Attention Deficit Hyperactivity Disorder Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, ROA, and Companies by DelveInsight
(Albany, USA) DelveInsight's " Attention Deficit Hyperactivity Disorder Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Attention Deficit Hyperactivity Disorder market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations.
For emerging Attention Deficit Hyperactivity Disorder drugs, the Attention Deficit Hyperactivity Disorder pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies.
Download DelveInsight's comprehensive report to uncover breakthrough therapies, clinical progress, and future market opportunities @ Attention Deficit Hyperactivity Disorder Pipeline Outlook
Key Takeaways from the Attention Deficit Hyperactivity Disorder Pipeline Report
DelveInsight's Attention Deficit Hyperactivity Disorder Pipeline analysis depicts a robust space with 20+ active players working to develop 22+ pipeline drugs for Attention Deficit Hyperactivity Disorder treatment.
The leading Attention Deficit Hyperactivity Disorder companies include Cingulate Therapeutics, Otsuka Pharmaceutical, BioLite, Mind Medicine, Tris Pharma, RespireRx Pharmaceuticals, KemPharm, Arbor Pharmaceuticals, Ensysce Biosciences, 3Z Pharmaceuticals, Shire, Takeda, New River Pharmaceuticals, Aevi Genomic Medicine LLC, Sumitomo Pharma America Inc., Orient Pharma Co. Ltd., Durect, Rhodes Pharmaceuticals L.P., Purdue Pharma LP, CoMentis, Johnson & Johnson Ltd., Xian-Janssen Pharmaceutical Ltd., Shionogi Inc., Pfizer, Novartis, Neos Therapeutics Inc., Janssen Pharmaceuticals, and others are evaluating their lead assets to improve the Attention Deficit Hyperactivity Disorder treatment landscape.
Key Attention Deficit Hyperactivity Disorder pipeline therapies in various stages of development include CTx-1301, Centanafadine, PDC-1421, and others.
In January 2025, generic drugmaker Granules received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate Capsules, a medication for Attention Deficit Hyperactivity Disorder (ADHD), available in multiple strengths.
In December 2024, Granules India received FDA approval for Lisdexamfetamine Dimesylate chewable tablets, its generic version of Takeda Pharmaceuticals' Vyvanse. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and moderate to severe binge eating disorder (BED).
Request a sample and discover the recent breakthroughs happening in the Attention Deficit Hyperactivity Disorder pipeline landscape @ Attention Deficit Hyperactivity Disorder Treatment Drugs
Attention Deficit Hyperactivity Disorder Overview
ADHD is a neurodevelopmental disorder that significantly impacts a child's ability to function, characterized by persistent patterns of inattention, hyperactivity, and impulsivity. Previously classified as separate conditions-Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder-the DSM-IV merged them into a single diagnosis with three subtypes: predominantly inattentive, predominantly hyperactive, and combined type.
Symptoms typically emerge in early childhood and include difficulty focusing, disorganization, forgetfulness, and trouble completing tasks. For a diagnosis, these symptoms must appear before age 12, persist for at least six months, and disrupt daily life across multiple settings, such as home and school. ADHD can affect social interactions, academic performance, and even increase the likelihood of risky behaviors and job instability.
As a disorder linked to executive dysfunction, ADHD primarily affects the frontal lobe, impairing attention, decision-making, and emotional regulation. Children with ADHD may struggle with frustration, impulsivity, and social interactions, often being misperceived as troublemakers. Brain abnormalities, including reduced size in the anterior cingulate gyrus and dorsolateral prefrontal cortex (DLPFC), contribute to deficits in goal-directed behavior, with decreased activity in the frontostriatal region observed through fMRI scans.
The exact cause of ADHD remains unclear but involves both genetic and environmental influences. It is one of the most heritable psychiatric disorders, with higher concordance in identical twins and an increased risk among siblings. Environmental factors such as prenatal exposure to smoking, alcohol, nutritional deficiencies, and viral infections have also been linked to its development. Research suggests that lower dopamine receptor availability in the frontal lobes and noradrenergic system involvement may play a role in the disorder's pathology.
Find out more about Attention Deficit Hyperactivity Disorder medication @ ADHD Medication and Companies
Attention Deficit Hyperactivity Disorder Treatment Analysis: Drug Profile
CTx-1301: Cingulate Therapeutics
CTx-1301 leverages Cingulate's Precision Timed Release (PTR) technology to develop an advanced multi-core dexmethylphenidate formulation for ADHD treatment. This innovative tablet integrates immediate and sustained release layers, ensuring precise drug delivery throughout the day. Designed for rapid onset, full-day efficacy, and a controlled decline in plasma levels, CTx-1301 aims to optimize symptom management. Currently, the drug is in Phase III clinical trials for ADHD.
Centanafadine: Otsuka Pharmaceutical
Centanafadine, a triple-reuptake inhibitor targeting serotonin, norepinephrine, and dopamine, was initially developed by Neurovance before Otsuka Pharmaceutical acquired its rights in 2017. Two Phase III trials, involving approximately 900 adults (ages 18-55) with ADHD, assessed its efficacy through randomized, double-blind, placebo-controlled studies. Participants received either 100 mg or 200 mg doses twice daily, or a placebo. Centanafadine demonstrated significant symptom improvements compared to placebo across primary and key secondary endpoints. Safety data from both studies indicated no adverse events affecting more than 7% of participants.
Key Attention Deficit Hyperactivity Disorder Therapies and Companies
Attention Deficit Hyperactivity Disorder Therapeutics Assessment
By Product Type
Mono
Combination
Mono/Combination.
By Stage
Late-stage products (Phase III)
Mid-stage products (Phase II)
Early-stage product (Phase I) along with the details of
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
By Route of Administration
Oral
Intravenous
Subcutaneous
Parenteral
Topical
By Molecule Type
Recombinant fusion proteins
Small molecule
Monoclonal antibody
Peptide
Polymer
Gene therapy
Scope of the Attention Deficit Hyperactivity Disorder Pipeline Report
Coverage: Global
Key Attention Deficit Hyperactivity Disorder Companies: Cingulate Therapeutics, Otsuka Pharmaceutical, BioLite, Mind Medicine, Tris Pharma, RespireRx Pharmaceuticals, KemPharm, Arbor Pharmaceuticals, Ensysce Biosciences, 3Z Pharmaceuticals, Shire, Takeda, New River Pharmaceuticals, Aevi Genomic Medicine LLC, Sumitomo Pharma America Inc., Orient Pharma Co. Ltd., Durect, Rhodes Pharmaceuticals L.P., Purdue Pharma LP, CoMentis, Johnson & Johnson Ltd., Xian-Janssen Pharmaceutical Ltd., Shionogi Inc., Pfizer, Novartis, Neos Therapeutics Inc., Janssen Pharmaceuticals, and others.
Key Attention Deficit Hyperactivity Disorder Pipeline Therapies: CTx-1301, Centanafadine, PDC-1421, and others.
Dive deep into rich insights for drugs used for Attention Deficit Hyperactivity Disorder treatment; visit @ Attention Deficit Hyperactivity Disorder FDA Approvals and Recent Development
Table of Contents
1. Introduction
2. Executive Summary
3. Attention Deficit Hyperactivity Disorder Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Attention Deficit Hyperactivity Disorder Pipeline Therapeutics
6. Attention Deficit Hyperactivity Disorder Pipeline: Late-Stage Products (Phase III)
7. Attention Deficit Hyperactivity Disorder Pipeline: Late-Stage Products (Phase III)
8. Attention Deficit Hyperactivity Disorder Pipeline: Mid-Stage Products (Phase II)
9. Attention Deficit Hyperactivity Disorder Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CTV News
34 minutes ago
- CTV News
The real Paleo diet: Neanderthals dined on rotten meat and maggots, study suggests
Lead author Melanie Beasley captured this image of a "maggot mass" for a follow-up study related to the newly released paper. (Melanie Beasley via CNN Newsource) Neanderthals had a voracious appetite for meat. They hunted big game and chowed down on woolly mammoth steak as they huddled around a fire. Or so thought many archaeologists who study the Stone Age. Fresh meat was far from the only thing on the menu, according to a growing body of research that has revealed our archaic cousins ate a varied diet that included pulses and shellfish. Still, a chemical signature in Neanderthal remains that suggests robust meat eating — observed at higher levels than those seen in top predators such as lions and wolves — has puzzled researchers for decades. Now, new research hints at an unexpected Stone Age food. Maggots — the larvae of flies, which hatch in and feed on decaying animal tissue — may also have been a staple of prehistoric diets, a study published Friday in the journal Science Advances suggests. Lead author Melanie Beasley, an assistant professor of biological anthropology at Purdue University in West Lafayette, Indiana, found that a taste for maggots could explain a distinctive chemical signature detected in the bones of prehistoric humans, including Homo sapiens and Neanderthals, a species that went extinct 40,000 years ago. The findings back up a hypothesis that had been put forward by Beasley's coauthor John Speth, an anthropologist at the University of Michigan, who has for nearly a decade argued that putrid meat and fish would have formed a key part of prehistoric diets. His work was based on ethnographic accounts of the diets of indigenous groups, who he said found rotten meat and maggots acceptable fare. 'Not a lot of people took notice, because it was like this is an out-there idea. And there wasn't any data,' said Beasley, who heard Speth give a talk in 2017 and subsequently decided to test his hypothesis. Understanding past diets To understand past diets and where an animal sat in the ancient food chain, scientists study the chemical signature of different isotopes, or variants, of elements such as nitrogen or carbon, which are preserved in teeth and bones over thousands of years. Researchers first found in the 1990s that the fossilized bones of Neanderthals unearthed in Northern Europe had particularly elevated levels of the nitrogen-15 isotope, a chemical signature that suggests their meat consumption was on par with hypercarnivores such as lions or wolves. 'Grass will have one (nitrogen) value, but then the deer that eats the grass is going to have a higher value, and then the carnivore that eats the deer is going to have an even higher value,' Beasley explained. 'So you can track nitrogen through this trophic food web system.' Neanderthal remains, she said, had even higher nitrogen values than carnivores. This was puzzling, however, because modern-day humans, unlike wolves and lions, cannot stomach large quantities of lean meat. Overindulging in it can lead to a potentially lethal form of malnutrition in which the liver fails to break down the protein and rid the body of excess nitrogen. Known today as protein poisoning, the condition was more common among European explorers of North America — who dubbed the illness 'rabbit poisoning' or 'mal de caribou' — given that wild game was far leaner than today's farmed meat. Archaeologists believe that Neanderthals understood the importance of fatty nutrients, and, at least in one location in what's now Germany, processed animal bones on a large scale to extract the fat. Rotten meat might be higher in nitrogen than fresh tissue and may have been responsible for boosting nitrogen levels in Neanderthal bones, Speth's research has suggested. Not long after hearing Speth speak, Beasley, who was previously a postdoctoral fellow at the University of Tennessee, Knoxville, where she conducted research at its Forensic Anthropology Center, decided to investigate. The research facility, sometimes described as a body farm, was established to study how the human body decomposes. There, she analyzed nitrogen levels in the rotting tissue of donated human corpses left outdoors and the fly larvae that formed in the muscle tissue. The work, conducted over a two-year period, required a strong stomach, she said. Beasley found that nitrogen levels increased modestly over time in the human tissue. However, she observed much higher nitrogen levels in the fly larvae, suggesting that Neanderthals and early modern humans likely consumed animal meat laced with maggots on a regular basis. 'I started getting the (nitrogen) values back, and they were just astronomically high,' Beasley recalled. 'John (Speth) and I started talking: What if it's not just the putrid meat, but it's the fact that … they're never going to be able to prevent flies from coming and landing on the meat, and so fly larva just become part of the delicacy,' she said. The data from her work not only provides insight into the Neanderthal diet but also informs modern forensic science, with nitrogen levels in maggots that form in human corpses helping scientists pinpoint time since death, she noted. 'No brainer' It was a 'no brainer' that Neanderthals ate maggots, said Karen Hardy, a professor of prehistoric archaeology at the University of Glasgow in Scotland. Hardy, who wasn't involved in the study, said the authors provided a 'strong argument in favor of maggot consumption,' although such behavior is unlikely to be conclusively proven because maggot remains do not survive in the archaeological record. 'The surprise element is more to do with our Western perspective on what is edible and what is not,' she added. Today, at least 2 billion people worldwide are estimated to consume insects as part of traditional diets, according to the United Nations Food and Agriculture Organization. The study also noted that, according to historical accounts, many indigenous peoples such as the Inuit 'viewed thoroughly putrefied, maggot-infested animal foods as highly desirable fare, not starvation rations.' Many such groups, according to the study, 'routinely, often intentionally, allowed animal foods to decompose to the point where they were crawling with maggots, in some cases even beginning to liquify, and inevitably emitting a stench so overpowering that early European explorers, fur trappers, and missionaries were sickened by it.' Knud Rasmussen, a polar explorer from Greenland, recorded the following culinary experience, cited in the study, in his 1931 book 'The Netsilik Eskimos: Social Life and Spiritual Culture.' 'The meat was green with age, and when we made a cut in it, it was like the bursting of a boil, so full of great white maggots was it. To my horror my companions scooped out handfuls of the crawling things and ate them with evident relish. I criticised their taste, but they … said, not illogically: 'You yourself like caribou meat, and what are these maggots but live caribou meat? They taste just the same as the meat and are refreshing to the mouth.' The study also noted that maggots are not unknown in Western culinary traditions, noting the Sardinian cheese casu marzu is replete with the larvae of cheese skipper flies. Beasley said that Northern latitude groups still process these foods today and consume them safely when prepared following traditional practices. Limitations Beasley's research on modern-day corpses was exploratory and had several limitations, she cautioned. The work, which involved small sample sizes, focused on human muscle tissue, not the tissue or organs of animals that might have been hunted by Neanderthals. What's more, the fly larvae, which came from three different families, might have differed from those that existed in the late Pleistocene, which ended around 11,000 years ago. The study also didn't account for the wide variety of climates and temperatures that would have had an effect on stored meat in the Stone Age. She also added that the human body tissue wasn't cooked, processed or prepared in any way. Beasley has spoken with researchers in Alaska in the hopes of connecting with native groups that would be interested in sharing traditional food preparations. Her goal is to better understand how that might affect the nitrogen level. The new research has 'opened a fascinating line of inquiry' into the culinary practices of Stone Age hunter-gatherers such as Neanderthals, said Wil Roebroeks, professor emeritus of paleolithic archaeology at Leiden University in the Netherlands. He wasn't involved in the research. 'It certainly gives a fresh — if that is the right word here — perspective on Neanderthal and other Late Pleistocene humans' diets,' Roebroeks added.
CTV News
2 hours ago
- CTV News
Are you overdoing it on electrolytes? Quebec poison control says calls are on the rise
Electrolyte drinks may quench your thirst on a hot day or after a gruelling workout, but Quebec's poison control centre is warning they're not without risks. Centre antipoison du Québec is reporting a sharp increase in exposure cases related to electrolyte supplements. The number of reported cases has increased by 30 per cent in the province over the past four years. According to data from the centre, cases involving electrolyte and mineral supplements increased to 763 as of 2024, up from 584 in 2020. Children under the age of five make up a significant portion of calls received by the centre, rising to 121 cases last year from 89 in 2020. Dr. Josh Wang, a toxicologist at the poison control centre and incoming president of the Canadian Association for Clinical Toxicology and Poison Centres, said the reason for the uptick is still unclear. 'It's hard to speculate. The numbers certainly show an increase in reporting to the poison centres,' said Wang, who also works as an emergency room physician at the McGill University Health Centre (MUHC). 'It's not clear to me from the data that we have what the reason is, however.' Generally safe, but don't overdo it While many products, including well-known brands like Gatorade and Pedialyte, are generally safe, Wang said problems can occur when people overdo it or take them without proper guidance. 'As an emergency physician, I frequently advise patients who are dehydrated to take these,' he said. 'But when [people] take it upon themselves to take supplementation, it's important to know what their medical problems are, and perhaps [seek] counsel from a pharmacist or doctor if there's any doubt in terms of the safety, for overdose or interactions.' He mentioned that one popular hydration drink, Prime, contains 700 milligrams of potassium, 'the same as two bananas.' That could pose a risk for people with kidney issues. 'If [people] have kidney problems, difficulty eliminating, extra potassium in their diet or from beverages could be potentially a risk,' he said. So, if you feel parched, should you choose an electrolyte drink or stick to the old standby — water? Wang assured that most products are safe when used as directed, but said to keep it simple. 'Generally, if you're thirsty, you should drink water. I think that's a good rule of thumb,' he said. If you opt for electrolyte drinks, he noted that 'it's easy to go over, make arithmetic errors, and too much of a good thing can be a bad thing.' Symptoms depend on the mineral Symptoms of overdoing it vary depending on the mineral. 'Some of them can cause diarrhea, nausea, vomiting. In more extreme cases, they can cause decreased mental status,' Wang said, pointing to magnesium. 'Calcium... can be associated with constipation.' Potassium, he said, is 'my most respected electrolyte in terms of overdose risk, danger for cardiac disturbances and dangerous cardiac rhythms that could lead the patient to present to the emergency department.' Advice for parents He also urged parents to keep all supplements safely stored away. 'Keeping supplements and medications out of lock and key, away from the reach and away from the curious eyes and fingers of little ones,' he said. 'I continue to encourage it to all my patients and all the people that ask me about it.' Wang said the Quebec poison centre is a great resource, and when in doubt, people can call the team at 1-800-463-5060. 'Specifically, in regard to overdose, we provide very efficient, very rapid advice,' he said.
CTV News
6 hours ago
- CTV News
B.C. biker clubhouse to become centre for addiction, mental health recovery
A former clubhouse for biker gangs on Vancouver Island is being transformed into a wellness centre. A building in Langford, B.C., once occupied by biker gangs is being transformed into a wellness centre for people recovering from addiction and mental illness. The building was previously used by the Savages Motorcycle Club, and before that, the Devil's Army — both of which police say are tied to the Hells Angels. The clubhouse went on the market last year, after it was raided by police during a drug trafficking and organized crime investigation. About two weeks ago, the Construction Federation of BC (CFBC) bought the property for $1.1 million. '(We're) basically taking the building from notorious to glorious,' said CFBC executive director Abigail Fulton. CFBC is a charity dedicated to supporting people in the construction industry. It plans on turning the space into a wellness hub for tradespeople, called The Forge. 'The building becomes a refuge, a place of hope and wellness for the community,' Fulton said. CFBC needs to fundraise $500,000 to refurbish the building and expand its footprint, she said. It's anticipated renovations will be completed by next summer. 'It's been a couple of decades where the neighbors have been pretty disappointed about the things that were happening at this facility, and now we get to change that script,' said CFBC philanthropy director Mike Manhas. Once the centre opens, the plan is to offer peer support, clinical counsellors, recovery coaching, and a social club. The Forge's services will not include treatment beds or harm reduction services. 'People get sent to treatment, get released, go back into the community and large numbers relapse,' Manhas said. 'When you've gone through the harm reduction piece — (and) there are lots of people providing those services — our job is to provide that recovery piece that no one's providing.' Manhas will help run the centre's programs, alongside carpenter and CFBC industry relations manager Trevor Bodkin. Both men are in recovery. 'The idea being that we take workers like myself with lived experience not only on the tools … but we train them in actually how to use their lived experience of mental health and substance use challenges and recovery to support other workers,' Bodkin said. The Forge team is hosting a ground breaking ceremony next Thursday.
