Sudafed
(Pseudoephedrine)ApprovedSmall molecule
Pseudoephedrine is used to relieve nasal congestion and sinus pressure caused by colds, allergies, or sinus infections. It works by narrowing blood vessels in the nasal passages to reduce swelling and help you breathe more easily.[2] Sudafed is currently approved and in use across 8 indications[4].[1]
Sudafed is one of 63 small molecule programs targeting Allergic Disease. It is currently in Approved.
8
Indications
20
Total Trials
0
Active Trials
62
Competitors
4
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
23 competitors in Allergic Disease
#DrugCompanyPhaseTrials
1Sudafed
KKenvue Brands
Approved
Taxol
TevaApproved
Decadron
AAspen Global Incorporated
Approved
Proair HFA
GGlaxo Dba Glaxosmithkline
Approved
Rayos
RRoxane Laboratories
Approved
Pulmicort
SSalix
Approved
Bridion
CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Approved
Benadryl
PParkedale
Approved
Adrenaline
SSamson Clinical Operations Pty Ltd
Approved
Taxotere
AAvyxa
Approved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Clinical
Trials by Indication[1]
Allergic Rhinitis3 trials
An Efficacy Study of JNJ-39220675 and Pseudoephedrine in Participants With Allergic Rhinitis
Completed·
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00804687·53 enrolled
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00804687·53 enrolled
Seasonal Allergic Rhinitis3 trials
Medication1 trial
11 more indications
Blood Pressure1 trial
Hyperbaric Oxygen Therapy1 trial
Nasal congestion1 trial
To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses
Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·Phase 4·NCT00648973·1,021 enrolled
MPA1 trial
Blood Pressure Monitoring1 trial
Unspecified1 trial
TransMEM Gas Exchange -- Project 1, Aim 2
Completed·—·Phase 1·NCT01925729·84 enrolled
Regulatory
FDA Approval Timeline[5]
Jan 1, 1982
NOVAFED
NDA NDA017603
Jan 1, 1982
SUDAFED 12 HOUR
NDA NDA017941
Jan 1, 1982
AFRINOL
NDA NDA018191
Dec 15, 1992
SUDAFED 24 HOUR
NDA NDA020021
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Sudafed drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Pseudoephedrine. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Norepinephrine Transporter Releasing Agent[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- KKenvue Brands