drug:
- Anaphylm
- Announced Date:
- October 30, 2025
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc announced that multiple presentations highlighting results from the investigational use of its product candidate Anaphylm™ (dibutepinephrine) sublingual film in the treatment of severe allergic reactions, including anaphylaxis, will be featured at the 2025 American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting. The meeting will take place November 6-10, 2025, in Orlando, FL..
AI Summary
Aquestive Therapeutics, Inc. announced that it will feature multiple presentations on its investigational Anaphylm™ (dibutepinephrine) sublingual film at the 2025 American College of Allergy, Asthma and Immunology (ACAAI) Annual Meeting. The conference runs November 6–10, 2025, in Orlando, Florida.
On Saturday, November 9, Matthew Greenhawt, MD, MBA, MSc, will deliver an oral presentation titled “Phase 1 Evaluation of Sublingual Film: Pharmacokinetics/Pharmacodynamics Safety Tolerability in at Risk Pediatric Patients” during the Distinguished Industry & Late Breaking Oral Abstracts session.
Additional posters by Nils F. Confer, PhD, include “Sublingual Epinephrine (Anaphylm™) Provides Consistent Pharmacokinetics in both Adult and Pediatric Subjects” on Friday, November 7, and “Recognizing Unmet Needs in Anaphylaxis Care: Insights from Clinician and Caregiver Surveys” on Sunday, November 9.
All abstracts will be available online at annualmeeting.acaai.org and on the Aquestive website’s Scientific Events page beginning November 6, 2025.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- October 8, 2025
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc announced the United States Patent and Trademark Office (USPTO) has issued two additional U.S. patents related to Anaphylm, the Company's novel epinephrine prodrug sublingual film.
AI Summary
On October 8, 2025, Aquestive Therapeutics, Inc. announced the U.S. Patent and Trademark Office has granted two new patents for Anaphylm™, its epinephrine prodrug sublingual film. Patent numbers 12,427,121 and 12,443,850 cover enhanced delivery compositions and feature formulations that facilitate oral mucosal absorption. Each is set to expire on May 4, 2037.
Dan Barber, President and CEO of Aquestive, said these patents extend Anaphylm’s protection through at least 2037. “These claims cover the proprietary composition for Anaphylm, which enables the oral sublingual film delivery of an epinephrine prodrug,” he noted. He emphasized the use of the company’s PharmFilm® and Adrenaverse™ platforms in this approach.
These patents strengthen Aquestive’s intellectual property strategy by adding to a portfolio of pending applications worldwide. They improve barriers against competition as Anaphylm moves forward in development.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- September 4, 2025
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has informed the Company that an advisory committee meeting is not required for Anaphylm™ (dibutepinephrine) Sublingual Film.
AI Summary
Aquestive Therapeutics announced that the U.S. Food and Drug Administration has informed the company it will not hold an advisory committee meeting for Anaphylm™ (dibutepinephrine) Sublingual Film. The New Drug Application remains on track for its PDUFA goal date of January 31, 2026, as the FDA review continues without need for extra advisory input.
Anaphylm is being developed as the first FDA-approved, orally delivered epinephrine product for severe allergic reactions, including anaphylaxis. The sublingual film is similar in size to a postage stamp and dissolves under the tongue without water. If approved, it would offer a needle-free, device-free alternative for people at risk of life-threatening allergic responses.
Commercial planning is underway so that Aquestive can launch Anaphylm rapidly upon approval. The company says it is well positioned to educate healthcare providers, caregivers, and patients about this new option once it clears the FDA.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- June 25, 2025
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc announced that two poster presentations highlighting results from the investigational use of Anaphylm™ (epinephrine) Sublingual Film in the treatment of severe allergic reactions, including anaphylaxis, will be presented at the Center for Food Allergy and Asthma Research (CFAAR) Food Allergy Summit , which will be held June 27-29 in Chicago, Ill.
AI Summary
Aquestive Therapeutics, Inc. announced that two poster presentations will feature data on the investigational use of Anaphylm™ (epinephrine) Sublingual Film for treating severe allergic reactions, including anaphylaxis. These posters will be presented at the Center for Food Allergy and Asthma Research (CFAAR) Food Allergy Summit in Chicago, Illinois, from June 27-29, 2025. Scheduled for June 28 between 5:00 PM and 7:30 PM CST, one poster highlights the film’s physicochemical stability under extreme temperatures, while the other details its rapid and consistent pharmacokinetic and pharmacodynamic responses.
Anaphylm is an innovative, polymer matrix-based epinephrine prodrug designed for easy, water-free administration. If approved by the U.S. Food and Drug Administration, it would become the first and only oral epinephrine option for severe allergic reaction treatment in the United States.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- June 16, 2025
- Target Action Date:
- January 31, 2026
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that FDA assigns PDUFA target action date of January 31, 2026
AI Summary
Aquestive Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for Anaphylm™, a novel treatment for severe allergic reactions such as anaphylaxis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026, meaning it aims to complete its review by that time. This date marks an important milestone as the agency evaluates whether Anaphylm can become an approved, convenient oral option for epinephrine delivery.
If approved, Anaphylm would be the first orally delivered epinephrine treatment available in the United States, potentially replacing bulky, device-based alternatives. Aquestive Therapeutics believes that this innovative approach will help patients manage life-threatening allergic reactions more easily and reliably, fitting smoothly into their everyday lives.
Read Announcement - Drug:
- Anaphylm
- Announced Date:
- June 16, 2025
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for Anaphylm™ in the treatment of Type 1 allergic reactions, including anaphylaxis
AI Summary
Aquestive Therapeutics, Inc. announced that the FDA has accepted its New Drug Application (NDA) for Anaphylm™, a treatment for Type 1 allergic reactions, including anaphylaxis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026, for its review. If approved, Anaphylm will become the first and only orally delivered epinephrine option, offering a groundbreaking, device-free solution for managing severe allergic reactions. Designed to be as thin as a credit card, this innovative product can easily fit in a phone case, wallet, or pocket and does not require special storage conditions. With clinical data showing rapid epinephrine absorption, Anaphylm aims to overcome challenges associated with conventional epinephrine treatments, potentially providing patients with a more accessible and convenient method of administration during allergic emergencies.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- February 12, 2025
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc. announced that multiple presentations highlighting results from the investigational use of Anaphylm epinephrine sublingual film in the treatment of severe allergic reactions, including anaphylaxis, will be featured at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.
AI Summary
Aquestive Therapeutics announced that results from investigational studies using its Anaphylm epinephrine sublingual film to treat severe allergic reactions, including anaphylaxis, will be showcased at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San Diego. The presentations will detail how Anaphylm delivers consistent epinephrine absorption and reliable pharmacokinetic and pharmacodynamic responses. Data from the studies showed that patients experienced a median symptom resolution time of 12 minutes, compared to 74 minutes without treatment, and rapid improvement in angioedema symptoms. Additionally, findings highlighted that Anaphylm maintains its stability and potency under real-world conditions such as extreme temperatures, freezing, and water submersion. These results support Anaphylm’s potential as a portable, non-injectable treatment option for managing life-threatening allergic reactions.
Read Announcement- Drug:
- Anaphylm
- Announced Date:
- December 2, 2024
- Indication:
- For epinephrine prodrug candidate product
Announcement
Aquestive Therapeutics, Inc announced receipt of positive feedback from the U.S. Food and Drug Administration (FDA) prior to its planned NDA submission for Anaphylm™ (epinephrine) Sublingual Film.
AI Summary
Aquestive Therapeutics, Inc. received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its plans for submitting a New Drug Application (NDA) for its Anaphylm™ (epinephrine) Sublingual Film. The FDA agreed with the planned content and format of the NDA submission, noting that no additional adult clinical trials are required before filing. The agency also provided guidance on including extra data views, especially focusing on pharmacokinetic sustainability for a single dose, and suggested minor modifications for the pediatric trial, which the company has already addressed without expecting any delays. Anaphylm, if approved, could be the first and only epinephrine product delivered by a simple sublingual film, offering a potential new treatment option for severe allergic reactions, including anaphylaxis, and presenting a transformative alternative to traditional epinephrine medical devices.
Read Announcement
Epinephrine FDA Regulatory Events
Epinephrine is a drug developed by Aquestive Therapeutics for the following indication: Topical Gel for the treatment of Alopecia areata.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- epinephrine
- Announced Date:
- April 1, 2025
- Indication:
- Topical Gel for the treatment of Alopecia areata
Announcement
Aquestive Therapeutics, Inc released topline results from its pediatric study for Anaphylm (epinephrine) sublingual film in patients aged seven to seventeen and weighing over 30 kgs with a personal history of allergic reactions.
AI Summary
Aquestive Therapeutics, Inc. announced positive topline results from its pediatric study for Anaphylm™ (epinephrine) sublingual film. The study evaluated the treatment in patients aged seven to seventeen who weighed over thirty kilograms and had a personal history of allergic reactions. The data showed that Anaphylm has a consistent pharmacokinetic profile in this group, similar to results seen in adult studies. Moreover, the study demonstrated that the treatment is safe and well-tolerated, with no serious adverse events reported. These positive outcomes are a crucial part of the data being submitted in the New Drug Application (NDA) to the FDA. If the application is accepted—expected in the second quarter of 2025—it could lead to a broader label for pediatric use and contribute to providing a convenient, non-invasive option for patients facing severe allergic reactions.
Read Announcement
Libervant (diazepam) FDA Regulatory Events
Libervant (diazepam) is a drug developed by Aquestive Therapeutics for the following indication: Epileptic seizures.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Libervant (diazepam)
- Announced Date:
- January 13, 2025
- Indication:
- Epileptic seizures
Announcement
Aquestive Therapeutics, Inc provided an update on recent business developments and outlined key objectives for 2025.
AI Summary
Aquestive Therapeutics, Inc. recently updated investors on its latest business developments and shared key objectives for 2025. The company is focused on positioning its innovative pipeline for future success. One major goal is to prepare for the submission of the New Drug Application for its Anaphylm (epinephrine) Sublingual Film in the first quarter of 2025, aiming to address unmet needs in severe allergy management.
Additional objectives include advancing its global development strategy for Anaphylm and initiating a Phase 2a clinical trial for AQST-108 in patients with alopecia areata. Aquestive is also working to increase sales of its Libervant buccal film for pediatric patients and shifting its revenue streams from legacy products to newer growth opportunities. These initiatives reflect the company's commitment to innovative science and improving patient care going forward.
Read Announcement- Drug:
- Libervant (diazepam)
- Announced Date:
- December 19, 2024
- Indication:
- Epileptic seizures
Announcement
Aquestive Therapeutics, Inc. announced the U.S. Food and Drug Administration (FDA) has granted seven years of orphan drug exclusivity (ODE) to Libervant® (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy between two to five years of age.
AI Summary
Aquestive Therapeutics announced that the FDA has granted seven years of orphan drug exclusivity for Libervant® (diazepam) Buccal Film. This designation is for its use in treating intermittent, stereotypic episodes of frequent seizure activity, known as seizure clusters, in pediatric epilepsy patients ages 2 to 5. The exclusivity highlights the FDA’s recognition that the buccal administration of Libervant® offers a significant improvement in ease of use compared to traditional rectal methods. As the first and only orally administered rescue therapy for this age group, Libervant® provides a non-invasive treatment option that can be vital during acute seizure events. This market exclusivity, valid until April 2031, supports further development and access, ensuring that young patients and their caregivers benefit from this innovative and user-friendly treatment option during emergency situations.
Read Announcement
