This section highlights FDA-related milestones and regulatory updates for drugs developed by AptarGroup (ATR).
Over the past two years, AptarGroup has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
INNA‑051 and SmartTrack™. 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.
INNA‑051 FDA Regulatory Events
INNA‑051 is a drug developed by AptarGroup for the following indication: symptomatic viral respiratory infections.
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:
- INNA‑051
- Announced Date:
- March 19, 2026
- Indication:
- symptomatic viral respiratory infections.
Announcement
AptarGroup, Inc. announced that its Unidose (UDS) Powder Nasal Spray System is being utilized in ENA Respiratory's Phase II clinical study of INNA 051, an investigational nasal spray being evaluated for its potential to help protect against symptomatic viral respiratory infections.
AI Summary
AptarGroup announced that its Unidose (UDS) Powder Nasal Spray System is being used in ENA Respiratory’s Phase II clinical study of INNA 051, an investigational nasal spray being evaluated for its potential to help protect against symptomatic viral respiratory infections. The program is described as a next‑generation, virus‑agnostic approach, meaning it aims to work against a range of respiratory viruses rather than a single pathogen.
The UDS Powder system provides a single‑dose, preservative‑free delivery format for dry‑powder nasal formulations. Aptar says the device supports consistent, unitized dosing and is suitable for clinical development and potential broader use if the therapy proves effective, helping simplify handling and administration.
Pairing ENA Respiratory’s INNA 051 candidate with Aptar’s UDS device helps advance the spray through midstage testing and represents a commercial validation of the delivery technology as the Phase II study proceeds.
Read Announcement
SmartTrack™ FDA Regulatory Events
SmartTrack™ is a drug developed by AptarGroup for the following indication: In-Vitro-in-Silico Platform for Pressurized Metered-Dose Inhalers.
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:
- SmartTrack™
- Announced Date:
- April 16, 2025
- Indication:
- In-Vitro-in-Silico Platform for Pressurized Metered-Dose Inhalers
Announcement
AptarGroup, Inc. announces the commencement of a clinical study to validate its proprietary SmartTrack™ platform.
AI Summary
AptarGroup, Inc. has announced the start of a clinical study to validate its SmartTrack™ platform, developed by its drug services company, Nanopharm. This study aims to show that SmartTrack™ can accurately predict clinical outcomes, potentially reducing the need for full clinical studies during the approval of generic drug products. The platform could serve as an in-vitro-in-silico alternative to traditional comparative clinical endpoint studies, addressing a key challenge for pharmaceutical companies and regulators.
Starting in Q2 2025, the study will involve radio-labelling three commercially available pressurized metered-dose inhaler products to image regional lung deposition. These results will then be compared with predictions from computer simulations and pharmacokinetic data. If validated, SmartTrack™ could accelerate the approval process and broaden patient access to generic medicines.
Read Announcement
