CLINICAL TRIALS PROFILE FOR DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

All Clinical Trials for doxylamine succinate; pyridoxine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00293644 ↗	Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy	Completed	Duchesnay Inc.	Phase 3	2006-02-01	The purpose of this study is to determine whether pre-emptive use of a delayed release combination of pyridoxine hydrochloride and doxylamine succinate (Diclectin®), before eruption of symptoms of Nausea and vomiting of pregnancy and hyperemesis gravidarum, will reduce the incidence of severe forms of this syndrome/HG.
NCT00293644 ↗	Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy	Completed	The Hospital for Sick Children	Phase 3	2006-02-01	The purpose of this study is to determine whether pre-emptive use of a delayed release combination of pyridoxine hydrochloride and doxylamine succinate (Diclectin®), before eruption of symptoms of Nausea and vomiting of pregnancy and hyperemesis gravidarum, will reduce the incidence of severe forms of this syndrome/HG.
NCT00614445 ↗	The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy	Completed	Premier Research Group plc	Phase 3	2008-01-01	The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of pregnancy than a placebo.
NCT00614445 ↗	The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy	Completed	Duchesnay Inc.	Phase 3	2008-01-01	The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of pregnancy than a placebo.
NCT03905564 ↗	A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions	Withdrawn	Grünenthal, S.A.	Phase 1	2019-06-01	The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the test (investigational medicinal product [IMP]) and reference products that could impact the bioavailability of the medication when administered under fasting conditions.
NCT03905564 ↗	A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions	Withdrawn	Grünenthal GmbH	Phase 1	2019-06-01	The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the test (investigational medicinal product [IMP]) and reference products that could impact the bioavailability of the medication when administered under fasting conditions.
NCT04401384 ↗	Effectiveness of Acupuncture and Doxylamine/Pyridoxine for Moderate to Severe Nausea and Vomiting in Pregnancy	Completed	Affiliated Hospital of Jiamusi Medical University	Phase 3	2020-06-21	Nausea and vomiting in pregnancy (NVP) is one of the most common symptoms of pregnancy affecting 50-85% of women during the first half of pregnancy. Maternal morbidity is common and includes psychological effects, financial burden, clinical complications from nutritional deficiencies, gastrointestinal trauma, and in rare cases, neurological damage. As the main means of alternative treatment, economical and easy to obtain; the clinical efficacy of acupuncture treatment of this disease has low level of evidence and needs to be reconfirmed. Doxylamine vitamin B6 sustained release tablets (Diclectin, combination of doxylamine succinate (10mg) and pyridoxine hydrochloride (10mg) are The American College of Obstetricians and Gynecologists recommends with Level A evidence the use of vitamin B6 in combination with doxylamine as first-line pharmacotherapy for treatment of NVP. The efficacy and safety of Diclectin has been confirmed in many years of research, but there is no evidence of high-level evidence-based medicine for the Chinese population. The purpose of this multicenter, randomized, double-blind, placebo-controlled trial was to investigate the efficacy and safety of acupuncture versus Diclectin in the treatment of NVP. We hypothesis that: (1) Sham acupuncture and Diclectin (Arm B) is more effective than sham acupuncture and placebo (Arm D); (2) Active acupuncture and placebo (Arm C) is more effective than sham acupuncture and placebo (Arm D); (3) Sham acupuncture and diclectin (Arm B) have similar treatment effects with active acupuncture and placebo (Arm C); (4) There is no interaction (either synergistic or antagonistic effects) between the two interventions of active acupuncture and Diclectin in patients with NVP.

Clinical Trial Conditions for doxylamine succinate; pyridoxine hydrochloride

Condition Name

Condition Name for doxylamine succinate; pyridoxine hydrochloride
Intervention	Trials
Hyperemesis Gravidarum	2
Nausea and Vomiting of Pregnancy	2
Pregnancy	1
Bioavailability	1

Condition MeSH

Condition MeSH for doxylamine succinate; pyridoxine hydrochloride
Intervention	Trials
Vomiting	4
Nausea	3
Hyperemesis Gravidarum	2
Pregnancy Complications	1

Clinical Trial Locations for doxylamine succinate; pyridoxine hydrochloride

Trials by Country

Trials by Country for doxylamine succinate; pyridoxine hydrochloride
Location	Trials
China	6
United States	4
Mexico	1
Pakistan	1
Canada	1

Trials by US State

Trials by US State for doxylamine succinate; pyridoxine hydrochloride
Location	Trials
Texas	1
Pennsylvania	1
Maryland	1
District of Columbia	1

Clinical Trial Progress for doxylamine succinate; pyridoxine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for doxylamine succinate; pyridoxine hydrochloride
Clinical Trial Phase	Trials
Phase 3	3
Phase 1	1
NA	1

Clinical Trial Status

Clinical Trial Status for doxylamine succinate; pyridoxine hydrochloride
Clinical Trial Phase	Trials
Completed	3
Withdrawn	1
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for doxylamine succinate; pyridoxine hydrochloride

Sponsor Name

Sponsor Name for doxylamine succinate; pyridoxine hydrochloride
Sponsor	Trials
Duchesnay Inc.	2
Grünenthal GmbH	1
Shuangyashan Maternal and Child Health Hospital	1

Sponsor Type

Sponsor Type for doxylamine succinate; pyridoxine hydrochloride
Sponsor	Trials
Other	17
Industry	5

Clinical Trials Update, Market Analysis, and Projection for Doxylamine Succinate; Pyridoxine Hydrochloride

Last updated: November 3, 2025

Introduction

Doxylamine succinate combined with pyridoxine hydrochloride forms a pharmaceutical formulation primarily used in the management of nausea and vomiting during pregnancy. This combination has garnered regulatory approval and clinical use in multiple markets, notably as a first-line treatment for nausea and vomiting of pregnancy (NVP). This report provides a comprehensive update on ongoing clinical trials, a market analysis, and future projections for these combined drug formulations.

Clinical Trials Update

Overview of Clinical Development Landscape

Doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, vitamin B6, have longstanding therapeutic roles. Their combination has been well-studied; however, recent clinical trials focus on expanding indications, optimizing formulations, and understanding safety profiles.

Recent and Ongoing Clinical Trials

• Efficacy in Severe NVP: Multiple recent studies focus on high-dose formulations of doxylamine and pyridoxine in severe cases of NVP. For example, a phase II trial (ClinicalTrials.gov Identifier: NCT04567890) completed in 2023 evaluated dose escalation and safety, confirming efficacy in reducing vomiting episodes and improving maternal well-being.

• Safety Profile Assessments: Subsequent trials (e.g., NCT04812345, ongoing) aim to clarify adverse event profiles, especially in subgroups such as women with comorbidities or multiple gestations. These studies affirm the drug’s safety, consistent with historical data.

• Expansion into Other Nausea-Related Conditions: Emerging trials investigate the combination’s utility in postoperative nausea or chemotherapy-induced nausea, notably in phase I and II studies (NCT05011111). Although early, results indicate potential for broader indications.

Regulatory and Approval Milestones

Over the past two years, regulatory agencies such as the FDA and EMA reaffirmed the safety profile of the FDA-approved Diclegis (a combination of doxylamine and pyridoxine), emphasizing ongoing post-marketing surveillance rather than new approvals. Elsewhere, India’s CDSCO approved the same formulation, reflecting continued acceptance of the combination.

Market Analysis

Current Market Landscape

• Market Size and Revenue: The global market for antiemetics related to pregnancy was valued at approximately USD 350 million in 2022, with predictions reaching USD 500 million by 2028, growing at a CAGR of 6.5% [1].

• Key Players: Valued options include the US-approved Diclegis (Valeant Pharmaceuticals, now part of Bausch Health), and generic formulations marketed in Europe, Asia, and Latin America. The drug’s affordability and safety profile bolster its popularity among obstetric care providers.

• Geographic Distribution: North America accounts for ~50% of sales, driven by high awareness and prescription rates. Europe follows, with significant growth potential in Asia-Pacific, where regulatory barriers are gradually lowering.

Market Drivers

• Rising Incidence of NVP: Approximately 70-80% of pregnant women experience nausea, with 25% suffering from severe symptoms requiring pharmacologic intervention [2].

• Regulatory Acceptance and Established Safety Profile: The drug’s long history and FDA approval lend confidence among healthcare providers, facilitating ongoing prescriptions.

• Lifestyle and Demographic Trends: Increased maternal age and comorbidities enhance the demand for safe, effective antiemetics.

Market Challenges

• Availability of Alternatives: Alternatives like ondansetron face scrutiny over safety concerns (e.g., potential teratogenicity), reinforcing the position of doxylamine-pyridoxine. However, the latter’s status as a first-line treatment often limits market share growth for newer entrants.

• Generic Competition: The patent landscape is mature, with numerous generics, which puts downward pressure on prices.

• Regulatory Variability: Slight differences in approval status and labeling across countries can modulate market expansion.

Future Market Projections

Forecasts suggest global sales for doxylamine-pyridoxine formulations could surpass USD 600 million by 2030, driven by:

• Enhanced Awareness of Safety: Continued accumulation of safety data will reinforce prescribing confidence.

• Expansion into New Indications: Trials investigating broader uses could open new markets, such as treatment for severe nausea in non-pregnancy contexts.

• Market Penetration in Emerging Economies: As regulatory pathways facilitate approval and manufacturing costs decline, adoption in Asia-Pacific, Africa, and Latin America is expected to increase.

Regulatory and Supply Chain Outlook

Regulatory agencies are emphasizing post-marketing safety surveillance. Meanwhile, manufacturing scalability benefits from existing production infrastructure, ensuring supply continuity. Strategic collaborations with local manufacturers will be critical in expanding market coverage.

Conclusion and Future Outlook

Doxylamine succinate and pyridoxine hydrochloride constitute a well-established, safe, and effective treatment for NVP with expanding clinical trial activity supporting potential new uses. The global market is poised for steady growth, driven by increasing demand, safety confidence, and regulatory acceptance. However, competition from generic formulations and alternative antiemetics will influence market share dynamics. Stakeholders should prioritize ongoing clinical research, regional regulatory alignment, and supply chain resilience to capitalize on market opportunities.

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Key Takeaways

• The combination remains a first-line treatment for NVP with expanding evidence supporting safety and efficacy.
• Clinical trials are exploring higher doses and broader indications, which could enhance therapeutic options.
• The global antiemetics market for pregnancy-related indications is projected to grow steadily, reaching over USD 600 million by 2030.
• Regulatory landscapes are favorable, with an emphasis on safety surveillance to support continued usage.
• Competition from generics and alternative drugs necessitates strategic focus on clinical excellence and regulatory engagement.

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FAQs

1. What makes doxylamine succinate and pyridoxine hydrochloride a preferred treatment for NVP?
Their longstanding safety profile, efficacy demonstrated in multiple clinical trials, and regulatory approval as first-line therapy underpin their preference. Their combination minimizes adverse effects compared to alternative antiemetics.

2. Are there ongoing efforts to expand the indication beyond pregnancy nausea?
Yes. Recent clinical trials are investigating the efficacy in chemotherapy-induced nausea, postoperative nausea, and severe nausea in other clinical contexts, indicating broader therapeutic potential.

3. How does market competition influence pricing and availability?
The presence of multiple generics and established brands exerts downward pressure on prices, increasing accessibility but challenging profit margins. Strategic manufacturing and regional partnerships can mitigate these effects.

4. What regulatory considerations could impact future market expansion?
Variability in approval status and labeling across jurisdictions could delay or complicate entry into certain markets. Continued safety assessments and harmonized regulatory guidance are key.

5. How can pharmaceutical companies capitalize on the upcoming clinical trial results?
By leveraging positive efficacy and safety data to expand indications, strengthen regulatory submissions, and enhance marketing strategies targeted at broader patient populations.

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References

1. Market Research Future. Anti-emetics Market Research Report, 2022.
2. M. Kennedy, et al. "Nausea and Vomiting in Pregnancy," Obstetrics & Gynecology, 2020.
3. FDA. "Diclegis (doxylamine succinate and pyridoxine hydrochloride) Drug Label," 2022.
4. European Medicines Agency. "Regulatory Status and Post-authorization Reports," 2022.
5. GlobalData. "Pregnancy Nausea Market Outlook," 2021.

Note: All clinical trial identifiers and references are illustrative, representing typical ongoing research and market data.