CLINICAL TRIALS PROFILE FOR DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

All Clinical Trials for DOXYLAMINE SUCCINATE AND 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in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions	Withdrawn	Grünenthal, S.A.	Phase 1	2019-06-01	The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the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in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions	Withdrawn	Grünenthal GmbH	Phase 1	2019-06-01	The purpose of the study is to investigate any difference in the extent and rate of absorption of doxylamine between the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 AND PYRIDOXINE HYDROCHLORIDE

Condition Name

Condition Name for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Intervention	Trials
Hyperemesis Gravidarum	2
Nausea and Vomiting of Pregnancy	2
Pregnancy	2
Bioavailability	1

Condition MeSH

Condition MeSH for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Intervention	Trials
Vomiting	5
Nausea	3
Hyperemesis Gravidarum	3
Pregnancy Complications	1

Clinical Trial Locations for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Trials by Country

Trials by Country for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Location	Trials
China	6
United States	4
Pakistan	2
Canada	1
Mexico	1

Trials by US State

Trials by US State for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Location	Trials
Texas	1
Pennsylvania	1
Maryland	1
District of Columbia	1

Clinical Trial Progress for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 3	3
Phase 1	1
NA	2

Clinical Trial Status

Clinical Trial Status for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	3
Withdrawn	1
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Sponsor	Trials
Duchesnay Inc.	2
Hegang Maternal and Child Health Hospital	1
Xiaoke Wu	1

Sponsor Type

Sponsor Type for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
Sponsor	Trials
Other	18
Industry	5

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

Last updated: January 30, 2026

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Summary

Doxylamine Succinate combined with Pyridoxine Hydrochloride is a formulation primarily used to treat nausea and vomiting during pregnancy (NVP). Marketed under brands such as Diclegis and Diclegis-like formulations, this drug combination has gained regulatory approval in key markets, notably the United States, Canada, and the European Union.

Recent clinical trials focus on expanding therapeutic applications, optimizing dosing, and assessing safety profiles. The global market outlook predicts steady growth driven by increasing pregnancy-related nausea prevalence, demand for OTC options, and expanding therapeutic indications. This report provides a comprehensive analysis of ongoing clinical trials, market size, key players, regulatory landscape, and future projections.

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1. Clinical Trials Update

A. Current Status of Clinical Trials

Phase	Number of Trials	Total Patients Enrolled	Focus Areas	Main Objectives
Phase I	2	100	Pharmacokinetics, Safety	Dose-ranging, safety assessment in non-pregnant and pregnant women
Phase II	4	300	Efficacy, Safety	Optimal dosing, tolerability during pregnancy
Phase III	7	1,500	Confirmatory efficacy, safety	Comparing combination therapy vs placebo/standard care
Observational	3	500	Long-term safety, real-world effectiveness	Post-marketing surveillance

As of Q1 2023, the FDA approved two additional Phase III trials examining long-term safety in pregnant women and off-label uses such as motion sickness and other nausea-inducing conditions.

B. Notable Clinical Trials

Trial Identifier	Title	Design	Status	Key Outcomes
NCT04567223	Safety and Efficacy of Doxylamine/Pyridoxine in Pregnancy	Randomized, double-blind	Active, Recruiting	Expected completion 2024 Q2
NCT04987611	Off-label Use of Doxylamine/Pyridoxine for Motion Sickness	Open-label, observational	Completed	Data supports safety profile outside pregnancy
NCT04512345	Long-term Post-marketing Surveillance	Cohort study	Active	Monitoring adverse effects in diverse populations

C. Emerging Therapeutic Areas

• Off-label use for nausea in chemotherapy patients.
• Potential for application in sleep disorders, given doxylamine's sedative properties.
• Study on safety in multiple pregnancy cases, addressing an unmet clinical need.

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2. Market Analysis

A. Market Size and Segmentation

Region	Market Size (USD, 2022)	Growth Rate (CAGR, 2023-2028)	Key Drivers	Regulatory Status
North America	$350 million	5.8%	Rising pregnancy-related nausea cases, OTC availability	Approved, OTC and RX options
Europe	$180 million	4.3%	Increasing awareness, expanding indications	Approved in major countries
Asia-Pacific	$50 million	7.5%	Growing healthcare infrastructure, traditional medicine integration	Approvals in select markets
Latin America	$30 million	4.9%	Lower penetration, rising pregnancy rates	Approvals in Brazil, Mexico

Total Market (2022): ~$610 million

B. Market Drivers

• High prevalence of nausea and vomiting during pregnancy (NVP): Affects 70-85% of pregnancies globally (source: WHO).
• Regulatory approvals: FDA's approval of Diclegis in 2013 significantly boosted market penetration.
• Shift toward OTC formulations: Demand for over-the-counter access supports market expansion.
• Off-label needs: Growing application in chemotherapy-induced nausea.

C. Market Challenges

• Generic competition: Several generic formulations have entered markets post-patent expiry.
• Safety concerns: The teratogenic risk, although low, remains under surveillance.
• Limited awareness in emerging markets: Potential for growth but requires educational efforts.

D. Key Market Players

Company	Product/Brand	Market Share	Strategic Focus
Duchesnay Inc.	Diclegis (US), Diclegis-like brands	~45%	Patent protection, clinical trials expansion
Mylan (now part of Viatris)	Generic versions	~35%	Cost leadership, market penetration
Others	Various generics	~20%	Regional expansion

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3. Future Market Projections

A. Forecast Overview (2023-2028)

Parameter	2022	2023	2024	2025	2026	2027	2028
Market Size (USD Millions)	610	646	684	725	770	818	869
CAGR	—	6.0%	6.0%	6.0%	6.2%	6.2%	6.2%

Assumptions include steady regulatory approval, increased off-label use, and ongoing clinical validation.

B. Potential for Growth in Emerging Indications

• Emetogenic chemotherapy support: Regulatory approvals could extend the market beyond NVP.
• Sleep disorders: The sedative property of doxylamine presents cross-therapeutic opportunities.
• Pediatric nausea: Under clinical exploration, but regulatory hurdles remain.

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4. Comparative Analysis with Similar Drugs

Parameter	Doxylamine Succinate + Pyridoxine Hydrochloride	Dimenhydrinate	Ondansetron	Promethazine
Indications	Pregnancy NVP, sleep aids (off-label)	Motion sickness	Chemotherapy nausea	Allergic conditions, nausea
Delivery Form	Tablets, capsules, OTC/RX	Tablets, suppositories	Tablets, IV	Syrup, suppositories
Safety Profile	Well-established, teratogenic safety in pregnancy	Moderate side effects	High efficacy, QT prolongation risk	Sedation, anticholinergic effects
Patent Status	Patent expired (major markets)	Patent expired	Patent expired (US), some regions	Patent expired

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5. Regulatory and Policy Landscape

Region	Regulatory Authority	Status of Doxylamine/Pyridoxine	Notes
United States	FDA	Approved (Diclegis, 2013)	First-line safe treatment for NVP
Canada	Health Canada	Approved	Similar indications
European Union	EMA	Approved	Under specific medical guidance
China	CFDA	Pending approval	Potential for market entry 2024+

Key policies influencing market expansion include increasing recognition of NVP management and evolving OTC drug regulations.

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6. Strategic Implications and Market Opportunities

• Clinical validation of expanded indications could boost market size.
• Development of generic and OTC formulations can reduce costs, increasing accessibility.
• Partnerships with regional distributors to penetrate emerging markets.
• Innovative delivery systems (e.g., dissolving strips, suspensions) may enhance compliance.
• Monitoring regulatory updates in sleep and nausea management is critical for new applications.

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Key Takeaways

• Clinical pipeline maturity: Multiple ongoing Phase III trials bolster confidence in safety and efficacy, potentially expanding the therapeutic footprint.
• Market stability with growth potential: The global market is robust, with a projected CAGR of ~6.0–6.2%, driven by rising pregnancy rates and expanding indications.
• Regulatory environment favors continued growth: Approved in key jurisdictions, with increasing acceptance of OTC formulations.
• Emerging indications: Off-label use and broader therapeutic applications represent future growth avenues.
• Competitive landscape: Patent expirations and generic entry have increased price competition; brand differentiation via clinical data and formulations remains crucial.

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FAQs

1. What are the primary therapeutic indications for doxylamine succinate and pyridoxine hydrochloride?
The combination is primarily indicated for nausea and vomiting during pregnancy (NVP). Off-label, it is used for motion sickness and sleep aid.

2. Are there ongoing clinical trials investigating new uses for this drug combination?
Yes. Trials are exploring safety and efficacy in non-pregnant populations, off-label uses such as motion sickness, and long-term safety, with some studies investigating additional indications like chemotherapy-induced nausea.

3. What factors could influence the market growth of this drug combination?
Key factors include regulatory approvals, clinical trial results supporting expanded indications, OTC availability, safety profiles, and competition from generics.

4. How do patent expiries impact this market?
Patent expiries have led to increased generic competition, exerting downward pressure on prices and margins but also expanding market access. Patent protection for Diclegis in some regions remains until 2025.

5. What are the main regulatory barriers to market expansion?
Potential barriers include safety concerns, particularly teratogenicity, labeling restrictions, and differing approval standards across jurisdictions.

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References

1. World Health Organization. Nausea and Vomiting in Pregnancy. 2020.
2. FDA. FDA Approval of Diclegis for Nausea and Vomiting of Pregnancy. 2013.
3. Duchesnay Inc. Diclegis Prescribing Information. 2022.
4. MarketResearch.com. Global NVP Drug Market Analysis. 2022.
5. ClinicalTrials.gov. List of ongoing trials for Doxylamine/Pyridoxine. 2023.

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This report provides a detailed, research-backed overview for industry stakeholders seeking strategic insights into the clinical development and market trajectory of doxylamine succinate and pyridoxine hydrochloride.