Lialda

(Mesalamine)

ApprovedSmall molecule

Mesalamine is used to treat ulcerative colitis, an inflammatory bowel condition that causes swelling and sores in the colon and rectum. It works by reducing inflammation in the digestive tract and helps maintain symptom improvement over time.[2] Lialda is currently approved and in use across 13 indications[4].[1]

Lialda is one of 250 small molecule programs targeting Malnutrition. It is currently in Approved.

Indications

Total Trials

Active Trials

249

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

MalnutritionApproved

HyperplasiaUnknown status

HIV InfectionCompleted

ColitisRecruiting

BerylliosisApproved

ProctitisActive, not recruiting

Colorectal AdenomaApproved

Colorectal CancerRecruiting

Crohn's DiseaseApproved

Ulcerative ColitisCompleted

MalnutritionApproved

Approved

HyperplasiaApproved

Unknown status

HIV InfectionApproved

Completed

ColitisPhase 2

Recruiting

BerylliosisApproved

Approved

ProctitisApproved

Active, not recruiting

Colorectal AdenomaApproved

Approved

Colorectal CancerPhase 2

Recruiting

Crohn's DiseaseApproved

Approved

Ulcerative ColitisApproved

Completed

Showing 10 of 13 indications

Competition

Competitive Landscape

254 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Camptosar

Pfizer

Phase 3

34 2

Lialda

Takeda

Approved

2 3

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

8 4

Decadron

AAspen Global Incorporated

Phase 3

7 5

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

4 6

Botensilimab

AAgenus Inc.

Phase 3

9 7

Calcium Folinate

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 3

3 8

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Phase 3

2 9

Adjuvant Chemotherapy

NNizhny Novgorod Regional Clinical Oncology Center

Phase 3

2 10

BL-M07D1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Ulcerative Colitis

NCT06993974

Phase 1Not yet recruiting

Ulcerative Colitis

NCT06525974

Q1 2027

Phase 2Not yet recruiting

Ulcerative Colitis

NCT07349472

Phase 2Recruiting

Ulcerative Colitis

NCT07333716

Q3 2027

Phase 2Recruiting

Colitis

NCT05663775

Q3 2045

Phase 2Recruiting

Colorectal Cancer

NCT04920149

Clinical

Trials by Indication[1]

Ulcerative Colitis21 trials

Pentoxifylline in Patients With Ulcerative Colitis

Not yet recruiting·IIhab Elsayed Hassan·Phase 2·NCT07349472·60 enrolled

Rupatadine in Patients With Ulcerative Colitis

Recruiting·—·Phase 2·NCT07064707·60 enrolled

Desloratadine in Patients With Ulcerative Colitis

Recruiting·TTanta University·Phase 2·NCT07333716·44 enrolled

Show 18 more trials

Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)

Completed·—·Phase 3·NCT02280629·150 enrolled

Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis

Completed·TTanta University·Phase 2·NCT05567068·54 enrolled

Nitazoxanide in Patients With Ulcerative Colitis

Recruiting·—·Phase 2·NCT06993974·70 enrolled

Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis

Completed·WWolfson Medical Center·Phase 4·NCT01201122·86 enrolled

A Double Blind Study for the Treatment of Acute Ulcerative Colitis

Completed·WWarner Chilcott·Phase 3·NCT00350415·772 enrolled

A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis

Withdrawn· AbbVie logo

AbbVie·Phase 3·NCT05316220

Fenofibrate in Ulcerative Colitis

Recruiting·TTanta University·Phase 2/3·NCT05753267·60 enrolled

Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis

Completed·AAltheus Therapeutics, Inc.·Phase 1·NCT01020708·9 enrolled

Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

Completed· Ferring logo

Ferring·Phase 3·NCT02522767·228 enrolled

Microbiota and Probiotic Therapy in Ulcerative Colitis Patients

Completed·TTanta University··NCT07180186·70 enrolled

PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis

Terminated·VVSL Pharmaceuticals·N/A·NCT03415711·14 enrolled

A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis

Completed·EEMET Pharmaceuticals, LLC·Phase 3·NCT01045018

Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis

Active, not recruiting·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT05119140·3 enrolled

Clinical Study to Evaluate the Possible Efficacy and Safety of Febuxostat in Patients With Ulcerative Colitis Treated With Mesalamine

Not yet recruiting·TTanta University·Phase 1·NCT06525974·46 enrolled

Mercaptopurine Therapy in Ulcerative Colitis

Unknown status·—·Phase 3·NCT02910245·136 enrolled

Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

Completed· Ferring logo

Ferring·Phase 3·NCT02522780·276 enrolled

A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.

Terminated·WWarner Chilcott·Phase 1·NCT00254618·34 enrolled

Beneficial Effect of Silymarin in Ulcerative Colitis

Recruiting·TTanta University·Phase 2·NCT06213857·44 enrolled

LAM3 trials

Mesalamine in Environmental Enteropathy

Completed·KKelsey Jones·Phase 1/2·NCT01841099·44 enrolled

Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations

Completed·PPadagis LLC·N/A·NCT00802451·48 enrolled

PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

Completed·BBausch Health Americas, Inc.·Phase 1·NCT00622375·24 enrolled

Inflammatory Bowel Diseases3 trials

Repurposing Fenofibrate in Modulating AMPK/NLRP3 Inflammasome in Patients With Ulcerative Colitis

Completed·TTanta University·Phase 2·NCT05781698·70 enrolled

Clinical Study to Evaluate the Possible Efficacy of Nifuroxazide in Patient With Ulcerative Colitis

Completed·MMostafa Bahaa·Preclinical·NCT05988528·50 enrolled

Clinical Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Ulcerative Colitis

Completed·MMostafa Bahaa·Preclinical·NCT05986136·60 enrolled

Colorectal Cancer2 trials

Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

Recruiting·AAnn-Sofie Backman·Phase 2·NCT04920149·150 enrolled

Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome

Terminated·CChristoph Gasche·Phase 2·NCT03070574·8 enrolled

Irritable Bowel Syndrome2 trials

The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

Completed·UUniversity of Utah·Phase 3·NCT01412372·61 enrolled

Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)

Completed·UUniversity of Florida·Phase 2·NCT01327300·7 enrolled

16 more indications

Diverticulitis2 trials

Asacol Acute Diverticulitis(DIVA)Study

Completed·WWarner Chilcott·Phase 2·NCT00554099·117 enrolled

Evaluation of Efficacy of Mesalamine in the Long-term Prevention of Diverticulitis Flares

Completed·SSOFAR S.p.A.·Phase 3·NCT01120340·105 enrolled

Adult Subject1 trial

Taste Assessment Study of SHP429 in Healthy Adult Subjects

Completed· Takeda logo

Takeda·Phase 1·NCT02125292·18 enrolled

Colitis1 trial

Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)

Recruiting·AAHS Cancer Control Alberta·Phase 2·NCT05663775·20 enrolled

Hermansky-Pudlak syndrome1 trial

Medical Treatment of Colitis in Patients With Hermansky-Pudlak Syndrome

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00514982

Oxidative Stress1 trial

Targeting Oxidative Stress in Chronic Beryllium Disease

Completed·NNational Jewish Health·Phase 1/2·NCT01088243·18 enrolled

Recurrence1 trial

Cimzia Versus Mesalamine for Crohn's Recurrence

Terminated·MMilton S. Hershey Medical Center·Phase 4·NCT01696942·10 enrolled

Remission1 trial

Dose Escalation and Remission (DEAR)

Completed·JJames Lewis·Phase 4·NCT00652145·119 enrolled

Hyperplasia1 trial

Clinical Management of Childhood Intestinal Lymphoid Nodular Hyperplasia

Unknown status·AAzienda Policlinico Umberto I·Phase 4·NCT01789294·270 enrolled

Clinical Trial1 trial

Clinical Trial With Mesalamine 1g Suppositories

Terminated· Novartis logo

Novartis·Phase 3·NCT01172444·158 enrolled

Lymphocytic Colitis1 trial

Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Completed·—·Phase 3·NCT01209208·57 enrolled

Microscopic Colitis1 trial

Trial of Mesalamine for the Treatment of Active Microscopic Colitis

Completed·MMayo Clinic·Phase 2/3·NCT00952952·70 enrolled

HIV infection1 trial

Mesalamine to Reduce T Cell Activation in HIV Infection

Completed·UUniversity of California, San Francisco·Phase 4·NCT01090102·33 enrolled

Eosinophilic Esophagitis1 trial

Mesalazine Oral Suspension in Active Eosinophilic Esophagitis

Completed·—·Phase 2·NCT05488405·5 enrolled

MPA1 trial

A Comparison of Once a Day Dose Compared to 2 Doses/Day

Completed·WWarner Chilcott·Phase 3·NCT00505778·1,027 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)

Completed·WWarner Chilcott·Phase 3·NCT00577473·301 enrolled

Diverticular Disease1 trial

Mesalamine for Uncomplicated Diverticular Disease: a Randomized, Double-blind, Placebo-controlled Study

Completed·—·Phase 2·NCT01627262·123 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 24, 1987

ROWASA

NDA NDA019618

Dec 18, 1990

ROWASA

NDA NDA019919

Jan 31, 1992

ASACOL

NDA NDA019651

May 10, 1993

PENTASA

NDA NDA020049

Nov 5, 2004

CANASA

NDA NDA021252

Jan 16, 2007

LIALDA

NDA NDA022000

Jan 16, 2007

LIALDA

NDA NDA022000

May 29, 2008

ASACOL HD

NDA NDA021830

Oct 31, 2008

APRISO

NDA NDA022301

Oct 30, 2009

LIALDA

NDA NDA022000

Sep 22, 2010

LIALDA

NDA NDA022000

Jul 14, 2011

LIALDA

NDA NDA022000

Feb 1, 2013

DELZICOL

NDA NDA204412

Aug 9, 2013

LIALDA

NDA NDA022000

Aug 9, 2013

LIALDA

NDA NDA022000

Aug 28, 2013

LIALDA

NDA NDA022000

Dec 16, 2013

LIALDA

NDA NDA022000

Mar 14, 2014

LIALDA

NDA NDA022000

Oct 16, 2014

LIALDA

NDA NDA022000

Jul 27, 2017

LIALDA

NDA NDA022000

Aug 22, 2017

LIALDA

NDA NDA022000

May 23, 2018

LIALDA

NDA NDA022000

Jul 18, 2019

LIALDA

NDA NDA022000

Jun 26, 2020

LIALDA

NDA NDA022000

Oct 1, 2020

LIALDA

NDA NDA022000

Dec 17, 2020

LIALDA

NDA NDA022000

May 25, 2021

LIALDA

NDA NDA022000

Nov 1, 2021

LIALDA

NDA NDA022000

Nov 16, 2022

LIALDA

NDA NDA022000

Oct 24, 2023

LIALDA

NDA NDA022000

Oct 14, 2026

LIALDA

NDA NDA022000

Sources

References

[1]
ClinicalTrials.gov — 48 trial records for Mesalamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lialda drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Mesalamine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Mesalamine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022000). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lialda. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Arachidonate 5-Lipoxygenase Inhibitor; Cyclooxygenase Inhibitor; Peroxisome Proliferator-Activated Receptor Gamma Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Takeda

Patent Landscape[6]

Patent Cliff

Jul 24, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7645801Jul 24, 2027

8217083Jun 6, 2028

8436051Jun 6, 2028

8865688May 1, 2030

Lialda

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q3 2045

Trials by Indication[1]

Ulcerative Colitis21 trials

LAM3 trials

Inflammatory Bowel Diseases3 trials

Colorectal Cancer2 trials

Irritable Bowel Syndrome2 trials

Diverticulitis2 trials

Adult Subject1 trial

Colitis1 trial

Hermansky-Pudlak syndrome1 trial

Oxidative Stress1 trial

Recurrence1 trial

Remission1 trial

Hyperplasia1 trial

Clinical Trial1 trial

Lymphocytic Colitis1 trial

Microscopic Colitis1 trial

HIV infection1 trial

Eosinophilic Esophagitis1 trial

MPA1 trial

Safety and Efficacy1 trial

Diverticular Disease1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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