Wednesday, July 8, 2026

Drug profile · INN

mesalamine

mesalamine (MESALAMINE) is a arachidonate 5-lipoxygenase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: rectal. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 0
Pipeline programs 13
News articles 0
Drug details — mesalamine
US status
approved
Class
Route
RECTAL
Patents
0
Programs
13
Data quality
0.89

Quick answer

mesalamine (MESALAMINE) is a arachidonate 5-lipoxygenase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: rectal. Current US regulatory status: approved.

Key facts

INN mesalamine
Brand MESALAMINE
Mechanism Arachidonate 5-lipoxygenase inhibitor
Target Polyunsaturated fatty acid 5-lipoxygenase
Route RECTAL
Formulation CAPSULE, EXTENDED RELEASE

Mechanism of action

Arachidonate 5-lipoxygenase inhibitor

Primary target: Polyunsaturated fatty acid 5-lipoxygenase

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Asacol® Phase 3 · Tillotts Pharma AG · Active Ulcerative Colitis
  2. MMX Mesalamine/Mesalazine (Low Dose) Phase 3 · Takeda · Ulcerative Colitis
  3. mesalazine (Asacol®) Phase 3 · Cardiff Oncology · Ulcerative Colitis
  4. Pentasa Sachet depotgranulat for Lynch syndrome, which is increa… Phase 2 · George Institute for · Lynch syndrome, which is increasing the risk of developing c
  5. MESAL-02-25 Phase 1 · Anaxis Pharma · ulcerative colitis
  6. MESAL-03-25 Phase 1 · Anaxis Pharma · ulcerative colitis
  7. MESAL-19-24 Phase 1 · Anaxis Pharma · ulcerative colitis
  8. MESAL-20-24 Phase 1 · Anaxis Pharma · ulcerative colitis

Related & competitor drugs

  1. meclofenamate sodium Arachidonate 5-lipoxygenase inhibitor
  2. zileuton Arachidonate 5-lipoxygenase inhibitor
  3. balsalazide disodium Cyclooxygenase inhibitor
  4. olsalazine sodium Arachidonate 5-lipoxygenase inhibitor
  5. sulfasalazine Arachidonate 5-lipoxygenase inhibitor
  6. mesalazine Arachidonate 5-lipoxygenase inhibitor

Frequently asked questions

What is mesalamine?

mesalamine (MESALAMINE) is a arachidonate 5-lipoxygenase inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: rectal. Current US regulatory status: approved.

What is the brand name for mesalamine?

MESALAMINE is a marketed brand name for mesalamine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of mesalamine?

mesalamine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.