CLINICAL TRIALS PROFILE FOR ACTIGALL

All Clinical Trials for ACTIGALL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004315 ↗	Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease	Unknown status	Children's Hospital Medical Center, Cincinnati	Phase 2	1995-11-01	OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments.
NCT00004315 ↗	Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease	Unknown status	National Center for Research Resources (NCRR)	Phase 2	1995-11-01	OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease. II. Compare the differences in pruritus, weight gain, and liver function for both treatments.
NCT00042549 ↗	Lithotripsy for the Treatment of Gallstones	Terminated	Medstone International	Phase 4	2002-05-01	The purpose of this study is to determine the effectiveness and safety of using the Medstone lithotripter to treat single non-calcified gallstones from 4 to 20 mm in diameter.
NCT00877604 ↗	Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis	Completed	Federico II University	Phase 2	2008-06-01	The preclinical rationale for tauroursodeoxycholic acid (TUDCA) use in treating patients with amyotrophic lateral sclerosis (ALS) stems from the demonstration of antioxidant, antiapoptotic and neuroprotective properties of TUDCA in the central nervous system (CNS), both in vitro and in vivo models. This protocol is meant for assessing if the addition of TUDCA to the conventional therapy can improve the therapeutic outcome in patients affected by ALS. Safety will be assessed for all subjects, for the entire duration of the study. 30 patients affected by ALS with site of onset in the limbs will be recruited. All enrolled subjects will continue receiving riluzole at the same regimen as before entering the trial. Based on an appropriate random code, subjects will be divided into two groups of equal size treated, after a lead-in period of 3 months, by oral route with TUDCA at the dose 2 g daily for 1 year or with identical placebo by oral route at the same dosing schedule, under double-blind conditions. Every concomitant and/or supportive therapy will be admitted. Evaluation criteria: Efficacy. The proportion of responder patients in the two treatment groups was the primary outcome measure of the study. Responder patients were defined as those subjects showing an improvement of at least 15% in the ALSFRS-R (2) slope during the treatment period as compared to the lead-in period. This threshold was chosen based according to the consensus conference on designing and implementing clinical trials in ALS (3). Other parameters will include ALSFRS-R at study end, FVC%, the SF-36 quality of life rating scale, time to tracheotomy from starting of study medication dosing (if appropriate), survival Time from starting of study medication dosing (if appropriate), Medical Research Council scores for right and left muscle groups. Safety. Incidence, severity and type of adverse events; changes in clinical laboratory findings.
NCT00877604 ↗	Efficacy and Tolerability of Tauroursodeoxycholic Acid in Amyotrophic Lateral Sclerosis	Completed	University of Palermo	Phase 2	2008-06-01	The preclinical rationale for tauroursodeoxycholic acid (TUDCA) use in treating patients with amyotrophic lateral sclerosis (ALS) stems from the demonstration of antioxidant, antiapoptotic and neuroprotective properties of TUDCA in the central nervous system (CNS), both in vitro and in vivo models. This protocol is meant for assessing if the addition of TUDCA to the conventional therapy can improve the therapeutic outcome in patients affected by ALS. Safety will be assessed for all subjects, for the entire duration of the study. 30 patients affected by ALS with site of onset in the limbs will be recruited. All enrolled subjects will continue receiving riluzole at the same regimen as before entering the trial. Based on an appropriate random code, subjects will be divided into two groups of equal size treated, after a lead-in period of 3 months, by oral route with TUDCA at the dose 2 g daily for 1 year or with identical placebo by oral route at the same dosing schedule, under double-blind conditions. Every concomitant and/or supportive therapy will be admitted. Evaluation criteria: Efficacy. The proportion of responder patients in the two treatment groups was the primary outcome measure of the study. Responder patients were defined as those subjects showing an improvement of at least 15% in the ALSFRS-R (2) slope during the treatment period as compared to the lead-in period. This threshold was chosen based according to the consensus conference on designing and implementing clinical trials in ALS (3). Other parameters will include ALSFRS-R at study end, FVC%, the SF-36 quality of life rating scale, time to tracheotomy from starting of study medication dosing (if appropriate), survival Time from starting of study medication dosing (if appropriate), Medical Research Council scores for right and left muscle groups. Safety. Incidence, severity and type of adverse events; changes in clinical laboratory findings.

Clinical Trial Conditions for ACTIGALL

Condition Name

Condition Name for ACTIGALL
Intervention	Trials
Cholestasis	2
Amyotrophic Lateral Sclerosis	1
Barrett Esophagus	1
Cholelithiasis	1

Condition MeSH

Condition MeSH for ACTIGALL
Intervention	Trials
Cholestasis	2
Cholangitis	1
Gastrointestinal Diseases	1
Sclerosis	1

Clinical Trial Locations for ACTIGALL

Trials by Country

Trials by Country for ACTIGALL
Location	Trials
United States	16
Italy	1

Trials by US State

Trials by US State for ACTIGALL
Location	Trials
Texas	3
Arizona	2
North Carolina	1
Tennessee	1
Pennsylvania	1

Clinical Trial Progress for ACTIGALL

Clinical Trial Phase

Clinical Trial Phase for ACTIGALL
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for ACTIGALL
Clinical Trial Phase	Trials
Completed	3
Terminated	1
Unknown status	1

Clinical Trial Sponsors for ACTIGALL

Sponsor Name

Sponsor Name for ACTIGALL
Sponsor	Trials
Federico II University	1
University of California, San Francisco	1
University of Palermo	1

Sponsor Type

Sponsor Type for ACTIGALL
Sponsor	Trials
Other	18
NIH	2
Industry	1

ACTIGALL (Ursodeoxycholic Acid): Clinical Trials Update, Market Analysis, and Projection

Last updated: May 3, 2026

What is ACTIGALL and what are its core indications?

ACTIGALL is the brand name for ursodeoxycholic acid (UDCA), a bile acid used primarily in diseases related to impaired bile flow and biliary injury. In practice and labeling across major markets, UDCA is positioned for cholestatic and hepatobiliary conditions, including:

• Primary biliary cholangitis (PBC) (historically the flagship UDCA indication)
• Cholestatic disorders and selected bile-related indications where UDCA is used for bile acid replacement and symptomatic or biochemical improvement

ACTIGALL has been on the market for decades, and the clinical evidence base for UDCA predates current “modern” trial ecosystems in size and endpoints. Current activity is largely incremental: formulation changes, observational cohorts, and region-specific post-marketing studies rather than large, brand-new pivotal Phase 3 programs.

Is ACTIGALL in active clinical trials (and what does “update” mean here)?

For legacy drugs like ACTIGALL, “clinical trials update” typically breaks into three buckets:

1. ongoing observational registries and long-term follow-up studies,
2. therapeutic regimen evaluation (dose timing, combination use),
3. safety surveillance and real-world effectiveness studies.

No new ACTIGALL-specific late-stage pivotal program can be asserted from the available information in this prompt. A clean clinical-trials update for business planning requires trial-by-trial evidence (trial IDs, phases, sponsors, start and completion dates, recruitment status, and primary endpoints). This cannot be produced here without verifiable trial registry detail.

What does the clinical evidence landscape look like for UDCA/ACTIGALL?

UDCA’s clinical evidence is mature. The business implication is that:

• Competitive differentiation for ACTIGALL now comes less from breakthrough efficacy claims and more from product supply, pricing, payer positioning, and substitution risk from generics.
• Clinical development investment is typically not justified unless a new regulatory pathway, new patient subgroup, combination strategy, or a differentiated formulation can change benefit-risk versus the generic landscape.

A clinical “update” for ACTIGALL therefore tends to map to evolving PBC treatment standards (risk stratification, response-guided switching, and adjunctive therapies in later-line care) rather than new UDCA monotherapy endpoints.

How large is the ACTIGALL (UDCA) market and what drives demand?

ACTIGALL competes within the bile acid and cholestatic liver disease treatment arena. Demand drivers are structural and tied to:

• Diagnosed PBC and other cholestatic liver diseases
• Long duration of therapy (UDCA is chronic in clinical use for appropriate patients)
• Generic substitution dynamics (UDCA is a widely available off-patent molecule in many jurisdictions)
• Guideline adherence and payer behavior around first-line therapy selection

Key market realities for an off-patent molecule:

• Price pressure is persistent because multiple manufacturers can supply UDCA tablets or capsules.
• Manufacturer differentiation depends on supply reliability, bioequivalence positioning, patient assistance and contracting, and switching barriers (where regulatory or formulary mechanisms restrict interchangeability).

Where does competitive intensity come from?

ACTIGALL faces two broad competitive forces:

1. Generic UDCA substitution

• Most health systems can source UDCA from generic manufacturers, compressing net pricing.

2. Therapeutic alternatives and add-on strategies in PBC

• In PBC, clinicians increasingly use response-guided pathways and may layer or switch therapies based on biochemical response, risk scores, and disease progression markers.

For ACTIGALL, the practical forecast hinges on the share of patients remaining on UDCA monotherapy long enough for sustained revenue.

What is the revenue outlook and how should investors model it?

ACTIGALL’s revenue trajectory is best modeled as a “legacy chronic therapy” curve:

• Revenue is maintained by prescription volume and payer coverage.
• Net sales decline is driven by generic erosion unless ACTIGALL retains differentiated formulary status or achieves favorable contracting.
• Uptake is limited by the mature position of UDCA in guidelines and by competition from other PBC management strategies.

A credible projection requires baseline values (current net sales by geography, unit volume, wholesale acquisition cost, and payer mix). That data is not provided in the prompt. Without those inputs, a precise numeric forecast cannot be produced in an evidence-grade format.

What is the R&D pipeline risk and upside for ACTIGALL?

UDCA’s molecule is the same across manufacturers. For brand-level upside, ACTIGALL can only materially change outlook if it achieves one of the following:

• Differentiated product attributes (formulation, stability, dosing convenience)
• New regulatory expansion with a strong clinical package
• Durable contracting that protects net price against generics
• Combination/regimen claims that regulators accept (less common for off-patent brands)

Pipeline risk is mostly linked to:

• Continued generic penetration
• Guideline evolution that reduces UDCA monotherapy duration in subgroups with inadequate response
• Patent and exclusivity realities for product-specific rights (if any) that may expire regionally

Regulatory and exclusivity posture: what matters for forecasting?

Forecasting ACTIGALL revenue depends on:

• Remaining brand market authorizations in each region
• Extent of generic interchangeability and substitution rules
• Product-specific exclusivity (if any) that can delay generic erosion

Because this prompt does not supply jurisdictional exclusivity details or current pricing, exclusivity modeling cannot be completed here.

Market projection framework (usable without ACTIGALL-specific numeric inputs)

Use this structure for a business plan or investment diligence model for an off-patent bile acid brand:

1) Volume

• Patient prevalence in treated cholestatic liver disease categories
• Prescription renewals and persistence
• Switch rates out of UDCA based on guideline response monitoring

2) Net price

• Generic penetration rate by geography and payer
• Contracting cycles and formulary placement stability
• Evidence of therapeutic interchange in pharmacy benefit design

3) Geography mix

• Countries where branded supply still holds share due to contracting or limited generic uptake
• Countries with rapid substitution and sharper price compression

4) Regulatory and pharmacovigilance

• Safety signals that influence prescribing habits (for UDCA, safety is generally established)
• Label updates that shift recommended patient selection

5) Cost to serve

• Manufacturing economics and supply continuity
• Logistics and inventory carrying risk (chronic therapies create ongoing fill obligations)

Can we quantify a forward CAGR for ACTIGALL?

A quantified CAGR or year-by-year numeric projection requires at minimum:

• Current net sales (by region and total)
• Unit volume and net price trends
• Generic penetration trend rate and expected formulary displacement

This information is not included in the prompt, so a complete and accurate numeric projection cannot be generated.

What decision-ready takeaways can be made now?

ACTIGALL is a mature, off-patent UDCA brand. The forecast for any such product is driven by generic substitution and the portion of the patient population that remains on UDCA-based management over time. The clinical evidence base is established; the future risk and upside are mainly commercial and guideline-driven rather than coming from new Phase 3 efficacy breakthroughs.

---

Key Takeaways

• ACTIGALL is ursodeoxycholic acid (UDCA), a mature therapy with established use in cholestatic and biliary liver conditions, including PBC.
• “Clinical trials update” for ACTIGALL is likely dominated by observational, long-term, and regimen evaluation rather than brand-defining pivotal Phase 3 programs.
• Market outlook is mainly shaped by generic substitution and payer formulary placement, with guideline-driven switching influencing UDCA persistence.
• A numeric market projection requires current sales, unit volume, net price trend, and generic penetration assumptions; those inputs are not provided here, so an evidence-grade quantified forecast cannot be stated.

---

FAQs

1) What is ACTIGALL’s active ingredient?

ACTIGALL’s active ingredient is ursodeoxycholic acid (UDCA).

2) Why does ACTIGALL’s market growth usually lag?

Because UDCA is widely off-patent and faces generic substitution, and its clinical positioning is mature within biliary and cholestatic disease guidelines.

3) What drives prescriptions for UDCA in practice?

Diagnosis of cholestatic liver disease and clinician adherence to bile-acid therapy pathways, with ongoing persistence influenced by response monitoring.

4) What is the main commercial risk for ACTIGALL?

Net price erosion from generic UDCA substitution and formulary displacement over contracting cycles.

5) What would create meaningful upside for ACTIGALL?

Regimen or product differentiation that regulators accept and payers reimburse in a way that reduces substitution or extends treatment duration.

---

References

No sources were provided in the prompt.