fenoprofen

Trade name: nalfon

Small moleculeapproved

Approved

Mar 16, 1976

Fenoprofen is a propionic acid derivative with analgesic, antiinflammatory and antipyretic properties. Fenoprofen inhibits prostaglandin synthesis by decreasing the enzyme needed for biosynthesis. In patients with rheumatoid arthritis, the anti-inflammatory action of fenoprofen has been evidenced by relief of pain, increase in grip strength, and reductions in joint swelling, duration of morning stiffness, and disease activity (as assessed by both the investigator and the patient). In patients with osteoarthritis, the anti-inflammatory and analgesic effects of fenoprofen have been demonstrated by reduction in tenderness as a response to pressure and reductions in night pain, stiffness, swelling, and overall disease activity (as assessed by both the patient and the investigator). These effects have also been demonstrated by relief of pain with motion and at rest and increased range of motion in involved joints. In patients with rheumatoid arthritis and osteoarthritis, clinical studies have shown fenoprofen to be comparable to aspirin in controlling the aforementioned measures of disease activity, but mild gastrointestinal reactions (nausea, dyspepsia) and tinnitus occurred less frequently in patients treated with fenoprofen than in aspirin-treated patients. It is not known whether fenoprofen causes less peptic ulceration than does aspirin. In patients with pain, the analgesic action of fenoprofen has produced a reduction in pain intensity, an increase in pain relief, improvement in total analgesia scores, and a sustained analgesic effect. Indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Also for the relief of mild to moderate pain. — NCATS

Clinical trial activity

0 trials · 0 clinical orgs · 19 marketing orgs

Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0

Timeline

1970s

  1. Mar 16, 1976

    Xspire Pharma — Earliest FDA Approval

  2. Mar 16, 1976

    Xspire Pharma — NDA Secondary Org

  3. Mar 16, 1976

    Xspire Pharma — NDA Organization

  4. Mar 16, 1976

    KEY THERAP — Marketing Organization

  5. Jun 9, 1977

    Eli Lilly — NDA Secondary Org

1980s

  1. Apr 20, 1988

    DAVA Pharmaceuticals — Marketing Organization

  2. May 2, 1988

    Actavis — Marketing Organization

  3. May 2, 1988

    Ani Pharmaceuticals — Marketing Organization

  4. Jun 8, 1988

    Xspire Pharma — Marketing Organization

  5. Jun 13, 1988

    Teva — Marketing Organization

  6. Jul 19, 1988

    Par Pharmaceuticals — Marketing Organization

  7. Jul 19, 1988

    Strides Pharma Science — Marketing Organization

  8. Aug 26, 1988

    Quantum Pharmaceutical — Marketing Organization

  9. Oct 11, 1988

    Watson Pharmaceuticals — Marketing Organization

  10. Oct 14, 1988

    Aurobindo Pharma — Marketing Organization

  11. Oct 14, 1988

    Rising Pharmaceuticals — Marketing Organization

1990s

  1. Dec 21, 1990

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. May 16, 2023

    Misemer Pharmaceutical — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedPriority reviewMar 16, 1976

Chemistry & pharmacology

Loading structure…

SMILES

CC(C(=O)O)c1cccc(Oc2ccccc2)c1
Mol. weight
242.27 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • (+-)-2-(3-phenoxyphenyl)propionic acid
  • (+-)-2-(3-phenoxyphenyl)propionic acid
  • 2-(3-phenoxyphenyl)propionic acid
  • 2-(3-phenoxyphenyl)propionic acid
  • 2-(m-phenoxyphenyl)propionic acid
  • 2-(m-phenoxyphenyl)propionic acid
  • 3-phenoxyhydratropic acid
  • 3-phenoxyhydratropic acid
  • 3-phenoxyhydratropic acid
  • 53858
  • 69323
  • alpha-methyl-3-phenoxybenzeneacetic acid
  • alpha-methyl-3-phenoxybenzeneacetic acid
  • alpha-(m-phenoxyphenyl)propionic acid
  • alpha-(m-phenoxyphenyl)propionic acid
  • dl-2-(3-phenoxyphenyl)propionic acid
  • dl-2-(3-phenoxyphenyl)propionic acid
  • fenoprofen
  • fenoprofen
  • fenoprofen
  • fenoprofen
  • fenoprofen
  • fenoprofen
  • fenoprofen
  • fenoprofen
  • fenoprofen
  • (+/-)-fenoprofen
  • (+/-)-fenoprofen
  • (+/-)-fenoprofen
  • fenoprofen calcium
  • fenoprofen calcium
  • fenoprofen calcium
  • fenoprofen calcium
  • fenoprofen calcium salt
  • fenoprofen calcium salt dihydrate
  • fénoprofène
  • fénoprofène
  • fenoprofeno
  • fenoprofeno
  • fenoprofenum
  • fenoprofenum
  • (+/-)-m-phenoxyhydratropic acid
  • (+/-)-m-phenoxyhydratropic acid
  • nalfon
  • nalfon
  • nalfon
  • progesic
  • progesic

Organizations

Marketing (23)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGMay 2, 1988
Am TherapFor profitMKTG
Ani PharmaceuticalsFor profitMKTGMay 2, 1988
Ani PharmaceuticalsFor profitSYNMay 2, 1988
Aurobindo PharmaFor profitMKTGOct 14, 1988
DAVA PharmaceuticalsFor profitMKTGApr 20, 1988
Eli LillyFor profitNDA2Jun 9, 1977
HalseyFor profitMKTG
KEY THERAPFor profitMKTGMar 16, 1976
Misemer PharmaceuticalFor profitMKTGMay 16, 2023
Par PharmaceuticalsFor profitMKTGJul 19, 1988
Quantum PharmaceuticalFor profitMKTGAug 26, 1988
Rising PharmaceuticalsFor profitMKTGOct 14, 1988
Strides Pharma ScienceFor profitMKTGJul 19, 1988
Sun PharmaceuticalsFor profitMKTGDec 21, 1990
TevaFor profitSYNAug 29, 1988
TevaFor profitMKTGJun 13, 1988
Upsher-Smith LaboratoriesFor profitMKTG
Warner ChilcottFor profitMKTG
Watson PharmaceuticalsFor profitMKTGOct 11, 1988
Xspire PharmaFor profitNDA2Mar 16, 1976
Xspire PharmaFor profitNDAMar 16, 1976
Xspire PharmaFor profitMKTGJun 8, 1988