CLINICAL TRIALS PROFILE FOR NEXICLON XR

All Clinical Trials for NEXICLON XR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00588354 ↗	Epidural Clonidine for Lumbosacral Radiculopathy	Terminated	National Center for Research Resources (NCRR)	N/A	2006-10-01	This was a randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. The hypothesis was that clonidine will be as effective as steroid for this condition.
NCT00588354 ↗	Epidural Clonidine for Lumbosacral Radiculopathy	Terminated	Mayo Clinic	N/A	2006-10-01	This was a randomized, blinded study of transforaminal epidural injection of clonidine versus a similar injection of corticosteroid for acute lumbosacral radiculopathy. The hypothesis was that clonidine will be as effective as steroid for this condition.
NCT00884832 ↗	A Placebo-Controlled Study of Clonidine for Fecal Incontinence.	Completed	National Center for Research Resources (NCRR)	Phase 2	2008-10-01	Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic are doing a research study to assess the effects of a medication, clonidine, on fecal incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug Administration (FDA) for treating high blood pressure, but not for treating incontinence and rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence, increase rectal capacity and reduce rectal sensation to a greater extent than placebo in women.
NCT00884832 ↗	A Placebo-Controlled Study of Clonidine for Fecal Incontinence.	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2	2008-10-01	Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic are doing a research study to assess the effects of a medication, clonidine, on fecal incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug Administration (FDA) for treating high blood pressure, but not for treating incontinence and rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence, increase rectal capacity and reduce rectal sensation to a greater extent than placebo in women.
NCT00884832 ↗	A Placebo-Controlled Study of Clonidine for Fecal Incontinence.	Completed	Mayo Clinic	Phase 2	2008-10-01	Fecal incontinence is the involuntary leakage of stool from the anus. Doctors at Mayo Clinic are doing a research study to assess the effects of a medication, clonidine, on fecal incontinence and rectal functions in women. Clonidine has been approved by the Food and Drug Administration (FDA) for treating high blood pressure, but not for treating incontinence and rectal functions. The hypothesis of this study is clonidine will improve fecal incontinence, increase rectal capacity and reduce rectal sensation to a greater extent than placebo in women.

Clinical Trial Conditions for NEXICLON XR

Condition Name

Condition Name for NEXICLON XR
Intervention	Trials
Fecal Incontinence	1
Lumbar and Other Intervertebral Disc Disorders With Radiculopathy	1
Pain Management	1
Postoperative Pain	1

Condition MeSH

Condition MeSH for NEXICLON XR
Intervention	Trials
Pain, Postoperative	1
Fecal Incontinence	1
Radiculopathy	1
Intervertebral Disc Displacement	1

Clinical Trial Locations for NEXICLON XR

Trials by Country

Trials by Country for NEXICLON XR
Location	Trials
United States	3

Trials by US State

Trials by US State for NEXICLON XR
Location	Trials
Minnesota	2
Pennsylvania	1

Clinical Trial Progress for NEXICLON XR

Clinical Trial Phase

Clinical Trial Phase for NEXICLON XR
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
N/A	2

Clinical Trial Status

Clinical Trial Status for NEXICLON XR
Clinical Trial Phase	Trials
Terminated	2
Completed	1
Withdrawn	1

Clinical Trial Sponsors for NEXICLON XR

Sponsor Name

Sponsor Name for NEXICLON XR
Sponsor	Trials
Mayo Clinic	2
National Center for Research Resources (NCRR)	2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

Sponsor Type

Sponsor Type for NEXICLON XR
Sponsor	Trials
Other	6
NIH	3

NEXICLON XR Clinical Trials Update, Market Analysis, and Near-Term Pricing/Exclusivity Projection

Last updated: August 1, 2026

What is NEXICLON XR and what is its regulatory status in the US?

NEXICLON XR is not a sufficiently identifiable, uniquely named FDA-cleared prescription drug product in the public domain based on the provided input. Without an unambiguous link to the active ingredient (or ANDA/BLA/NDA identifier), the Orange Book listing status, labeling, and FDA pathway cannot be mapped to a specific regulatory record.

Which clinical trials for NEXICLON XR are ongoing or completed?

No verifiable clinical trial program can be mapped to “NEXICLON XR” from the provided input. A complete, accurate trials update requires the active ingredient, sponsor, trial identifiers (NCT/EudraCT/ISRCTN), or the drug’s specific FDA submission reference, none of which are supplied.

What are the top indications, endpoints, and study designs for NEXICLON XR?

No verifiable indication, trial endpoints, or study design details can be attributed to “NEXICLON XR” from the provided input.

Who is developing NEXICLON XR and who are the likely competitors?

No verifiable developer name or competitor set can be constructed for “NEXICLON XR” from the provided input. Competitor mapping depends on active ingredient, dosage forms, and therapeutic class.

What is the market size and forecast for NEXICLON XR (US and major ex-US markets)?

No market forecast can be produced for “NEXICLON XR” without the active ingredient and approved indication, since demand drivers, payer coverage, and competitive intensity vary by therapeutic use and formulation class.

How does NEXICLON XR compare with other extended-release drugs in the same class?

A comparative landscape requires the specific molecule and formulation attributes (release profile, dose range, route, and indication). None are provided.

When does NEXICLON XR lose exclusivity in the US (patents and regulatory exclusivity)?

A US exclusivity timeline requires Orange Book patent listings and FDA exclusivity grants tied to an NDA/ANDA/BLA. No NDA/ANDA/BLA identifier is provided.

What is the Orange Book status of NEXICLON XR and which patents protect it?

Orange Book status and protecting patents cannot be identified from “NEXICLON XR” alone. This includes inability to enumerate listed patents, expiration dates, and method/formulation coverage.

What patent challenges could threaten NEXICLON XR (Paragraph IV / biosimilar risk)?

Paragraph IV or biosimilar risk depends on whether the product is an ANDA-listed small-molecule, a biologic (BLA), and the specific patent estate listed in the Orange Book. None of those inputs are present.

Are there active patent litigations involving NEXICLON XR and what are their outcomes?

Litigation status requires dockets, case captions, and patent numbers or FDA identifiers. None are provided.

What are the likely generic entry scenarios and launch timing risks for NEXICLON XR?

Generic launch timing depends on patent expiration, exclusivity periods, settlement terms, and FDA approval pathway. None of these inputs can be tied to “NEXICLON XR” from the provided content.

Key Takeaways

• No credible clinical-trials update, Orange Book/exclusivity mapping, or market projection can be produced for “NEXICLON XR” using the provided input alone.

FAQs

1. What is the FDA approval pathway for NEXICLON XR?
2. What NCT trials include NEXICLON XR and what phases are they in?
3. Which patents listed in the Orange Book cover NEXICLON XR formulations?
4. Are there Paragraph IV filings for NEXICLON XR, and what patents were challenged?
5. What is the expected pricing and reimbursement trajectory for NEXICLON XR in Medicare/Commercial plans?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.