CLINICAL TRIALS PROFILE FOR NEFAZODONE HYDROCHLORIDE

All Clinical Trials for nefazodone hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000286 ↗	Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3	Completed	University of Minnesota	Phase 2	1996-12-01	The purpose of this study is to determine the effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users.
NCT00000286 ↗	Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 2	1996-12-01	The purpose of this study is to determine the effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users.
NCT00000286 ↗	Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1996-12-01	The purpose of this study is to determine the effects of nefazedone on cocaine self-administration in depressed and non-depressed female cocaine users.
NCT00000293 ↗	Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10	Completed	University of Minnesota	Phase 3	1999-01-01	The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use in depressed and non-depressed females with cocaine abuse/dependence.
NCT00000293 ↗	Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10	Completed	University of Minnesota - Clinical and Translational Science Institute	Phase 3	1999-01-01	The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use in depressed and non-depressed females with cocaine abuse/dependence.
NCT00000293 ↗	Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10	Completed	National Institute on Drug Abuse (NIDA)	Phase 3	1999-01-01	The purpose of this study is to determine the effect of nefazodone on relapse to cocaine use in depressed and non-depressed females with cocaine abuse/dependence.
NCT00015210 ↗	Nefazodone in the Treatment of Cocaine Dependence and Depression - 4	Completed	Boston University	Phase 2	1997-02-01	The purpose of this study is the use of Nefazodone in the treatment of cocaine dependence and depression comorbidity.

Clinical Trial Conditions for nefazodone hydrochloride

Condition Name

Condition Name for nefazodone hydrochloride
Intervention	Trials
Cocaine-Related Disorders	3
Panic Disorder	2
Stress Disorders, Post-Traumatic	2
Major Depressive Disorder With Panic Attacks	1

Condition MeSH

Condition MeSH for nefazodone hydrochloride
Intervention	Trials
Depressive Disorder, Major	3
Disease	3
Cocaine-Related Disorders	3
Depressive Disorder	2

Clinical Trial Locations for nefazodone hydrochloride

Trials by Country

Trials by Country for nefazodone hydrochloride
Location	Trials
United States	17
Israel	1
Canada	1
Mexico	1
United Kingdom	1

Trials by US State

Trials by US State for nefazodone hydrochloride
Location	Trials
New York	5
North Carolina	2
New Mexico	2
California	2
Minnesota	2

Clinical Trial Progress for nefazodone hydrochloride

Clinical Trial Phase

Clinical Trial Phase for nefazodone hydrochloride
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	8

Clinical Trial Status

Clinical Trial Status for nefazodone hydrochloride
Clinical Trial Phase	Trials
Completed	13
Unknown status	2
Terminated	1

Clinical Trial Sponsors for nefazodone hydrochloride

Sponsor Name

Sponsor Name for nefazodone hydrochloride
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	3
University of Minnesota - Clinical and Translational Science Institute	2
VA Office of Research and Development	2

Sponsor Type

Sponsor Type for nefazodone hydrochloride
Sponsor	Trials
Other	18
U.S. Fed	5
NIH	3

Last updated: July 27, 2026

Nefazodone Hydrochloride clinical trials update, market analysis, and pricing-volume projections (2026)

No complete, auditable dataset is available here to produce a complete and accurate, decision-grade update on (1) active or recently completed clinical trials, (2) current market size or revenue trend, or (3) reliable forward projections for nefazodone hydrochloride.

What clinical trials updates exist for nefazodone hydrochloride (2023–2026)?

No verified trial record set is available in the provided material to enumerate:

• NCT numbers and statuses
• study designs (placebo-controlled, dose-ranging, endpoints)
• enrollment and completion dates
• sponsor and geography
• safety outcomes and efficacy readouts
• publication links

Which indications have current development programs for nefazodone hydrochloride?

No indication-specific, source-anchored pipeline information is available here.

Is nefazodone hydrochloride in phase 2 or phase 3 right now?

No phase/status evidence is available here.

What efficacy and safety signals were reported in the latest nefazodone trials?

No trial-level outcomes are available here.

Are there ongoing trials that support FDA submission pathways for nefazodone?

No regulatory-linked trial evidence is available here.

How big is the market for nefazodone hydrochloride and what are the key drivers?

No market sizing, payer coverage, or utilization dataset is available here to quantify:

• historical sales trend
• geography (US vs ex-US)
• channel mix (retail vs mail)
• branded vs generic share
• formulary position drivers
• competitor class dynamics (other antidepressants)

What is the competitive landscape for nefazodone versus other antidepressants?

No competitor revenue or prescribing-share evidence is available here.

What pricing and volume levers typically move nefazodone demand?

No nefazodone-specific commercial drivers are available here.

Does nefazodone face formulary or safety-driven utilization constraints?

No formulary or safety surveillance dataset is available here.

When does nefazodone hydrochloride lose exclusivity, and what generic entry risks exist?

No Orange Book, exclusivity, patent estate, or litigation dataset is available here to determine:

• patent expiration windows
• 180-day exclusivity triggers
• Paragraph IV filings
• settlement dates and “at-risk” generic timelines
• authorized generic arrangements

What patents protect nefazodone hydrochloride?

No patent list is available here.

What is the Orange Book status of nefazodone hydrochloride?

No listing status is available here.

Which companies are challenging nefazodone patents?

No challenger names or case numbers are available here.

How does settlement affect expected generic launch timing for nefazodone?

No settlement records are available here.

How should nefazodone hydrochloride market projections be modeled for 2026–2031?

No auditable inputs are available here to model a projection with credible assumptions tied to:

• trial readouts and launch timing
• regulatory events
• generic entry milestones
• supply constraints
• payer restrictions
• price erosion curves

What is the base-case projection for nefazodone revenue?

No projection inputs are available here.

What is the downside case if generic entry accelerates?

No generic-timing evidence is available here.

What is the upside case if new indications or label expansions occur?

No clinical development evidence is available here.

What regulatory status does nefazodone hydrochloride have at FDA?

No FDA status evidence is available here to report:

• NDA/BLA status (approved, withdrawn, discontinued)
• current marketing authorization (active label)
• label constraints
• REMS requirements (if any)
• manufacturing site status
• safety communications impacting demand

What FDA review history affects current access for nefazodone hydrochloride?

No FDA review-history evidence is available here.

Are there REMS or safety monitoring requirements for nefazodone?

No evidence is available here.

Key Takeaways

• No source-anchored clinical trials dataset is available here to provide an accurate update for nefazodone hydrochloride.
• No source-anchored market or revenue dataset is available here to quantify current market size or provide a credible 2026–2031 projection.
• No source-anchored exclusivity/patent or FDA regulatory-status dataset is available here to model generic entry risks or forecast price-volume erosion.

FAQs

1. What are the most recent NCT numbers for nefazodone hydrochloride?
2. What is the latest FDA labeling status for nefazodone hydrochloride?
3. Which manufacturers market nefazodone hydrochloride in the US currently?
4. Are there any recent safety communications or pharmacovigilance signals affecting nefazodone demand?
5. What generic entry scenarios exist for nefazodone hydrochloride and when would they occur?

References

(No citations provided because no source material was supplied that can be cited in-line.)