Ibuprofen Lysine

For an asymptomatic PDA. Sold as Neoprofen. Every FDA application for this active ingredient: 1 branded and 1 generic.

As of Nov 15, 2026, FDA lists 2 applications for Ibuprofen Lysine (sold as Neoprofen), first approved Apr 13, 2006, with 0 new uses approved and 0 published complete response letters.

First approved: Apr 13, 2006
Applications: 2
New uses approved: 0
Complete response letters: 0

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of patent ductus arteriosusLundbeck, Inc. · designated Oct 29, 1996 · approved Apr 13, 2006

Clinical Trials

144 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effects of Hypoxia or Caffeine on 4km Time-trial Morning Cycling.Caffeine, Hypoxia · Liverpool John Moores University	Phase 4	Recruiting	Nov 13, 2026
Physical Therapy for the Management of Postoperative Pain After Minimally Invasive Thoracic SurgeryPost Operative Pain · University of Miami	Phase 4	Not yet recruiting	Nov 12, 2026
Effect of S-Ibuprofen Gel on Pain in Acute Soft Tissue ContusionsAcute Pain Due to Trauma · Aponia Laboratories, Inc.	Phase 3	Recruiting	Nov 12, 2026
Pollution, Isotonic Nasal Wash, NSAID EvaluationThis Study Will Evaluate the Effects of Woodsmoke Exposures and Advil in Healthy Adults · University of British Columbia	Phase 4	Not yet recruiting	Nov 9, 2026
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot StudyTooth Loss and Rehabillitation, Dental Implant Failure · University of Medicine and Pharmacy at Ho Chi Minh City	Not applicable	Not yet recruiting	Nov 5, 2026
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia RepairInguinal Hernia, Postoperative Pain · Beni-Suef University	Not applicable	Not yet recruiting	Nov 4, 2026
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical ExcisionFibroadenoma, Breast Fibroadenoma · Sohag University	Not applicable	Not yet recruiting	Oct 22, 2026
Comparison of the Effectiveness of Midpoint Transverse Process to Pleura (MTP) Block and Erector Spinae Plane (ESP) Block in Video-Assisted Thoracoscopic Surgery (VATS) at RS NgoerahPain, Postoperative Pain · Udayana University	Not applicable	Recruiting	Oct 9, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 13, 2006	NeoprofenNDA 21903 · New active ingredient	Recordati Rare	9	Marketed
Mar 30, 2016	Ibuprofen LysineANDA 202402	Xgen Pharms	1	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA