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Amitiza

(Lubiprostone)

ApprovedSmall molecule

SSucampo Pharma Americas, LLC

Lubiprostone is a laxative medication that treats chronic constipation, irritable bowel syndrome with constipation in women, and opioid-induced constipation by increasing fluid flow into the bowel to make stools softer and easier to pass.[2] Amitiza is currently approved and in use across 10 indications[4].[1]

Amitiza is one of 280 small molecule programs targeting Non-Alcoholic Fatty Liver Disease. It is currently in Approved.

10

Indications

44

Total Trials

2

Active Trials

279

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

3

Patents

Pipeline

Status by Indication[4][1]

Indication

Non-Alcoholic Fatty Liver DiseaseApproved

Constipation DisorderActive, not recruiting

HIV InfectionApproved

Chronic PainActive, not recruiting

Parkinson DiseaseActive, not recruiting

Multiple SclerosisActive, not recruiting

Cystic FibrosisActive, not recruiting

Slow Transit ConstipationRecruiting

EfficacyTerminated

Non-Alcoholic Fatty Liver DiseaseApproved

Approved

Constipation DisorderApproved

Active, not recruiting

HIV InfectionApproved

Approved

Chronic PainApproved

Active, not recruiting

Parkinson DiseasePreclinical

Active, not recruiting

Multiple SclerosisApproved

Active, not recruiting

Cystic FibrosisPreclinical

Active, not recruiting

Slow Transit ConstipationPhase 3

Recruiting

EfficacyPreclinical

Terminated

Competition

Competitive Landscape

145 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Amitiza

SSucampo Pharma Americas, LLC

Rinvoq

Cytoxan

BBaxter Healthcare Corporation

Questran

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Versed

CConrado Roberto Hoffmann Filho

Zyrtec

Frexalimab

Mayzent

Antihistamine

Arrowhead Pharmaceuticals

MRI Contrast-Enhancing Agents

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

Timeline

Expected Milestones

Q4 2027

Phase 3Recruiting

Slow Transit Constipation

NCT07277907

Q4 2030

Constipation

NCT03720613

Clinical

Trials by Indication[1]

Constipation15 trials

Lubiprostone for the Treatment of Chronic Idiopathic Constipation

Completed· Takeda logo

Takeda·Phase 3·NCT02651155·204 enrolled

Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Terminated·UUniversity of Arkansas·N/A·NCT00669461·1 enrolled

Lubiprostone for Children With Constipation

Completed·SSucampo Pharma Americas, LLC·Phase 3·NCT02138136·419 enrolled

Show 12 more trials

Lubiprostone for Chronic Idiopathic Constipation Treatment

Completed· Takeda logo

Takeda·Phase 3·NCT02729909·211 enrolled

Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation

Completed·SSucampo Pharma Americas, LLC·Phase 4·NCT00452335·127 enrolled

Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation

Completed·MMallinckrodt·Phase 3·NCT01993875·164 enrolled

Evaluation of Clinical Equivalence Between Two Lubiprostone Products in the Treatment of Chronic Idiopathic Constipation

Completed·—·Phase 3·NCT01674530·909 enrolled

Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation

Recruiting·BBioDelivery Sciences International··NCT03720613·34,532 enrolled

Lubiprostone in Children With Functional Constipation

Completed·SSucampo Pharma Americas, LLC·Phase 3·NCT02042183·606 enrolled

Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation

Completed·SShirley Ryan AbilityLab·N/A·NCT00662363·64 enrolled

Evaluation of the Safety of Lubiprostone in Pediatric Participants Aged ≥ 6 Years to < 18 Years With Functional Constipation

Completed·SSucampo Pharma Americas, LLC·Phase 3·NCT02766777·87 enrolled

Lubiprostone for Treatment of Chronic Idiopathic Constipation

Completed· Takeda logo

Takeda·Phase 3·NCT02695719·156 enrolled

Amitiza in Constipation Associated With PD (Parkinson's Disease)

Completed·—·Phase 4·NCT00908076·78 enrolled

Effects of Lubiprostone on Gastric Function in Patients With Chronic Idiopathic Constipation

Completed·—·Phase 4·NCT01460225·19 enrolled

Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications

Terminated·UUniversity of South Alabama·Phase 4·NCT01096290·23 enrolled

Irritable Bowel Syndrome5 trials

Effect of Lubiprostone on Small Bowel Contractions in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS)

Completed·—·N/A·NCT01085643·4 enrolled

Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

Completed·SSucampo Pharma Americas, LLC·Phase 3·NCT00380250·590 enrolled

Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation

Completed·UUniversity of Michigan·N/A·NCT01162863·60 enrolled

Show 2 more trials

Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

Completed·SSucampo Pharma Americas, LLC·Phase 3·NCT00399542·581 enrolled

Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome

Terminated·SSucampo Pharma Americas, LLC·Phase 2·NCT02544152·71 enrolled

Chronic constipation4 trials

Intestinal Microecology in Chronic Constipation

Completed·MMayo Clinic·Phase 1·NCT00934479·21 enrolled

Lubiprostone and Mucus Secretion in Patients With Chronic Constipation

Completed·TTexas Tech University Health Sciences Center, El Paso·Phase 2/3·NCT01447849·40 enrolled

Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation

Completed·TTexas Tech University Health Sciences Center, El Paso·Phase 2/3·NCT01469819·37 enrolled

Show 1 more trial

Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.

Completed·—·Phase 1·NCT01190020·41 enrolled

Function3 trials

Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone

Completed·SSucampo Pharma Americas, LLC·Phase 3·NCT00597428·437 enrolled

Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

Completed·SSucampo Pharma Americas, LLC·Phase 3·NCT00595946·439 enrolled

Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

Completed·SSucampo Pharma Americas, LLC·Phase 3·NCT01298219·439 enrolled

Colonoscopy3 trials

Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy

Completed·—·N/A·NCT00611442·191 enrolled

Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy

Completed·—·Phase 3·NCT01324284·442 enrolled

Amitiza® Plus GoLYTELY® (PEG) Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation

Completed·HHenry Ford Health System·Phase 4·NCT00645801·158 enrolled

13 more indications

Recovery1 trial

Lubiprostone as a Modulator of Gut Microbial Translocation in HIV With Incomplete CD4 Recovery on Antiretroviral Therapy

Completed·RRuth M. Rothstein CORE Center·Phase 2·NCT01839734·20 enrolled

Effectiveness1 trial

The Effectiveness of Lubiprostone in Constipated Diabetics

Completed·EEmory University·Phase 4·NCT01170039·121 enrolled

Cystic Fibrosis1 trial

Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis

Completed·UUniversity of Arkansas·N/A·NCT00706004·9 enrolled

MPA1 trial

Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo

Completed·SSucampo Pharma Americas, LLC·Phase 3·NCT03097861·552 enrolled

Randomized1 trial

Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy

Completed·UUniversity of South Alabama·Phase 4·NCT00746395·45 enrolled

Visceral Pain1 trial

Lubiprostone Effects on Visceral Pain Sensitivity

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT01166789·62 enrolled

SMA1 trial

Effects of Lubiprostone on Small Bowel and Colonic Bacteria: A Correlation Study With Segmental and Whole Gut Transit

Completed·UUniversity of Louisville·Phase 4·NCT00844831·25 enrolled

Safety and Efficacy1 trial

A Safety and Efficacy Evaluation of BLI400 Laxative in Constipated Adults

Completed·BBraintree Laboratories·Phase 3·NCT02481947·459 enrolled

Multiple Sclerosis1 trial

Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

Completed·UUniversity of Rochester·Phase 4·NCT01236534·21 enrolled

Efficacy1 trial

Efficacy of Lubiprostone in Combination With Standard PEG Preparation

Terminated·—·N/A·NCT00689026·60 enrolled

Alcoholic Fatty Liver Disease1 trial

Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease

Completed·HHelwan University·Phase 3·NCT05768334·116 enrolled

Slow Transit Constipation1 trial

Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation: A Multicenter, Randomized Controlled Trial

Recruiting·TThird Military Medical University·Phase 3·NCT07277907·346 enrolled

Unspecified2 trials

Evaluation of Clinical Equivalence Between Two Lubiprostone Products

Completed·AAnchen Pharmaceuticals, Inc·Phase 3·NCT01372423·808 enrolled

Lubiprostone, Colonic Motility and Sensation

Completed·MMayo Clinic·Phase 4·NCT00953043·60 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 29, 2008

AMITIZA

NDA NDA021908

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for Lubiprostone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Amitiza drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lubiprostone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lubiprostone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021908). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Amitiza. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Sucampo Pharma Americas, LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Chloride Channel Protein 2 Opener[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSucampo Pharma Americas, LLC

Patent Landscape[6]

Patent Cliff

Jan 23, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8779187Jan 23, 2027

8338639Jan 23, 2027

8026393Oct 25, 2027

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