NCT07486921
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
biotech · Non-Small Cell Lung Cancer · Pneumococcal Vaccines · MAIA
MAIA Biotechnology
Makai Biotechnology is a biotech organization headquartered in honolulu, USA. It trades on NYSE under ticker MAIA. Primary therapeutic focus areas include Non-Small Cell Lung Cancer, Pneumococcal Vaccines, Carcinoma, Non
honolulu, USA HQ
2013 Founded
5 Employees
Public company Type
MAIA · NYSE Ticker
Company details
- Status
- Public
- HQ
- honolulu, USA
- Founded
- 2013
- Employees
- 5
- Programs
- 8
- Drugs
- 19
- Patents
- 10
etrasimod
Phase 2 · small molecule · Pouchitis
Etrasimod is a small-molecule oral therapeutic being developed by MAIA Biotechnology for the treatment of pouchitis, an inflammatory condition affecting patients with a surgically created pouch (ileal pouch-anal anastomosis). The program is currently in Phase 2 development under study code STUDY-25-01158, with the most
Internal code STUDY-25-01158
At a glance
- Sponsor
- MAIA Biotechnology
- Phase
- Phase 2
- Modality
- small_molecule
- Indication
- Pouchitis
- Status
- active
- Trials
- 1
Executive summary
Etrasimod is a small-molecule oral therapeutic being developed by MAIA Biotechnology for the treatment of pouchitis, an inflammatory condition affecting patients with a surgically created pouch (ileal pouch-anal anastomosis). The program is currently in Phase 2 development under study code STUDY-25-01158, with the most recent milestone dated March 23, 2026. The active ingredient, etrasimod arginine, is marketed as VELSIPITY and has already received FDA approval (NDA216956) as a Pfizer-sponsored product, indicating prior regulatory validation of the compound class. MAIA's development strategy appears focused on repurposing or extending the application of this approved agent into the pouchitis indication. The Phase 2 trial (NCT07486921) represents the current clinical progress. Mechanism of action, specific target engagement, and detailed milestone outcomes remain not yet disclosed in available sources.
Why this program matters
Pouchitis represents a significant unmet medical need in gastroenterology, affecting a subset of patients who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis, typically for ulcerative colitis or familial adenomatous polyposis. Current treatment options are limited and often involve antibiotics or immunosuppressive agents with variable efficacy and tolerability concerns. The competitive landscape includes established therapies such as vedolizumab (Takeda), as well as experimental approaches including fecal microbiota transplantation and various antibiotic combinations. An oral small-molecule agent with a favorable safety and efficacy profile could address a meaningful gap in the therapeutic armamentarium for this patient population. The commercial significance is moderate but focused, as pouchitis affects a defined patient population, though the indication represents a specialized gastroenterology market. Regulatory precedent exists through VELSIPITY's prior FDA approval, which may facilitate expedited development pathways if clinical efficacy is demonstrated in the pouchitis population.
Drug intelligence
Drug Class: Small-molecule oral therapeutic
Active Ingredient: Etrasimod arginine
Brand Name: VELSIPITY
Route of Administration: Oral
Modality: Small molecule
Mechanism of Action: Not yet disclosed
Target: Not yet disclosed
Related Therapies: VELSIPITY (etrasimod arginine) has prior FDA approval (NDA216956) under Pfizer sponsorship, indicating established pharmaceutical development and regulatory history for this compound.
Patent Status: Not yet disclosed
pouchitis
Prevalence: Point prevalence: 1-5 / 10 000 (Europe) — source: Orphanet, validated.
Overview
Acute inflammation in the intestinal mucosa of the continent ileal reservoir (or pouch) in patients who have undergone ileostomy and restorative proctocolectomy (proctocolectomy, restorative).
Treatment landscape
ClinicalTrials.gov lists 45 registered studies for Pouchitis (AACT aggregate).
Phase breakdown: NA (16), PHASE2 (10), PHASE3 (6), PHASE4 (5), PHASE1/PHASE2 (3), EARLY_PHASE1 (2), PHASE1 (2), PHASE2/PHASE3 (1)
Common investigational therapies:
- Placebo
- Vedolizumab
- AST-120
- Adalimumab
- Mesenchymal Stem Cells (MSCs)
- Tofacitinib 10 mg
- Liraglutide Pen Injector
- Placebo Pen Injector
- Active FMT, then open label FMT
- Placebo FMT, then open label FMT
Disease data sourced from MONDO Disease Ontology (MONDO:0005312), Orphanet — pouchitis, NCT00061282, NCT00293553, NCT00583076, NCT00583531, NCT01202396, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 22026-03-23
Latest Phase 2 milestone
Most recent disclosed milestone in Phase 2 development; specific outcome not yet disclosed.
Competitive landscape
The pouchitis treatment landscape includes several competing approaches. Vedolizumab (Takeda) is an approved monoclonal antibody therapy also being evaluated in Phase 3 trials for pouchitis. Takeda is also investigating a combination approach including rifaximin, vancomycin, Entyvio (vedolizumab), amoxicillin/clavulanic acid, and ciprofloxacin in Phase 3 development. Lacuna Pharma Pty Ltd is pursuing a Phase 2 program combining metronidazole, fosfomycin, and molgramostim. MAIA Biotechnology itself is exploring fecal microbiota transplantation as a Phase 1 approach. Etrasimod's competitive advantage, if demonstrated, would derive from its oral route of administration and small-molecule profile compared to the intravenous vedolizumab. However, the mechanism of action and specific therapeutic rationale for etrasimod in pouchitis remain undisclosed, limiting assessment of its differentiation versus existing and investigational alternatives.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| Vedolizumab Placebo | Takeda | small_molecule | approved |
| RIFAXIMIN , VANCOMYCIN , Entyvio 300 mg powder for concentrate for solution for infusion, AMOXICILLIN AND BETA-LACTAMASE INHIBITOR , CIPROFLOXACIN , METRONIDAZOLE | Takeda | small_molecule | phase_3 |
| Vedolizumab | Takeda | small_molecule | phase_3 |
| METRONIDAZOLE, FOSFOMYCIN, MOLGRAMOSTIM | Lacuna Pharma Pty Ltd | small_molecule | phase_2 |
| Fecal Microbiota Transplant (FMT) | MAIA Biotechnology | small_molecule | phase_1 |
| USTEKINUMAB | — | Interleukin-23 inhibitor | Phase 3 |
| ALICAFORSEN | — | Intercellular adhesion molecule-1 mRNA 3'UTR antisense inhibitor | Phase 3 |
| TOFACITINIB | — | Janus Kinase (JAK) inhibitor | Phase 2 |
| LIRAGLUTIDE | — | Glucagon-like peptide 1 receptor agonist | Phase 2 |
| SARGRAMOSTIM | — | Granulocyte-macrophage colony-stimulating factor receptor agonist | Phase 1 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
United States (FDA): Etrasimod arginine (VELSIPITY) has received FDA approval under NDA216956 with Pfizer as the listed sponsor. This approval establishes regulatory precedent for the compound. The current Phase 2 program in pouchitis (STUDY-25-01158) represents development in a new indication.
European Medicines Agency (EMA): Regulatory status not yet disclosed.
Pharmaceuticals and Medical Devices Agency (PMDA, Japan): Regulatory status not yet disclosed.
National Medical Products Administration (NMPA, China): Regulatory status not yet disclosed.
Clinical evidence summary
Key questions answered
What is etrasimod used for?
Etrasimod is being developed by MAIA Biotechnology for the treatment of pouchitis, an inflammatory condition affecting patients with a surgically created ileal pouch-anal anastomosis. The compound is currently in Phase 2 clinical development for this indication.
Is etrasimod approved by the FDA?
Etrasimod arginine (VELSIPITY) has received FDA approval under NDA216956 with Pfizer as the sponsor. However, this approval is for an indication other than pouchitis. The pouchitis program is currently in Phase 2 development and is not yet approved for this indication.
What is the mechanism of action of etrasimod?
The mechanism of action of etrasimod has not yet been disclosed in available sources.
Who manufactures etrasimod?
Etrasimod arginine (VELSIPITY) was developed and approved by Pfizer. MAIA Biotechnology is currently developing etrasimod for pouchitis, though the manufacturing and commercialization relationship between MAIA and Pfizer is not yet disclosed.
What is the route of administration for etrasimod?
Etrasimod is administered orally, providing a convenient non-parenteral route compared to intravenous alternatives such as vedolizumab.
What clinical trials are supporting etrasimod development in pouchitis?
The primary disclosed trial is NCT07486921, a Phase 2 study under MAIA Biotechnology's STUDY-25-01158. Specific trial design, endpoints, and results have not yet been disclosed.
What is the current development phase of etrasimod for pouchitis?
Etrasimod is currently in Phase 2 development for pouchitis. The most recent milestone was dated March 23, 2026, though specific outcomes remain undisclosed.
What are the main competitors to etrasimod in pouchitis?
Key competitors include vedolizumab (Takeda, approved and Phase 3), combination antibiotic/immunosuppressive regimens (Takeda, Phase 3), and experimental approaches such as fecal microbiota transplantation (MAIA, Phase 1) and other small-molecule combinations (Lacuna Pharma, Phase 2).
What is pouchitis and who is affected?
Pouchitis is an inflammatory condition affecting patients who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis, typically performed for ulcerative colitis or familial adenomatous polyposis. It represents a significant unmet medical need with limited treatment options.
What is the unmet medical need in pouchitis treatment?
Current pouchitis treatments are limited and often involve antibiotics or immunosuppressive agents with variable efficacy and tolerability. An oral small-molecule agent with favorable safety and efficacy could address this therapeutic gap.
What is VELSIPITY and how does it relate to the pouchitis program?
VELSIPITY is the brand name for etrasimod arginine, an FDA-approved product (NDA216956) developed by Pfizer. MAIA Biotechnology is now developing this same compound for the pouchitis indication in Phase 2 trials.
When is the next expected milestone for the etrasimod pouchitis program?
The expected next milestone and its timing have not yet been disclosed in available sources.
What is the projected peak sales potential for etrasimod in pouchitis?
Projected peak sales figures have not yet been disclosed. Commercial potential is likely moderate given the specialized patient population affected by pouchitis.
Does etrasimod have any partnership agreements?
Partnership details and licensing arrangements between MAIA Biotechnology and other parties (including Pfizer) have not yet been disclosed.
What is the regulatory status of etrasimod in Europe, Japan, and China?
Regulatory status outside the United States (EMA, PMDA, NMPA) has not yet been disclosed for the pouchitis indication.
What is the molecular target of etrasimod?
The specific molecular target of etrasimod has not yet been disclosed in available sources.
Entity relationship graph
etrasimod → Drug → Target → Indication → Company → Trials → Competitors
Drugs
Molecular targets
Companies
Indication
Trials
Competitors
- Vedolizumab Placebo
- RIFAXIMIN , VANCOMYCIN , Entyvio 300 mg powder for concentrate for solution for infusion, AMOXICILLIN AND BETA-LACTAMASE INHIBITOR , CIPROFLOXACIN , METRONIDAZOLE
- Vedolizumab
- METRONIDAZOLE, FOSFOMYCIN, MOLGRAMOSTIM
- Fecal Microbiota Transplant (FMT)
- USTEKINUMAB
- TOFACITINIB
- LIRAGLUTIDE
- SARGRAMOSTIM
Analyst insights
Strategic Positioning: MAIA Biotechnology's development of etrasimod in pouchitis represents an indication-expansion strategy for a compound with established regulatory approval in another indication. This approach leverages prior safety and manufacturing data while targeting a specialized gastroenterology population with limited treatment options.
Competitive Implications: The program operates in a competitive but fragmented landscape. Vedolizumab (Takeda) represents the most established competitor with both approved and Phase 3 pouchitis programs. Etrasimod's oral route offers potential convenience advantages over intravenous vedolizumab, though efficacy and safety data are required to establish differentiation.
Clinical Development Catalysts: Key milestones include Phase 2 efficacy and safety readouts from NCT07486921, which will determine whether etrasimod advances to Phase 3 development. Mechanism of action disclosure would clarify the therapeutic rationale and potential patient population stratification.
Regulatory Pathway: Prior FDA approval of VELSIPITY may enable expedited development pathways (e.g., Fast Track designation) if Phase 2 data demonstrate clinical benefit in pouchitis. Regulatory interactions with FDA regarding indication-specific development requirements remain not yet disclosed.
Market Considerations: Pouchitis affects a defined but limited patient population, constraining peak sales potential. Commercial success will depend on efficacy superiority or convenience advantages over vedolizumab and emerging alternatives, combined with favorable reimbursement positioning in gastroenterology.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is etrasimod?
- Small-molecule oral therapeutic in Phase 2 development for pouchitis by MAIA Biotechnology.
- What indication is etrasimod being developed for?
- Pouchitis, an inflammatory condition in patients with ileal pouch-anal anastomosis.
- What is the current development phase?
- Phase 2; most recent milestone March 23, 2026.
- Who is developing etrasimod for pouchitis?
- MAIA Biotechnology (study code STUDY-25-01158).
- Is etrasimod approved by the FDA?
- VELSIPITY (etrasimod arginine) is FDA-approved (NDA216956, Pfizer sponsor) for another indication, not pouchitis.
- What is the route of administration?
- Oral.
- What is the drug modality?
- Small molecule.
- What is the mechanism of action?
- Not yet disclosed.
- What is the molecular target?
- Not yet disclosed.
- What is the brand name?
- VELSIPITY (for etrasimod arginine).
- Who originally developed VELSIPITY?
- Pfizer (FDA approval NDA216956).
- What is the primary clinical trial?
- NCT07486921, Phase 2 study; results not yet reported.
- What are the main competitors?
- Vedolizumab (Takeda, approved/Phase 3), antibiotic combinations (Takeda, Phase 3), FMT (MAIA, Phase 1).
- Does etrasimod have a partner?
- Partnership details not yet disclosed.
- What is the license type?
- License type not yet disclosed.
- What is the therapeutic class?
- Therapeutic class not yet disclosed.
- What is the projected peak sales?
- Peak sales projections not yet disclosed.
- When was etrasimod first disclosed?
- First disclosure date not yet disclosed.
- Who is the lead investigator?
- Lead investigator not yet disclosed.
- What is the expected next milestone?
- Expected next milestone and label not yet disclosed.
- Is etrasimod approved in Europe?
- EMA regulatory status not yet disclosed.
- Is etrasimod approved in Japan?
- PMDA regulatory status not yet disclosed.
- Is etrasimod approved in China?
- NMPA regulatory status not yet disclosed.
- What is pouchitis?
- Inflammatory condition affecting patients with ileal pouch-anal anastomosis, typically post-ulcerative colitis surgery.
- What is the patient population size?
- Patient population size not yet disclosed; represents specialized gastroenterology market.
- What is the consensus analyst position?
- Consensus analyst position not yet disclosed.
Evidence & sources
- ClinicalTrials.gov NCT07486921 (clinicaltrials)
- etrasimod arginine US status (fda)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0005312) (mondo)
- Orphanet — pouchitis (orphanet)
- NCT00061282 (clinicaltrials_gov)
- NCT00293553 (clinicaltrials_gov)
- NCT00583076 (clinicaltrials_gov)
- NCT00583531 (clinicaltrials_gov)
- NCT01202396 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.