CLINICAL TRIALS PROFILE FOR XARACOLL

All Clinical Trials for XARACOLL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02232178 ↗	Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant	Completed	Premier Research Group plc	Phase 2	2014-10-20	Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.
NCT02232178 ↗	Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant	Completed	Innocoll	Phase 2	2014-10-20	Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltration.
NCT02523599 ↗	Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty	Completed	Innocoll	Phase 3	2015-08-01	This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled efficacy and safety study of postoperative pain in adults who are scheduled for unilateral inguinal hernioplasty via open laparotomy (tension-free technique). Patients will assess their postoperative pain intensity (PI) using an 11-point numerical rating scale (NRS) from 0 hour through 72 hours postoperatively. The expected maximum study duration for each patient will be up to 60 days, including a maximum 30-day screening period, the day of surgery and implantation, and a 30-day post implantation period including treatment and follow-up.
NCT02525133 ↗	Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty	Completed	Innocoll	Phase 3	2015-09-05	This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled efficacy and safety study of postoperative pain in adults who are scheduled for unilateral inguinal hernioplasty via open laparotomy (tension-free technique). Patients will assess their postoperative pain intensity (PI) using an 11-point numerical rating scale (NRS) from 0 hour through 72 hours postoperatively. The expected maximum study duration for each patient will be up to 60 days, including a maximum 30-day screening period, the day of surgery and implantation, and a 30-day post implantation period including treatment and follow-up.

Clinical Trial Conditions for XARACOLL

Condition Name

Condition Name for XARACOLL
Intervention	Trials
Pain, Postoperative	2
Hernioplasty	1
Inguinal Hernia	1
Postoperative Pain	1

Condition MeSH

Condition MeSH for XARACOLL
Intervention	Trials
Pain, Postoperative	3
Hernia, Umbilical	1
Hernia, Inguinal	1
Hernia	1

Clinical Trial Locations for XARACOLL

Trials by Country

Trials by Country for XARACOLL
Location	Trials
United States	33

Trials by US State

Trials by US State for XARACOLL
Location	Trials
Texas	4
Florida	3
California	3
Alabama	3
Utah	2

Clinical Trial Progress for XARACOLL

Clinical Trial Phase

Clinical Trial Phase for XARACOLL
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for XARACOLL
Clinical Trial Phase	Trials
Completed	3
Recruiting	1

Clinical Trial Sponsors for XARACOLL

Sponsor Name

Sponsor Name for XARACOLL
Sponsor	Trials
Innocoll	4
Premier Research Group plc	2
Cmed	1

Sponsor Type

Sponsor Type for XARACOLL
Sponsor	Trials
Industry	6
Other	1

Last updated: May 3, 2026

XARACOLL Clinical Trials Update, Market Analysis, and 2026–2036 Projection

What is XARACOLL and where is it in clinical development?

No information is available in the provided context that identifies XARACOLL as a defined drug product with a corresponding INN/brand-to-molecule mapping, sponsor, route of administration, trial registry IDs (e.g., NCT/EudraCT), or published phase-by-phase results. Without that mapping, a complete and accurate clinical trials update cannot be produced.

Which clinical trials exist, what phase are they in, and what are the readouts?

No trial identifiers, endpoints, enrollment status, or data cut dates are available for XARACOLL in the provided context. A reliable trials update requires, at minimum, verifiable records such as NCT numbers, EudraCT, trial phase, recruitment status, primary endpoints, and published interim/final results.

What is the market size today and how much does XARACOLL capture by 2026–2036?

No product attributes are available (active ingredient, mechanism, indication, formulation, target population, comparator landscape, pricing assumptions, or payer context). Without those inputs, a market sizing and capture model cannot be constructed without risking inaccuracies.

What is the competitive landscape and how does XARACOLL position vs substitutes?

No indication, mechanism, or target patient segment is provided for XARACOLL, so competitive substitution (branded, generic, biologics, device or procedural alternatives), projected share, and switching dynamics cannot be determined.

What are the key commercial drivers and risks for revenue projections?

A projection requires at least the following structured facts: indication(s), dosing regimen, treatment duration, clinical differentiation claims, safety profile, regulatory pathway status, and estimated time to approvals. None of these are available for XARACOLL in the provided context.

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Market projection framework (what must be measurable for a valid forecast)

A valid 2026–2036 model for a defined drug requires these measurable anchors:

Forecast module	Required data points	Missing for XARACOLL (in provided context)
Clinical anchor	Phase, indication, endpoints, efficacy/safety signals, data cut dates	Unknown
Regulatory timeline	Submission type, target decision dates, agency feedback signals	Unknown
Pricing & reimbursement	Wholesale price, net price assumptions, market access, reimbursement category	Unknown
Demand model	Eligible population, diagnosis rates, persistence, adherence, line of therapy distribution	Unknown
Competition & substitution	Current standard-of-care utilization, competitor pipeline, switching costs	Unknown

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Key Takeaways

• A complete and accurate clinical trials update and market analysis/projection for XARACOLL cannot be produced from the provided context because the drug cannot be mapped to a verifiable molecular identity, indication, trial registry records, or commercial parameters.
• No reliable phase status, trial readouts, enrollment, or regulatory milestones can be stated.
• No credible market size, share capture, or revenue forecast can be quantified.

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FAQs

1. What information is needed to update XARACOLL’s clinical trials?
   Trial registry identifiers (e.g., NCT/EudraCT), sponsor, phase, recruitment status, endpoints, and published results with data cut dates.

2. Can a market projection be built without an indication and mechanism of action?
   No. Market sizing and share depend on indication, patient population, dosing schedule, and reimbursement dynamics.

3. Does XARACOLL correspond to a known INN/active ingredient?
   Not determinable from the provided context.

4. What would change the 2026–2036 revenue forecast most?
   Approval timing, label breadth, comparative efficacy and safety, net pricing, and persistence.

5. Where do the most authoritative clinical and regulatory facts come from?
   Public trial registries, regulatory agency filings, and peer-reviewed publications tied to the exact product identity.

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References

No sources were provided in the prompt, and no verifiable citations for XARACOLL’s identity, trials, or market facts can be generated from the provided context.