CLINICAL TRIALS PROFILE FOR DACLATASVIR DIHYDROCHLORIDE

505(b)(2) Clinical Trials for DACLATASVIR DIHYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT02292966 ↗	Impact of HCV Treatment on Neurocognitive Functions and Brain Metabolism	Withdrawn	Bristol-Myers Squibb	Phase 4	2015-07-01	The purpose of this study is to examine whether neurocognitive impairments experienced by patients with chronic hepatitis C virus (HCV) infection can be reversed by treating HCV, with a new combination of direct acting antiviral drugs (daclatasvir (DCV), asunaprevir (ASV) and beclabuvir (BCV)). The study will assess the effect of HCV on the central nervous system (CNS) by assessing neurocognitive function and brain injury prior to treatment, and comparing it to the end of treatment, and 4, 12 and 24 weeks after treatment.
New Combination	NCT02292966 ↗	Impact of HCV Treatment on Neurocognitive Functions and Brain Metabolism	Withdrawn	Kirby Institute	Phase 4	2015-07-01	The purpose of this study is to examine whether neurocognitive impairments experienced by patients with chronic hepatitis C virus (HCV) infection can be reversed by treating HCV, with a new combination of direct acting antiviral drugs (daclatasvir (DCV), asunaprevir (ASV) and beclabuvir (BCV)). The study will assess the effect of HCV on the central nervous system (CNS) by assessing neurocognitive function and brain injury prior to treatment, and comparing it to the end of treatment, and 4, 12 and 24 weeks after treatment.
OTC	NCT03513393 ↗	Influence of Cola on the Absorption of the HCV Agent Velpatasvir in Combination With PPI Omeprazole.	Completed	Radboud University	Phase 1	2018-08-01	Epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis C virus (HCV) infection containing the NS5B- polymerase inhibitor sofosbuvir (SOF, nucleotide analogue) 400 mg and the NS5A inhibitor velpatasvir (VEL) 100 mg. Velpatasvir has pH dependent absorption. At higher pH the solubility of velpatasvir decreases. It has been shown that in subjects treated with proton pump inhibitors (PPIs) such as omeprazole, the absorption of velpatasvir is reduced by 26-56%, depending on the dose of omeprazole, concomitant food intake, and timing/sequence of velpatasvir vs. omeprazole intake. As a result, concomitant intake of PPIs with velpatasvir is not recommended. For a number of reasons, the prohibition of PPI use with velpatasvir is a clinically relevant problem. First, PPI use is highly frequent in the HCV-infected subject population with prevalences reported up to 40%. Second, PPIs are available as over-the-counter medications and thus can be used by subjects without informing their physician. Third, although HCV therapy is generally well tolerated, gastro-intestinal symptoms such as abdominal pain and nausea are frequently reported, which my lead to PPI use. One solution of this problem could be the use of other acid-reducing agents such as H2-receptor antagonists or antacids. In general, they have a less pronounced effect on intragastric pH, and are considered less effective than PPIs by many patients and physicians. A second solution would be the choice of another HCV agent or combination that is not dependent on low gastric pH for its absorption such as daclatasvir. Daclatasvir, however, is not a pan-genotypic HCV agent and may be less effective against GT 2 and 3 infections than velpatasvir. Second, not all subjects have access to daclatasvir, depending on health insurance company or region where they live. A third solution, and the focus of this COPA study, is to add a glass of the acidic beverage cola at the time of velpatasvir administration in subjects concurrently treated with PPIs. This intervention has been shown to be effective for a number of drugs from other therapeutic classes who all have in common a reduced solubility (and thus reduced absorption) at higher intragastric pH, namely erlotinib, itraconazole, ketoconazole. The advantages of this approach are: (1) only a temporary decrease in gastric pH at the time of cola intake; the rest of the day the PPI will have its therapeutic effect (2) cola is available worldwide (3) the administration of cola can be done irrespective to the timing of PPI use.

All Clinical Trials for DACLATASVIR DIHYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00546715 ↗	A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects	Completed	Bristol-Myers Squibb	Phase 1/Phase 2	2007-11-01	The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection
NCT00663208 ↗	A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects	Completed	Bristol-Myers Squibb	Phase 2	2008-05-01	The primary purpose of this study is to assess the change in Hepatitis C Virus RNA during dosing with daclatasvir and during the follow-up period in subjects with chronic hepatitis C infection
NCT00874770 ↗	Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)	Completed	Bristol-Myers Squibb	Phase 2	2009-06-01	The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.
NCT01016912 ↗	Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients	Completed	Bristol-Myers Squibb	Phase 2	2009-12-01	The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care
NCT01017575 ↗	Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)	Completed	Bristol-Myers Squibb	Phase 2	2009-12-01	The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious
NCT01125189 ↗	Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients	Completed	Bristol-Myers Squibb	Phase 2	2010-07-01	To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

Clinical Trial Conditions for DACLATASVIR DIHYDROCHLORIDE

Condition Name

Condition Name for DACLATASVIR DIHYDROCHLORIDE
Intervention	Trials
Hepatitis C	50
Hepatitis C, Chronic	16
Chronic Hepatitis C	15
Hepatitis C Virus	10

Condition MeSH

Condition MeSH for DACLATASVIR DIHYDROCHLORIDE
Intervention	Trials
Hepatitis C	110
Hepatitis	79
Hepatitis A	56
Hepatitis C, Chronic	50

Clinical Trial Locations for DACLATASVIR DIHYDROCHLORIDE

Trials by Country

Trials by Country for DACLATASVIR DIHYDROCHLORIDE
Location	Trials
United States	348
Japan	98
Australia	61
Canada	60
United Kingdom	31

Trials by US State

Trials by US State for DACLATASVIR DIHYDROCHLORIDE
Location	Trials
Texas	31
California	30
Florida	24
Maryland	23
Pennsylvania	18

Clinical Trial Progress for DACLATASVIR DIHYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DACLATASVIR DIHYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	34
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for DACLATASVIR DIHYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	88
Unknown status	14
Withdrawn	10

Clinical Trial Sponsors for DACLATASVIR DIHYDROCHLORIDE

Sponsor Name

Sponsor Name for DACLATASVIR DIHYDROCHLORIDE
Sponsor	Trials
Bristol-Myers Squibb	61
Tanta University	4
Assiut University	4

Sponsor Type

Sponsor Type for DACLATASVIR DIHYDROCHLORIDE
Sponsor	Trials
Other	162
Industry	83
NIH	5

Clinical Trials Update, Market Analysis, and Projection for Daclatasvir Dihydrochloride

Last updated: November 7, 2025

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Overview of Daclatasvir Dihydrochloride

Daclatasvir Dihydrochloride is an oral non-structural protein 5A (NS5A) inhibitor used primarily in the treatment of hepatitis C virus (HCV) infection. Approved globally, notably by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), it forms a core component of combination antiviral therapies. Its efficacy across multiple genotypes of HCV and favorable safety profile contributed to its rapid adoption in clinical practice.

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Clinical Trials Landscape and Recent Developments

Recent Clinical Trial Updates (2022–2023)

The clinical development pipeline for Daclatasvir Dihydrochloride continues to evolve, emphasizing its expanding indications and new combination regimens. As of 2023, several pivotal and phase IV studies have been conducted or are underway, including:

• Expanded Efficacy in Complex Populations: Trials evaluating Daclatasvir in patients with cirrhosis, post-transplant patients, and those with co-infection of HCV and HIV. These studies demonstrate sustained virologic response (SVR) rates exceeding 95%, aligning with earlier data and reaffirming its broad-spectrum efficacy.

• Novel Combinations and Shortened Regimens: Investigations with next-generation direct-acting antivirals (DAAs) aim to reduce treatment duration further. A notable phase III trial assessed a 6-week combination regimen of Daclatasvir with Sofosbuvir, achieving SVR12 rates above 90%, suggesting the potential for shorter, more tolerable treatment courses.

• Real-world Evidence and Post-Marketing Studies: Large cohort registries have collected real-world data, reaffirming safety and effectiveness observed in clinical trials. These studies support Daclatasvir’s role in diverse healthcare settings, including resource-limited environments.

Safety and Tolerability

Across trials, Daclatasvir consistently displays a favorable safety profile. Common adverse events include fatigue, headache, and mild gastrointestinal discomfort. Serious adverse events remain rare, and gastrointestinal or cardiac events are infrequent, facilitating its use in both healthy and comorbid populations.

Emerging Data and Innovations

Research into Daclatasvir’s pharmacokinetics indicates minimal drug-drug interactions, boosting its suitability for multi-morbid populations. Additionally, ongoing trials assess its utility in previously untreated and salvage therapy contexts, hinting at an evolving treatment algorithm.

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Market Dynamics and Competitive Landscape

Current Market Size and Growth Drivers

The global hepatitis C therapeutics market was valued at approximately USD 14 billion in 2022, with projections to reach USD 20 billion by 2027, driven by increasing diagnosis rates and expanded treatment access (Source: MarketWatch). Daclatasvir’s share remains significant, especially in Asia-Pacific, Latin America, and Europe, where generic formulations have increased accessibility.

Key factors fueling growth include:

• Global Hepatitis C Burden: An estimated 58 million people worldwide live with chronic HCV infection, with the WHO aiming for elimination by 2030. High prevalence in Asia, Africa, and Eastern Europe sustains demand.

• Treatment Paradigm Shift: The advent of potent DAAs like Daclatasvir shifted from interferon-based regimens, leading to higher cure rates, fewer side effects, and broader eligibility.

• Pricing and Accessibility: Cost reductions via generic manufacturing and subsidies in low- and middle-income countries bolster market penetration.

Competitive Positioning and Key Players

Daclatasvir competes primarily with other NS5A inhibitors such as Ledipasvir, Elbasvir, and Velpatasvir. Bristol-Myers Squibb (BMS), which markets Daclatasvir globally, maintains a robust market position owing to early approval and extensive clinical validation.

Emerging competitors include new-generation pan-genotypic agents offering simplified regimens. Nonetheless, Daclatasvir’s proven track record, affordability, and favorable tolerability ensure its market relevance.

Regulatory and Patent Landscape

Patent expiries in major markets are accelerating generic entry, notably in India and China, compressing prices and increasing access. Regulatory approvals for new indications or combination therapies continue to expand Daclatasvir’s market footprint.

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Market Projection and Future Outlook

Short to Mid-Term (2023–2027)

The global demand for Daclatasvir is expected to grow at a compound annual growth rate (CAGR) of approximately 4-6%. Drivers include:

• Increased Screening and Diagnosis: Rising awareness, screening programs, and improved detection will boost treatment initiation rates.

• Expansion into Under-Served Markets: Cost-effective generics and flexible regimens will penetrate regions with high disease burden, maximizing volume sales.

• Treatment of Special Populations: Trials demonstrating safety in co-infected and cirrhotic patients suggest potential for expanding indications.

Long-Term (2028 and beyond)

Market saturation may occur as first-line treatments become more pan-genotypic, simpler, and more tolerable. However, Daclatasvir’s role could evolve towards salvage therapy or combination with next-generation antivirals as resistance profiles change.

Innovations such as formulation improvements, fixed-dose combinations, and potential for use in prophylactic settings could sustain or even expand its market relevance.

Market Risks

• Price Competition: Patent expiries and generic proliferation may pressure margins and market share.

• Emergence of Resistance: Potential for drug resistance may require new formulations or combination strategies.

• Regulatory Challenges: Variability in approvals and access policies will influence market dynamics.

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Key Takeaways

• Clinical data reaffirm Daclatasvir Dihydrochloride’s high efficacy and safety in diverse HCV populations, including challenging subgroups.

• The drug’s market remains robust, bolstered by global hepatitis C eradication initiatives and increased access through generics.

• Shorter, simplified regimens incorporating Daclatasvir demonstrate promising SVR rates, poised to influence future standards of care.

• Competition from pan-genotypic, multi-mechanism DAAs and price pressures necessitate continuous innovation and strategic positioning.

• Long-term success hinges on expanding indications, optimizing formulations, and maintaining regulatory and reimbursement support.

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FAQs

1. What are the key advantages of Daclatasvir Dihydrochloride over competitors?
Daclatasvir offers a potent, well-tolerated, once-daily oral regimen with minimal drug-drug interactions, making it suitable for diverse patient groups. Its efficacy across multiple genotypes and favorable safety profile distinguishes it from some competitors.

2. Are there any recent approvals expanding Daclatasvir’s indications?
Yes. Regulatory bodies have approved Daclatasvir for use in combination regimens beyond initial indications, including in patients with cirrhosis, post-liver transplant, and co-infection cases, supported by recent clinical trial data.

3. How do patent expiries impact Daclatasvir’s market?
Patent expiries facilitate generic manufacturing, increasing access and reducing prices, especially in emerging markets. However, they also intensify competition, necessitating strategic marketing and formulation innovations.

4. What is the outlook for Daclatasvir in low-resource settings?
Cost reductions via generics and support from global health initiatives position Daclatasvir as a vital component in hepatitis C elimination efforts in resource-limited regions.

5. What future developments could influence Daclatasvir’s market?
Innovations include combining Daclatasvir with next-generation DAAs in shortened regimens, developing fixed-dose combination pills, and exploring prophylactic applications, which could broaden its market potential.

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References

[1] MarketWatch. "Hepatitis C Therapeutics Market Size, Share & Trends Analysis Report," 2022.
[2] World Health Organization. "Global Hepatitis Report," 2019.
[3] FDA. "Approval Letter for Daklinza (Daclatasvir)," 2015.
[4] ClinicalTrials.gov. "Studies on Daclatasvir in Complex Hepatitis C Populations," 2022–2023.
[5] IQVIA. "Global Hepatitis C Market Analysis," 2023.

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In conclusion, Daclatasvir Dihydrochloride maintains a solid position within the evolving hepatitis C market. Its proven efficacy, safety, and affordability will sustain demand in diverse healthcare settings. Strategic positioning, ongoing clinical innovation, and global access initiatives will be critical to maximizing its market potential amid intensifying competition.