Pulmatrix's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Pulmatrix (PULM).
Over the past two years, Pulmatrix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
uSMITE™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
USMITE™ FDA Regulatory Events
USMITE™ is a drug developed by Pulmatrix for the following indication: Protein Degrader for Acute and Chronic Pain.
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:
- uSMITE™
- Announced Date:
- January 22, 2025
- Indication:
- Protein Degrader for Acute and Chronic Pain
Announcement
Cullgen Inc. announced that it has begun dosing in human subjects to evaluate its potential first-in-class, oral, pan-TRK protein degrader for the treatment of pain.
AI Summary
Cullgen Inc. has started dosing human subjects to evaluate its new pan-TRK protein degrader, CG001419, which is being developed as a potential first-in-class, oral treatment for pain. The investigational small molecule is designed to selectively degrade both mutant and wild-type TRK proteins, aiming to block pain signals without using traditional opioids or NSAIDs. This innovative approach could help reduce the risk of addiction associated with many current pain medications.
The clinical trial, approved by an ethics committee in Australia, is a Phase 1 study involving healthy volunteers. It is a randomized, placebo-controlled, double-blind trial that will look at the safety, tolerability, and how the drug is processed in the body. Cullgen’s study underlines its goal to use its uSMITE™ platform in developing targeted pain therapies and other treatments across multiple medical areas.
Read Announcement
Pulmatrix FDA Events - Frequently Asked Questions
As of now, Pulmatrix (PULM) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Pulmatrix (PULM) has reported FDA regulatory activity for uSMITE™.
The most recent FDA-related event for Pulmatrix occurred on January 22, 2025, involving uSMITE™. The update was categorized as "Dosing Update," with the company reporting: "Cullgen Inc. announced that it has begun dosing in human subjects to evaluate its potential first-in-class, oral, pan-TRK protein degrader for the treatment of pain."
Currently, Pulmatrix has one therapy (uSMITE™) targeting the following condition: Protein Degrader for Acute and Chronic Pain.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:PULM) was last updated on 7/17/2025 by MarketBeat.com Staff
