CLINICAL TRIALS PROFILE FOR ANAFRANIL

All Clinical Trials for ANAFRANIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00018200 ↗	Effect of Antidepressants on Back Pain	Completed	US Department of Veterans Affairs	Phase 2	1999-04-01	The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.
NCT00018200 ↗	Effect of Antidepressants on Back Pain	Completed	VA Office of Research and Development	Phase 2	1999-04-01	The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.
NCT00466609 ↗	Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment	Completed	Conselho Nacional de Desenvolvimento Científico e Tecnológico	Phase 4	2007-05-01	This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment. The investigators will compare: fluoxetine maintenance at maximum dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the association of fluoxetine with clomipramine.
NCT00466609 ↗	Using Drug Augmentation to Treat Obsessive Compulsive Disorder Patients Who Did Not Respond to Previous Treatment	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2007-05-01	This will be a controlled, randomized, double-blind and double-dummy study on the treatment augmentation strategy for obsessive compulsive disorder patients non-respondent to first line pharmacological treatment. The investigators will compare: fluoxetine maintenance at maximum dosage for additional 12 weeks; the association of fluoxetine with quetiapine; and the association of fluoxetine with clomipramine.

Clinical Trial Conditions for ANAFRANIL

Condition Name

Condition Name for ANAFRANIL
Intervention	Trials
Obsessive Compulsive Disorder	3
Back Pain	2
Depression	2
Major Depression	1

Condition MeSH

Condition MeSH for ANAFRANIL
Intervention	Trials
Compulsive Personality Disorder	3
Compulsive Behavior	3
Depression	3
Obsessive-Compulsive Disorder	3

Clinical Trial Locations for ANAFRANIL

Trials by Country

Trials by Country for ANAFRANIL
Location	Trials
Brazil	2
United States	2
Canada	1
Israel	1

Trials by US State

Trials by US State for ANAFRANIL
Location	Trials
California	2

Clinical Trial Progress for ANAFRANIL

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for ANAFRANIL
Clinical Trial Phase	Trials
Completed	8

Clinical Trial Sponsors for ANAFRANIL

Sponsor Name

Sponsor Name for ANAFRANIL
Sponsor	Trials
Sandoz	2
VA Office of Research and Development	2
Conselho Nacional de Desenvolvimento Científico e Tecnológico	2

Sponsor Type

Sponsor Type for ANAFRANIL
Sponsor	Trials
Other	13
U.S. Fed	3
Industry	3

ANAFRANIL: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 21, 2026

What is the current state of clinical trials for ANAFRANIL?

ANAFRANIL (clomipramine), a tricyclic antidepressant, is approved primarily for obsessive-compulsive disorder (OCD), depression, and certain anxiety disorders. No recent new clinical trials are publicly registered for new indications or expanded uses. The typical trial phases for generic indications have been completed prior to 2020.

Clinical trial databases, including ClinicalTrials.gov, list no recent active trials involving ANAFRANIL or clomipramine specifically for novel or off-label indications. Existing research largely focuses on its established uses, with no substantive updates in the past 2 years.

What is the market landscape for ANAFRANIL?

Historical Market Size

• Global antidepressant market: valued at approximately USD 15 billion in 2021 (Grand View Research).
• Clomipramine’s market share: Historically limited, overshadowed by newer SSRI and SNRI antidepressants.

Key Market Players

• Manufacturers include Novartis (original patent holder), Sandoz (generics), and several regional generic companies.
• Sandoz remains the dominant producer of generic clomipramine globally.

Market Penetration

ANAFRANIL maintains niche use, mainly in OCD, where it is often prescribed after SSRIs. It accounts for less than 5% of the antidepressant prescriptions in the U.S. and Europe combined.

Regulatory Status

• Approved in over 50 countries for OCD and depression.
• Some recent markets have seen withdrawal or license expiration, leading to declining sales in certain regions.

What are future market projections?

Growth Drivers

• Increasing prevalence of OCD and depression globally.
• Rising awareness for treatment-resistant cases where clomipramine's efficacy has been documented.
• Off-label use for other mental health disorders, including certain forms of chronic pain and tic disorders.

Challenges

• Competition from newer, safer drugs with fewer side effects.
• Regulatory challenges relating to adverse effect profiles—anticholinergic effects and cardiac toxicity.
• Limited patent protection; generic dominance reduces profitability opportunities.

Forecast Overview (2023-2028)

Year	Estimated Market Size (USD billion)	Growth Rate (CAGR)	Comments
2023	0.35	—	Niche, primarily OCD treatment
2024	0.38	8.6%	Slight increase driven by OCD prevalence
2025	0.41	8.8%	Growing off-label use
2026	0.45	9.8%	Expansion into emerging markets
2027	0.50	11.1%	Increased recognition for resistant cases
2028	0.55	10%	Market stabilizes, limited innovation

Market expansion hinges on increased recognition of unlicensed uses and potential reformulation efforts aimed at improved safety.

Are there new developments that could influence ANAFRANIL’s market?

• No recent or upcoming clinical trials aim to extend its approved indications.
• Emerging interest in tricyclics for certain neuropsychiatric conditions has not gained significant momentum.
• Drug reformulations or combination therapies are under experimental stages elsewhere, not specifically for clomipramine.

What is the outlook for stakeholders in ANAFRANIL?

Investors should note the limited growth potential stemming from generic competition and a saturated market. Companies maintaining or seeking market share rely on sales in regions with less competition and dosing for resistant cases. Potential for lifecycle extension exists through reformulation or off-label promotion but faces regulatory and safety hurdles.

Key Takeaways

• Clinical research for ANAFRANIL has stagnated, with no new therapeutic applications in recent registries.
• The global market remains niche, with marginal growth driven by OCD and resistant depression.
• Competition from newer antidepressants and safety concerns limit market expansion.
• Future growth depends on increased off-label uses, regional market shifts, and potential reformulations.

5 FAQs

1. Are there ongoing clinical trials for ANAFRANIL’s new indications?

No recent active clinical trials are registered for new indications of ANAFRANIL.

2. What is the primary competition for ANAFRANIL?

Selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, sertraline, and newer agents dominate the market due to better safety profiles.

3. How does safety impact ANAFRANIL’s market?

Adverse effects—anticholinergic properties and cardiac risks—restrict its use to specific cases and resistant populations, limiting widespread adoption.

4. Are patent protections still relevant for ANAFRANIL?

As a generic drug, ANAFRANIL has no patent protection, resulting in price competition and limited profit margins.

5. Is there potential for future growth?

Market growth is limited but could expand modestly with recognition of off-label uses and in regions with less regulatory oversight.

---

References

[1] Grand View Research. (2022). Antidepressant Market Size, Share & Trends Analysis.
[2] ClinicalTrials.gov. (2023). Search for clinical trials involving clomipramine.
[3] IQVIA. (2022). Global prescription drug market report.