CLINICAL TRIALS PROFILE FOR SEROMYCIN

All Clinical Trials for Seromycin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00182000 ↗	Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy	Completed	Hartford Hospital	Phase 3	2003-11-01	This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).
NCT00182000 ↗	Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy	Completed	Massachusetts General Hospital	Phase 3	2003-11-01	This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).
NCT00198120 ↗	Safety and Effectiveness of D-Cycloserine in Children With Autism	Completed	Indiana University School of Medicine	Phase 3	2004-02-01	This study will determine the effectiveness of D-cycloserine in reducing symptoms of autism in autistic children.
NCT00198120 ↗	Safety and Effectiveness of D-Cycloserine in Children With Autism	Completed	National Alliance for Research on Schizophrenia and Depression	Phase 3	2004-02-01	This study will determine the effectiveness of D-cycloserine in reducing symptoms of autism in autistic children.
NCT00198120 ↗	Safety and Effectiveness of D-Cycloserine in Children With Autism	Completed	National Institute of Mental Health (NIMH)	Phase 3	2004-02-01	This study will determine the effectiveness of D-cycloserine in reducing symptoms of autism in autistic children.
NCT00198120 ↗	Safety and Effectiveness of D-Cycloserine in Children With Autism	Completed	Indiana University	Phase 3	2004-02-01	This study will determine the effectiveness of D-cycloserine in reducing symptoms of autism in autistic children.
NCT00408031 ↗	D-cycloserine for Major Depressive Disorder	Completed	National Alliance for Research on Schizophrenia and Depression	Phase 2	2007-01-01	For many depression patients treatment changes are required, including switching to another antidepressant and addition of a second antidepressant or a non-antidepressant agent ("augmentation"). The need to modify treatment is usually necessary because of partial or no response to first-line monotherapy or the failure to achieve remission although treatment response (improvement) has been obtained. These caveats of presently available antidepressant drugs highlight the need for innovative pharmacological treatment strategies. Recent data suggest that N-methyl-D-aspartate receptor (NMDAR) antagonists and partial agonists at the NMDAR-associated glycine binding site may represent a novel type of antidepressant medications. These types of compounds protect vulnerable neurons against a variety of insults, including stress-induced damage, and may serve to enhance and maintain normal synaptic connectivity. In animal models, these compounds mimic the effects of clinically effective antidepressants. Furthermore, down-regulation of the glycine site of the NMDAR was found to be a common feature of currently used antidepressant medications. D-cycloserine (DCS , Seromycin) is a broad spectrum antibiotic, in use for over thirty years against tuberculosis, that acts as a partial agonist at the NMDAR-associated glycine site. Beneficial antidepressant effects have been reported with 500-1000 mg/day DCS regimens in depressed tuberculosis patients and recent preliminary findings suggest that DCS may also be beneficial in the treatment of major depressive disorder. The antidepressant effects of DCS seem to reflect consequences of its capacity to reduce NMDAR receptor function. In the present project, it is proposed to assess, using a random assignment, parallel-group, double blind, placebo controlled design, the effects of a NMDAR -antagonist DCS dose regimen, 250 --> 1000 mg/day for 6 wks, as adjuvant pharmacotherapy for treatment-resistant major depressive disorder patients. The study methodology includes the assessment of DCS effects upon symptoms profile, neurocognitive tests performance, amino acids serum levels, and brain electrophysiology parameters associated with the prepulse inhibition-startle response paradigm. It is hypothesized that significant beneficial DCS treatment effects will be registered.

Clinical Trial Conditions for Seromycin

Condition Name

Condition Name for Seromycin
Intervention	Trials
Obsessive-Compulsive Disorder	4
Schizophrenia	3
Major Depressive Disorder	3
Autistic Disorder	2

Condition MeSH

Condition MeSH for Seromycin
Intervention	Trials
Disease	7
Obsessive-Compulsive Disorder	4
Compulsive Personality Disorder	4
Depressive Disorder	4

Clinical Trial Locations for Seromycin

Trials by Country

Trials by Country for Seromycin
Location	Trials
United States	26
Canada	6
Israel	3

Trials by US State

Trials by US State for Seromycin
Location	Trials
Massachusetts	5
Illinois	2
Georgia	2
Texas	2
Florida	2

Clinical Trial Progress for Seromycin

Clinical Trial Phase

Clinical Trial Phase for Seromycin
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	4
Phase 2	12

Clinical Trial Status

Clinical Trial Status for Seromycin
Clinical Trial Phase	Trials
Completed	19
Unknown status	4
Recruiting	2

Clinical Trial Sponsors for Seromycin

Sponsor Name

Sponsor Name for Seromycin
Sponsor	Trials
University of Calgary	5
National Institute of Mental Health (NIMH)	5
Massachusetts General Hospital	4

Sponsor Type

Sponsor Type for Seromycin
Sponsor	Trials
Other	46
NIH	9
U.S. Fed	1

Clinical Trials, Market Analysis, and Projections for Seromycin (Cycloserine)

Introduction

Seromycin, also known as cycloserine, is an antibiotic used primarily in the treatment of tuberculosis and certain other bacterial infections. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Historical Use and Mechanism of Action

Seromycin has been in use for several decades, primarily for treating tuberculosis, especially when the primary medications are inadequate. Its mechanism of action involves inhibiting cell-wall synthesis in susceptible strains of gram-positive and gram-negative bacteria[4].

Current Clinical Trials and Research

While Seromycin is not a new drug, it has been involved in various clinical trials and research studies, particularly in combination with other treatments. For instance, there has been interest in its use as an adjunctive treatment in psychiatric conditions. A recent clinical trial explored the efficacy of D-cycloserine (the same active ingredient as Seromycin) in enhancing transcranial magnetic stimulation (TMS) treatment for depression. The results showed significant improvements in patients receiving D-cycloserine compared to those receiving a placebo, highlighting its potential in psychiatric treatments[1].

Market Analysis

Current Market Position

Seromycin is a niche drug with a specific market due to its limited indications. It is primarily used in the treatment of tuberculosis and certain bacterial infections where other treatments have failed. The market for antituberculosis drugs is relatively stable but not highly lucrative compared to other therapeutic areas.

Pricing and Accessibility

One of the significant challenges with Seromycin is its pricing. There have been reports of dramatic price increases, which can make the drug inaccessible to many patients. For example, the price of Seromycin has been noted to rise from $480 to $10,800, highlighting the issue of rising healthcare costs and their impact on patient access[5].

Market Projections

Growth in Clinical Trials Market

The broader clinical trials market, which includes various therapeutic areas, is expected to grow significantly. The U.S. clinical trials market is projected to increase from $27.07 billion in 2024 to $41.57 billion by 2033, with a CAGR of 4.88% during the forecast period. While Seromycin itself may not be a major contributor to this growth, the overall expansion of clinical trials could lead to more research and potential new indications for the drug[3].

Therapeutic Area Growth

The oncology segment, which accounts for the largest revenue share in clinical trials, is not directly relevant to Seromycin. However, the autoimmune segment, which is the second most lucrative, could see some impact if Seromycin is explored for use in autoimmune diseases. The autoimmune segment is expected to grow with a CAGR of 5.6% during the forecast period[3].

Future Prospects and Challenges

Potential New Indications

While Seromycin's primary use remains in tuberculosis treatment, its adjunctive use in psychiatric conditions, as seen in the clinical trial with D-cycloserine, opens up new potential markets. Further research could expand its indications, potentially increasing its market share.

Regulatory and Safety Considerations

Seromycin's use is regulated by stringent protocols, and it must be used under close medical supervision due to potential serious adverse reactions. Ensuring safety and efficacy will remain crucial for any new indications or market expansion[4].

Pricing and Accessibility Issues

The significant price increases of Seromycin pose a major challenge. Addressing these issues through pricing reforms or alternative manufacturing options could improve accessibility and market penetration.

Key Takeaways

• Clinical Trials: Seromycin has shown promise in adjunctive treatments, such as enhancing TMS for depression.
• Market Position: It holds a niche position primarily in tuberculosis treatment.
• Pricing: Significant price increases have made the drug less accessible.
• Market Projections: The broader clinical trials market is expected to grow, but Seromycin's growth will depend on new indications and addressing pricing issues.
• Future Prospects: Potential new indications, especially in psychiatric conditions, could expand its market.

FAQs

What is Seromycin primarily used for?

Seromycin is primarily used in the treatment of active pulmonary and extrapulmonary tuberculosis when the causative organisms are susceptible to this drug and other primary medications have proven inadequate[4].

Has Seromycin been involved in recent clinical trials?

Yes, Seromycin (or its active ingredient D-cycloserine) has been involved in recent clinical trials, particularly in exploring its adjunctive use in psychiatric treatments like enhancing TMS for depression[1].

Why has the price of Seromycin increased significantly?

The price of Seromycin has increased dramatically, making it less accessible to patients. This is part of a broader trend of rising healthcare costs[5].

What are the potential new indications for Seromycin?

Potential new indications include its use in psychiatric conditions, such as depression, where it has shown promise as an adjunctive treatment[1].

What are the main challenges facing Seromycin in the market?

The main challenges include pricing and accessibility issues, as well as the need to ensure safety and efficacy under close medical supervision[4][5].

Sources

1. Efficacy of Adjunctive D-Cycloserine to Intermittent Theta-Burst Stimulation for Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry.
2. Key Potential Drug Launches in 2025. Citeline.
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033. Biospace.
4. Seromycin: Package Insert / Prescribing Information. Drugs.com.
5. Rising Healthcare Costs Leave People Behind. OncLive.