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Last Updated: July 14, 2025

CLINICAL TRIALS PROFILE FOR METHYLDOPA


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All Clinical Trials for Methyldopa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00117546 ↗ Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia Unknown status Radboud University Phase 4 2005-09-01 A history of preeclampsia is associated with a low plasma volume and higher sympathetic activity. Methyldopa will suppress sympathetic activity to normal values. In this study, the researchers will test that effect on the total cardiovascular balance.
NCT00157521 ↗ L-Arginine in Pre-Eclampsia Completed Mario Negri Institute for Pharmacological Research Phase 3 2002-09-01 Pre-eclampsia is a disorder unique to pregnancy affecting both the mother and the fetus. Hypertension, proteinuria and edema are the most common and well-known maternal clinical symptoms. The incidence is approximately 6-8%. Pre-eclampsia is one of the leading causes of maternal and fetal mortality and morbidity associated with pregnancy throughout the world. The pathophysiology is unknown. At present, the most effective treatment is immediate delivery. The researchers' studies contributed to the demonstration that the vasodilator nitric oxide (NO) is important for correct placentation and that less nitric oxide (NO)- dependent vasodilation and an excess formation of reactive oxygen species explain poor placenta perfusion in pre-eclampsia. This reduced NO activity and increased oxidative stress in pre-eclamptic placenta is related to low bioavailability of L-arginine, the NO precursor. In this pilot study the researchers want to evaluate whether the administration of L-arginine to women with a clinical diagnosis of preeclampsia might restore physiological NO production in the placenta and ameliorate the pregnancy outcome.
NCT00194974 ↗ Treatment Targets for Chronic Hypertension in Pregnancy Withdrawn Weill Medical College of Cornell University Phase 1/Phase 2 2004-07-01 This project is a clinical study of women with high blood pressure who become pregnant. Preeclampsia is a syndrome developing at the end of a pregnancy characterized by an abrupt rise in blood pressure (BP), blood clotting and kidney dysfunction, and may result in premature delivery, infant death, and maternal bleeding, kidney failure and stroke. The goal is to determine whether lowering blood pressure to a normal pressure of 120/80 is associated with a lower incidence of preeclampsia. Women who are completely healthy have a 5% chance of developing preeclampsia, however women with preexisting high blood pressure have a 25% chance of this complication. Several studies, including our own suggest that higher blood pressure early in pregnancy (<20 weeks) is associated with an even higher risk of preeclampsia. Currently we, the researchers at Weill Medical College of Cornell University, do not know how to treat women with high blood pressure and/or kidney disease during pregnancy. Keeping the BP in the normal range may be beneficial to the mother. On the other hand, we are not sure if the blood pressure lowering or the medications may or may not have adverse effects for the baby. Different trials to answer this question have been performed with no clear conclusions. Because of these uncertainties, we propose to compare two different strategies for treating women with high BP who become pregnant. We will treat half the women with BP medications to normalize BP (120-130/80 mm Hg) (experimental group) and the other half with the goal of keeping the BP slightly higher (140-150/90-100 mm Hg)(standard therapy group). We will determine which approach results in healthier pregnancies, and lower incidence of preeclampsia. Reducing the incidence of preeclampsia would be of significant benefit to both mothers and babies.
NCT00329511 ↗ A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy Withdrawn Afshan B. Hameed, M.D. N/A 2004-09-01 High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an increased risk of development of pregnancy related high BP called preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature separation of the placenta from the uterus resulting in damage to the fetus and cesarean delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes, and therefore, medications to lower BP are used for moderate to severe hypertension. To date the literature on the medications used in pregnancy is extremely limited. Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak antihypertensive medicine given three or four times a day and frequently needs changes in the dose or may require an additional medication to control BP. This may lead to a greater chance of non compliance. Another option is Clonidine which is an effective antihypertensive treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects. Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be released and absorbed transdermally over a 7-day period. The study will determine differences in compliance between the two antihypertensive regimens- oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and adequacy of BP control, as well as provide information on an alternate option for BP control.
NCT00329511 ↗ A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy Withdrawn University of California, Irvine N/A 2004-09-01 High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an increased risk of development of pregnancy related high BP called preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature separation of the placenta from the uterus resulting in damage to the fetus and cesarean delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes, and therefore, medications to lower BP are used for moderate to severe hypertension. To date the literature on the medications used in pregnancy is extremely limited. Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak antihypertensive medicine given three or four times a day and frequently needs changes in the dose or may require an additional medication to control BP. This may lead to a greater chance of non compliance. Another option is Clonidine which is an effective antihypertensive treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects. Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be released and absorbed transdermally over a 7-day period. The study will determine differences in compliance between the two antihypertensive regimens- oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and adequacy of BP control, as well as provide information on an alternate option for BP control.
NCT00580619 ↗ Autonomic Nervous System and Chronic Fatigue Syndrome Completed Vanderbilt University Phase 1 2007-04-01 The investigators propose to test the hypothesis that the sympathetic nervous system contributes to the cardiovascular and inflammatory abnormalities present in the chronic fatigue syndrome (CFS) and, in particular in the subset of patients characterized by postural tachycardia syndrome (POTS). CFS and POTS are seen mostly in otherwise normal young women, and are the cause of significant disability. A substantial proportion of patients referred for evaluation of POTS met diagnostic criteria for CFS and, conversely, a subset of patients referred for treatment for CFS have POTS. The investigators hypothesize that sympathetic activation underlies the pathophysiology of patients in whom CFS and POTS overlap (CFS-P).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Methyldopa

Condition Name

Condition Name for Methyldopa
Intervention Trials
Preeclampsia 4
Pre-Eclampsia 3
Hypertension 2
Hypertension in Pregnancy 2
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Condition MeSH

Condition MeSH for Methyldopa
Intervention Trials
Pre-Eclampsia 12
Hypertension, Pregnancy-Induced 6
Hypertension 6
Eclampsia 4
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Clinical Trial Locations for Methyldopa

Trials by Country

Trials by Country for Methyldopa
Location Trials
United States 5
Brazil 3
India 2
Netherlands 2
Nigeria 1
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Trials by US State

Trials by US State for Methyldopa
Location Trials
New York 2
Colorado 1
Tennessee 1
California 1
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Clinical Trial Progress for Methyldopa

Clinical Trial Phase

Clinical Trial Phase for Methyldopa
Clinical Trial Phase Trials
Phase 4 7
Phase 3 1
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Methyldopa
Clinical Trial Phase Trials
Completed 9
Withdrawn 3
Not yet recruiting 2
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Clinical Trial Sponsors for Methyldopa

Sponsor Name

Sponsor Name for Methyldopa
Sponsor Trials
Bill and Melinda Gates Foundation 2
University of British Columbia 2
Mario Negri Institute for Pharmacological Research 1
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Sponsor Type

Sponsor Type for Methyldopa
Sponsor Trials
Other 30
Industry 3
NIH 1
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Methyldopa: Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction to Methyldopa

Methyldopa, a centrally-acting alpha-2 adrenergic agonist, has been a staple in the management of hypertension since its introduction in 1960. It is used both as monotherapy and in combination with other medications, such as hydrochlorothiazide, to treat high blood pressure and hypertensive crises.

Clinical Trials Update

Current Status and Phases

Methyldopa has undergone various clinical trials across different phases. Here is a summary of its current clinical trial status:

  • Phase 0: No trials are currently listed in this phase.
  • Phase 1: There have been five Phase 1 trials, focusing on the safety and pharmacokinetics of methyldopa.
  • Phase 2: Three Phase 2 trials have been conducted to evaluate the efficacy and side effects of methyldopa in different patient populations.
  • Phase 3: No Phase 3 trials are currently listed, indicating that the primary efficacy and safety data have already been established.
  • Phase 4: Six Phase 4 trials are ongoing or have been completed, primarily focusing on post-marketing surveillance, long-term efficacy, and safety in various patient groups[1].

New Potential Uses

Recent research has explored methyldopa's potential in preventing and treating type 1 diabetes. A study published in The Journal of Clinical Investigation found that methyldopa could inhibit the DQ8 molecule, which is linked to the onset of type 1 diabetes. This study, although in its early stages, suggests significant implications for the prevention and treatment of type 1 diabetes and possibly other autoimmune diseases[4].

Market Analysis

Market Size and Growth

The alpha (α) methyldopa market has seen rapid growth in recent years, driven by several key factors:

  • Historic Growth: The market size grew from $9.31 billion in 2023 to a projected $10.24 billion in 2024, with a compound annual growth rate (CAGR) of 10%[2][3].
  • Forecasted Growth: The market is expected to reach $15.14 billion by 2028, with a CAGR of 10.3% during the forecast period. This growth is attributed to improvements in diagnostic techniques, public health campaigns, increased research funding, and the development of healthcare infrastructure[2][3].

Market Drivers

Several factors are driving the growth of the methyldopa market:

  • Increasing Awareness and Management of Hypertension: Growing awareness about hypertension and the focus on managing chronic diseases are significant drivers.
  • Aging Population and Rising Obesity Rates: An aging population and rising rates of obesity contribute to the increasing prevalence of hypertension, thereby driving demand for methyldopa[2][3].
  • Preference for Generic Drugs: The growing preference for generic medications, which are cost-effective and offer equivalent quality and safety, also bolsters the market. Generic versions of methyldopa are particularly beneficial for groups such as pregnant women[3].
  • Healthcare Expenditure: Increasing global healthcare expenditure, driven by aging populations and higher incidence of chronic diseases, further supports the market growth[3].

Market Segmentation

The methyldopa market can be segmented by type, application, and region:

  • Type: Oral and intravenous forms are the primary types, with varying purities (e.g., =98% and =99%)[2].
  • Application: Methyldopa is used primarily for managing hypertension and hypertensive crises. Emerging applications include the potential prevention and treatment of type 1 diabetes[1][4].
  • Region: The market is split across various regions, with significant growth expected in countries with high prevalence rates of hypertension and increasing healthcare expenditure[2][3].

Projections and Future Trends

Market Projections

The methyldopa market is projected to continue its rapid growth due to several factors:

  • Diagnostic Improvements: Advancements in diagnostic techniques will help in early detection and management of hypertension.
  • Public Health Campaigns: Expanded public health campaigns will increase awareness and drive demand for antihypertensive medications.
  • Healthcare Infrastructure: Development of healthcare infrastructure, especially in emerging markets, will support the growth of the methyldopa market[2][3].

Future Trends

Several trends are expected to shape the future of the methyldopa market:

  • Advancements in Drug Delivery Systems: Innovations in drug delivery systems will enhance the efficacy and patient compliance of methyldopa.
  • Integration of Digital Health Solutions: The integration of digital health solutions and the application of artificial intelligence in healthcare will improve the management and monitoring of hypertension[2][3].
  • Biopharmaceutical Innovations: Developments in biopharmaceuticals and clinical trial methodologies will further optimize the use of methyldopa and potentially expand its applications[2][3].

Key Players in the Methyldopa API Market

The active pharmaceutical ingredient (API) market for methyldopa involves several key players:

  • Wild Wind Pharmaceutical
  • Yongtai Technology
  • Joshi Agrochem Pharma
  • Dr.Reddy's Lab
  • Hangzhou Qiantai Biotechnology Co., Ltd.

These companies are expected to play a significant role in the production and supply of methyldopa API, contributing to the market's growth[5].

Conclusion

Methyldopa remains a crucial medication in the management of hypertension, with a growing market driven by increasing awareness, advancements in healthcare, and the preference for generic medications. As research continues to explore new potential uses, such as the prevention and treatment of type 1 diabetes, the future of methyldopa looks promising.

Key Takeaways

  • Clinical Trials: Methyldopa has undergone various clinical trials, with ongoing Phase 4 trials and new potential uses being explored.
  • Market Growth: The market is expected to grow from $9.31 billion in 2023 to $15.14 billion by 2028, driven by several key factors.
  • Market Drivers: Increasing awareness of hypertension, an aging population, rising obesity rates, and the preference for generic drugs are significant drivers.
  • Future Trends: Advancements in drug delivery systems, integration of digital health solutions, and biopharmaceutical innovations will shape the future of the methyldopa market.

FAQs

  1. What is methyldopa primarily used for?

    • Methyldopa is primarily used to manage hypertension and treat hypertensive crises.
  2. What are the main mechanisms of action of methyldopa?

    • Methyldopa acts as an agonist at alpha-2 adrenergic receptors and inhibits the aromatic L-amino acid decarboxylase enzyme, regulating sympathetic outflow and reducing blood pressure[1].
  3. What is the projected market size of the methyldopa market by 2028?

    • The methyldopa market is expected to reach $15.14 billion by 2028, with a CAGR of 10.3% during the forecast period[2][3].
  4. Which companies are key players in the methyldopa API market?

    • Key players include Wild Wind Pharmaceutical, Yongtai Technology, Joshi Agrochem Pharma, Dr.Reddy's Lab, and Hangzhou Qiantai Biotechnology Co., Ltd.[5].
  5. Is methyldopa being explored for other medical conditions?

    • Yes, methyldopa is being explored for the prevention and treatment of type 1 diabetes due to its potential to inhibit the DQ8 molecule linked to the onset of the disease[4].

Sources

  1. DrugBank: Methyldopa: Uses, Interactions, Mechanism of Action.
  2. Research and Markets: Alpha (a) Methyldopa Market Report 2024.
  3. GII Research: Alpha (a) Methyldopa Global Market Report 2024.
  4. Medical News Today: Common blood pressure drug may prevent type 1 diabetes.
  5. Valuates Reports: Methyldopa API - Market, Report Size, Worth, Revenue, Growth.

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