Request Demo

Last update 03 Apr 2026

Bupropion Hydrochloride

Last update 03 Apr 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryBupropion Hydrochloride, a molecule of minuscule proportions, is a drug that performs a multi-target function, with receptors and enzymes among its targets, such as the dopamine transporter (DAT), adrenergic receptor, and CYP2D6. Its main objective is that of an antidepressant, and it is chiefly utilized for treating seasonal affective disorder and depressive disorder. On December 30th, 1985, it was given approval, with GSK being the original development company. Bupropion Hydrochloride acts as a reuptake inhibitor for dopamine and norepinephrine, thereby enhancing mood elevation, while simultaneously acting as a CYP2D6 inhibitor and adrenergic receptor antagonist. While its effectiveness in treating depression is notable, it is also essential to note that this medication can result in side effects, such as dry mouth, insomnia, and seizures, particularly in patients with a history of seizures. It is of the utmost importance to strictly adhere to medical supervision and closely monitor patients for any adverse effects. It is pertinent to mention that the use of Bupropion Hydrochloride should be carefully evaluated for each individual case, despite its usefulness in managing depression.

Drug Type

Small molecule drug

Synonyms

Amfebutamone Hydrochloride, Bupropion, Bupropion Hrdrochloride

+ [22]

Target

CYP2D6 x DAT x NET x adrenergic receptor

Action

inhibitors, antagonists

Mechanism

CYP2D6 inhibitors(Cytochrome P450 2D6 inhibitors), Dopamine reuptake inhibitors, NET inhibitors(Norepinephrine transporter inhibitors)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Seasonal Affective DisorderDepressive Disorder, MajorNicotine Dependence+ [2]

Inactive Indication

Advanced Malignant Solid NeoplasmAttention Deficit DisorderCrohn Disease+ [5]

Originator Organization

GSK Plc

Active Organization

Research Triangle Institute

Libbs Farmacêutica Ltda.GlaxoSmithKline BV

+ [4]

Inactive Organization

Glaxo Wellcome GmbH & Co. KG

Biovail Corp.

Coordination Pharmaceuticals, Inc.

+ [1]

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (30 Dec 1985),

Depressive Disorder, Major

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC13H19Cl2NO

InChIKeyHEYVINCGKDONRU-UHFFFAOYSA-N

CAS Registry31677-93-7

369

Clinical Trials associated with Bupropion Hydrochloride

NCT07398404

/ Not yet recruitingPhase 1/2IIT

A Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

The purpose of this research study is to evaluate a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery. The intervention will be compared to a standard of care control group.

Start Date01 Jul 2026

Sponsor / Collaborator

Yale University

[+1]

NCT06609343

/ Not yet recruitingPhase 1/2IIT

Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis (BRISK)

Fatigue is the most common symptom reported by end-stage kidney disease patients on maintenance hemodialysis. Unfortunately, there currently is no medical management for this overwhelming feeling of tiredness. As a result, patients continue to suffer with poor quality of life and impaired daily activities. The purpose of this pilot trial is to find out if bupropion (a medicine commonly prescribed for stopping smoking, seasonal mood disorder, and depression) may help lessen fatigue in hemodialysis patients.
In this study, hemodialysis participants will receive bupropion tablet orally three times a week during routine dialysis procedure for consecutive 8 weeks. Study participants will complete a battery of questionnaires to self-report fatigue, cognition, and quality of life. The study team will collect biological specimens. All these procedures will be performed at the dialysis clinic during routine dialysis procedure.

Start Date01 Jun 2026

Sponsor / Collaborator

University of Texas Health Science Center At San Antonio

NCT07224087

/ RecruitingPhase 1IIT

Development of a Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

The purpose of this research study is to develop and pilot a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery.

Start Date02 Mar 2026

Sponsor / Collaborator

Yale University

[+1]

100 Clinical Results associated with Bupropion Hydrochloride

100 Translational Medicine associated with Bupropion Hydrochloride

100 Patents (Medical) associated with Bupropion Hydrochloride

913

Literatures (Medical) associated with Bupropion Hydrochloride

01 Mar 2026·JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Pharmacogenetic influence on bupropion bioactivation and clinical outcomes in major depressive disorder

Article

Author: Kharasch, Evan D ; Lenze, Eric J

This investigation addressed influences of CYP2B6 and CYP2C19 genetic polymorphisms on steady-state bupropion disposition, antidepressant outcomes and side effects, and evaluated influences of pharmacokinetic variability on pharmacogenetic results. This was a preplanned secondary analysis of a prospective, 24-week, randomized, double-blind, crossover trial which compared pharmacokinetics and antidepressant effects across brand and 3 generic bupropion XL 300 mg drug products in 70 participants with major depressive disorder in remission, who were genotyped for CYP2B6 and CYP2C19 polymorphisms. We measured steady-state enantiomeric plasma and urine bupropion and primary (hydroxybupropion, a bioactivation pathway), reduced, and secondary metabolites, clinical depression (Montgomery-Asberg depression rating scale), side effects, and influence of CYP2B6 and CYP2C19 polymorphisms on bupropion disposition and drug effects across all 4 drug products (pooled analysis). Results showed that CYP2B6 polymorphisms (CYP2B6∗6 allele and the 516G>T variant alone) had a significant influence on bupropion disposition, including apparent oral clearance and enantiomers hydroxylation. Since bioactivation via bupropion hydroxylation has therapeutic importance, CYP2B6 polymorphisms could be clinically relevant. However, there were no significant differences between CYP2B6∗6 or 516G>T gene groups in either depression or side effect scores, at baseline on patients' own bupropion, or during the crossover phase of 4 bupropion products. CYP2C19 polymorphisms had a small and clinically unimportant influence on bupropion minor metabolites and secondary metabolism, and no effect on depression or side effect scores. Results show that CYP2B6 polymorphisms significantly influenced bupropion enantiomers steady-state disposition, but not long-term antidepressant or side effects. These findings may have relevance for clinical pharmacogenetic testing in depression. SIGNIFICANCE STATEMENT: This pharmacogenetic study in major depressive disorder evaluated both pharmacokinetics and clinical effects. CYP2B6 polymorphisms (CYP2B6∗6 allele, 516G>T variant) had significant influence on steady-state bupropion enantiomers apparent oral clearance and hydroxylation, but there was no association between CYP2B6∗6 or 516G>T gene groups and either depression or drug side effects. CYP2C19 polymorphisms had a small and clinically unimportant influence on bupropion minor metabolites and secondary metabolism and no effect on depression or side effect scores. These results may have implications for genetic testing in bupropion pharmacotherapy of major depressive disorder.

20 Feb 2026·Cureus Journal of Medical Science

New-Onset Tic Disorder Associated With Bupropion XL: A Rare Case

Article

Author: Rashid, Ovais ; Kaur, Simranjeet ; Hooda, Priyanka

[This corrects the article DOI: 10.7759/cureus.102855.].

02 Jan 2026·Expert Opinion on Drug Metabolism & Toxicology

Abuse liability of dextromethorphan and its combinatory formulation dextromethorphan/bupropion: a pharmacologic perspective

Review

Author: Kwan, Angela T H ; Teopiz, Kayla M ; Dri, Christine E ; Zheng, Yang Jing ; McIntyre, Roger S ; Wong, Sabrina ; Le, Gia Han

INTRODUCTION:

Dextromethorphan/Buproprion (DXM/BUP) has received breakthrough FDA approval in August 2022 as a rapid-acting antidepressant. DXM/BUP is a noncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist and sigma-1 receptor agonist, with bupropion (BUP), a norepinephrine/dopamine reuptake inhibitor and cytochrome P450 2D6 (CYP2D6) inhibitor. As DXM/BUP moves closer to widespread clinical use for MDD, examining whether the combination does or does not carry meaningful abuse liability is essential given that DXM alone has long been misused, likely attributed to its metabolism into the psychoactive metabolite DXO.

AREAS COVERED:

We discuss the pharmacodynamics and pharmacokinetics of DXM and its primary active metabolite, dextrorphan (DXO). We then highlight the abuse potential of DXM when administered alone. Additionally, we present preclinical, clinical, and pharmacovigilance findings that support the reduced abuse liability of DXM/BUP.

EXPERT OPINION:

The formulation demonstrates clinically meaningful improvement within one week of its initiation. Given its safety and efficacy, alongside its novelty, this glutamatergic modulator represents a promising candidate for approval across global jurisdictions and regions. Future research should examine DXM/BUP's potential efficacy in bipolar depression and trauma-associated MDD, populations exhibiting refractory responses to conventional antidepressants and in need of an alternative, mechanistically distinct therapeutic.

149

News (Medical) associated with Bupropion Hydrochloride

01 Apr 2026

·www.prnewswire.com

Currax Expands Patient Access to FDA-Approved Obesity Treatment with PeekDirect™

Contrave, the #1 branded oral non-GLP-1 weight loss medication* is now available to self-funded employers through Peek BRENTWOOD, Tenn., April 1, 2026 /PRNewswire/ -- Currax Pharmaceuticals LLC ("Currax"), a specialty pharmaceutical company and manufacturer of the #1 branded oral non-GLP-1 weight loss medication CONTRAVE® (naltrexone HCl/bupropion HCl)*, today announced expanded access to CONTRAVE® through PeekDirect, in partnership with Peek Healthcare Technologies, Inc. ("Peek"). PeekDirect is Peek's access model that connects employers and patients directly with pharmaceutical manufacturers to deliver transparent, upfront pricing at the point of prescription. In partnership with Professional Arts Specialty Pharmacy, dispensing pharmacy partner for both PeekDirect and Currax, the program provides manufacturers with a seamless patient experience and a turnkey distribution channel. Traditional, rebate-driven access models distort pricing and are overly complicated. PeekDirect cuts through the complexity, eliminates the middlemen and delivers predictable pricing and lower out-of-pocket costs. With no change to how physicians prescribe or how patients access their medications – PeekDirect is a simpler path to affordability. "Expanding patient access is central to who we are and how we operate at Currax," said George Hampton, President and CEO of Currax. "Our partnership with PeekDirect removes unnecessary intermediaries and gives patients straightforward access to our FDA-approved obesity treatment. Our priority is to ensure cost savings reach patients." "Peek is about bringing transparency and affordability into the healthcare system," said Michael Navin, CEO of Peek. "Our partnership with Currax is another important step forward, expanding access to therapies through a more transparent and efficient distribution model. Employers can now offer meaningful savings, while patients gain direct access to the medications they need without unnecessary barriers." *Based on the number of prescriptions filled for brand name weight-loss drugs in the IQVIA database in November 2025. About Peek Peek is a healthcare technology company that connects biopharma, employers, and patients with affordable, direct access to specialty and high-cost medicines. By eliminating unnecessary intermediaries, Peek helps organizations deliver better benefits while lowering costs and improving access. For more information, visit peekmeds.com. About Currax Currax is a specialty pharmaceutical company that pursues transformative therapies for chronic conditions like obesity. Combining innovative advancements with compassionate care, Currax delivers therapies that are designed to inspire hope and offer life-changing outcomes. Currax's flagship product, CONTRAVE® (naltrexone HCl/bupropion HCl), reflects the company's commitment to provide therapies that offer unmatched versatility and utility. Learn more at About CONTRAVE: CONTRAVE®, is an extended-release fixed dose combination of naltrexone and bupropion (naltrexone HCl/bupropion HCl) indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or who are overweight in the presence of at least one weight-related comorbid condition. For full Prescribing Information, including BOXED WARNING and Medication Guide, please visit . What is CONTRAVE? CONTRAVE is a prescription weight-loss medicine that may help adults with obesity, or some adults who are overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. CONTRAVE should be used with a reduced-calorie diet and increased physical activity. It is not known if CONTRAVE changes your risk of heart problems or stroke or of death due to heart problems or stroke. CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation). Please see Full Prescribing Information , including Medication Guide , for CONTRAVE. IMPORTANT SAFETY INFORMATION CONTRAVE can cause serious side effects including: Suicidal thoughts or actions: One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment. While taking CONTRAVE, you or your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking CONTRAVE or when your dose changes. Stop taking CONTRAVE and call a healthcare provider right away if you or your family members notice any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood; trouble sleeping. CONTRAVE is not approved for use in children under the age of 18. Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN and ZYBAN; have or have had an eating disorder called anorexia or bulimia; are dependent on opioid pain medicines or use medicines to help stop taking opioids, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti‐seizure medicines and stop using them all of a sudden; are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs) in the past 14 days; or are allergic to any of the ingredients in CONTRAVE. Tell your healthcare provider about all of your medical conditions, including if you have: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant or planning to become pregnant; or breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CONTRAVE may cause serious side effects, including: Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk of seizure is higher in people who take higher doses of CONTRAVE, have certain medical conditions, or take CONTRAVE with certain other medicines. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay to take them. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away. Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death. Get emergency medical help right away if you take opioids and you: have trouble breathing become very drowsy with slowed breathing have slow, shallow breathing feel faint, very dizzy, confused, or have unusual symptoms Sudden opioid withdrawal. People who take CONTRAVE must not use any type of opioid, including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, for at least 7 to 10 days before starting CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery. Severe allergic reactions. Stop taking CONTRAVE and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing. Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking CONTRAVE. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take CONTRAVE. Liver damage or hepatitis. Stop taking CONTRAVE and tell your healthcare provider if you have any of the following symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness. Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem. Manic episodes. Bupropion can cause some people who were manic or depressed in the past to become manic or depressed again. Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your healthcare provider to find out if you are at risk for angle‐closure glaucoma and to get treatment to prevent it if you are at risk. Increased risk of low blood sugar in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas). You should check your blood sugar before you start taking CONTRAVE and while you take CONTRAVE. The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea. These are not all of the possible side effects of CONTRAVE. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088 . Media Contact [email protected] SOURCE Currax Pharmaceuticals LLC 21% more press release views with Request a Demo

Drug Approval

30 Mar 2026

·www.biospace.com

6 FDA Decisions To Watch in Q2 2026

iStock/ Grandbrothers The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss. The second quarter is looking particularly front-loaded for the FDA, which in April is expected to make a handful of highly consequential decisions. One is for a rare disease with high unmet need, while another, for a melanoma treatment, could be a bellwether for how things might change at the agency after the impending departure of a controversial leader. Another key verdict in April is for Eli Lilly’s orforglipron, a weight loss pill that many expect will give Novo Nordisk’s oral Wegovy a run for its money. Here, BioSpace looks at some of the biggest upcoming regulatory decisions expected in the next three months. Biogen Hopes To Bounce Back from High-Dose Spinraza Rejection Following a surprise rejection in September last year, Biogen is once again awaiting the FDA’s word on its high-dose formulation of the antisense oligonucleotide Spinraza, being proposed for the treatment of spinal muscular atrophy (SMA). The agency is expected to release a decision on or before April 3. Biogen is supporting its application with data from the Phase 2/3 DEVOTE study, which in September 2024 demonstrated that higher-dose Spinraza—comprising two 50 mg loading doses 14 days apart and a maintenance regimen of 28 mg every 4 months—led to better improvements in motor skills versus sham control. The higher-dose formulation of the drug likewise outperformed the standard-dose version in this regard, though the company at the time did not release its statistical analysis for this comparison. At the recently concluded 2026 meeting of the Muscular Dystrophy Association, Biogen posted updated data from DEVOTE—as well as from an open-label Phase 3 study called ONWARD—confirming that the higher-dose formulation of Spinraza is significantly better than sham at improving motor skills. Higher-dose Spinraza likewise outperformed sham in terms of secondary endpoints such as neurofilament light chain levels and event-free survival. The FDA’s rejection of Spinraza in September 2025 was not due to the drug’s data package but was instead linked to manufacturing issues . Moment of Truth for Lilly’s Closely Watched Weight Loss Pill In what could be its most consequential verdict for the weight loss space this year, the FDA will render a decision on Eli Lilly’s oral obesity medicine orforglipron on or before April 10. Analysts expect orforglipron to help Lilly’s trizepatide franchise—consisting of the diabetes drug Mounjaro and the weight management brand Zepbound—to exceed $100 billion in peak revenue. If approved, orforglipron will challenge Novo Nordisk’s oral Wegovy, which has a three-month headstart after winning approval late last year . Despite Novo’s first-to-market advantage, Lilly might have an efficacy edge. Data from the Phase 3 ACHIEVE-3 study released last month showed that orforglipron elicited greater weight loss and better glycemic control than oral semaglutide—marketed as Rybelsus for diabetes—in patients with type 2 diabetes whose condition is inadequately controlled by metformin. The FDA awarded orforglipron its Commissioner’s National Priority Voucher in November 2025, promising a 1-2-month review period. However, the agency delayed its decision in January by two weeks, according to Reuters . If approved, Lilly will be ready to launch orforglipron quickly. The pharma has already stockpiled some $1.5 billion worth of the drug, ready for deployment, and has been ramping up production capacity since February 2024. FDA FDA Delays Decision for Lilly’s Obesity Pill Orforglipron, Other Priority Voucher Awardees: Report Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program. January 15, 2026 · 2 min read · Tristan Manalac Read more Replimune Gives Tumor Destroyer Another Try Like Biogen, Replimune is looking to bounce back from a rejection. The FDA is expected to release a decision for the company’s oncolytic immunotherapy RP1 for advanced melanoma by April 10. The regulator rejected RP1 in July last year, claiming that Replimune’s pivotal IGNYTE study was not adequate and well-controlled and therefore could not support an approval. This feedback, Replimine CEO Sushil Patel said at the time, was “not raised by the agency during the mid- and late-cycle reviews.” Analysts at BMO Capital Markets had a more pointed analysis of the rejection, indicating that Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, played a role. “Prasad has previously been critical of the approvability of uncontrolled data, and today we see that opinion underscored,” the firm wrote in a July 22, 2025 note to investors. In October last year, Replimune resubmitted its data package for RP1, beefing it up with additional data and analyses. Also potentially playing in Replimune’s favor is the impending departure of Prasad, who will leave the FDA at the end of April. RP1 makes use of a proprietary and engineered herpes simplex virus that carries a fusion protein. Taken together, this construct seeks out and destroys cancer cells, while also altering the microenvironment and stimulating the body’s antitumor immune response. RP1 is meant to be used in combination with Bristol Myers Squibb’s Opdivo. Immuno-oncology Replimune Plummets Following FDA’s Surprise Rejection of Melanoma Treatment BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the agency’s decision to issue a complete response letter for Replimune’s viral treatment RP1 for advanced melanomas. Shares of the company tumbled 75% on Tuesday. July 22, 2025 · 1 min read · Dan Samorodnitsky Read more Axsome Awaits FDA Action on Alzheimer’s Agitation Drug By April 30, the FDA will release its verdict on Axsome Therapeutics’ oral drug AXS-05 for the treatment of agitation in patients with Alzheimer’s disease. Around 7 million people in the U.S. have Alzheimer’s, according to Axsome, 76% of whom experience agitation characterized by distress, aggressiveness and irritability. AXS-05 combines two drugs—dextromethorphan and bupropion—and works by blocking the NMDA receptor and activating the sigma-1 receptor, while also inhibiting the aminoketone CYP2D6 enzyme. In January 2025, Axsome posted mixed late-stage data for the drug. In the Phase 3 ACCORD-2 study, AXS-05 reduced the risk of relapse of agitation by 3.6-fold compared with placebo. A smaller Phase 3 study dubbed ACCORD-1 likewise met its primary endpoint of delaying time to relapse in 2022. However, in the Phase 3 ADVANCE-2 trial, which randomized more than 400 patients, Axsome’s drug failed to significantly outperform placebo in terms of easing agitation. The biotech nevertheless said at the time that it would move forward with an application. AXS-05 is already approved in the U.S. under the brand name Auvelity for the treatment of major depressive disorder. After Maintenance Win, Biogen, Eisai Target SubQ Expansion for Leqembi Initiation In September last year, the FDA cleared a subcutaneous formulation of Biogen and Eisai’s anti-amyloid Alzheimer’s disease therapy Leqembi, allowing it to be delivered via an under-the-skin injection rather than IV—but only in patients who have already completed 18 months of treatment with the drug. Now, the partners are looking to expand the subcutaneous injection, branded as Leqembi Iqlik, to the induction setting. The FDA is currently reviewing the proposal and is expected to release a decision by May 24. In their data package, Biogen and Eisai provided data showing that a weekly subcutaneous injection provides bioequivalent drug exposure to an intravenous infusion given once every two weeks. If approved, Leqembi Iqlik would become the first anti-amyloid therapy that patients can inject at home both for induction and maintenance treatment, according to a January 2026 press announcement from the companies. An approval is “going to be also extremely important,” Biogen CEO Christopher Viehbacher told investors at the company’s J.P. Morgan presentation in January. The chief executive noted that Biogen has a competitor in the anti-amyloid antibody space, “and the competitor offers once-monthly infusion versus our every 2-week infusion.” This competitor would be Eli Lilly’s Kisunla. “That advantage is going to go away once we have a subcutaneous formulation,” Viehbacher said. Neurodegenerative disease JPM26: With Leqembi Launched, Biogen Looks To Expand Alzheimer’s Presence Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates. January 14, 2026 · 5 min read · Heather McKenzie Read more Review Comes to Close for AstraZeneca’s Lipid-Lowering Pill AstraZeneca is looking to open up a new drug class. The company is awaiting the FDA’s word on its aldosterone synthase inhibitor baxdrostat for patients with uncontrolled or treatment-resistant hypertension, which, if approved, would be the first aldosterone synthase blocker to pass the FDA’s muster, AstraZeneca said in December last year . The pharma hasn’t specified a target action date for the application, only revealing that a decision should come in the second quarter. The pharma is backing baxdrostat with data from the Phase 3 BaxHTN study, in which a 2-mg dose of the drug demonstrated an up to 9.8-mmHg placebo-corrected reduction in systolic blood pressure, according to an August 2025 publication in The New England Journal of Medicine . BaxHTN used baxdrostat on top of standard of care and also aced all of its secondary endpoints. The drug, taken orally, works by inhibiting the aldosterone synthase enzyme, which otherwise produces a steroid that promotes sodium retention, in turn maintaining blood pressure levels. AstraZeneca obtained baxdrostat from its $1.3 billion takeover of CinCor Pharma in 2023.

Phase 3Clinical ResultAcquisitionDrug Approval

29 Mar 2026

·www.sciencedaily.com

Scientists say the evidence is clear: E-cigarettes beat patches and gum in helping smokers quit

Nicotine e-cigarettes may be one of the most effective tools yet for quitting smoking, according to a sweeping review of global research. By analyzing findings from 14 major reviews spanning nearly a decade, researchers found consistent, high-quality evidence showing that nicotine vapes outperform traditional methods like patches, gum, and even behavioral support. While some lower-quality studies produced mixed results, the strongest data clearly favored nicotine e-cigarettes.A comprehensive review of global research on smoking cessation suggests that e-cigarettes containing nicotine may help more people quit smoking than other commonly used methods. These include nicotine replacement therapy (nicotine patches, gum, lozenges, etc.) as well as non-nicotine e-cigarettes and behavioral support programs. The analysis brings together findings from multiple systematic reviews to provide a clearer picture of what works best for quitting smoking. In total, researchers combined results from fourteen systematic reviews conducted between 2014 and 2023, making the evidence easier to interpret and compare. Strongest Evidence Favors Nicotine E-Cigarettes When focusing on the highest-quality studies, the results consistently show that nicotine e-cigarettes lead to higher quit rates than other approaches. In contrast, lower-quality studies produced less consistent and more uncertain findings. Overall, the most reliable evidence points to nicotine e-cigarettes outperforming nicotine replacement therapy, non-nicotine e-cigarettes, and other alternatives. As part of the project, researchers developed an 'Evidence and Gap Map' (EGM) to highlight areas where more research is needed. Currently, there are no high-quality systematic reviews directly comparing nicotine e-cigarettes with treatments such as cytisine, bupropion, or nicotine pouches. Evidence comparing e-cigarettes with varenicline is also very limited, based on just one small study with a high risk of bias. The EGM also indicates that evidence on serious adverse events linked to e-cigarettes remains uncertain. In addition, most of the available data comes from high-income countries. Researchers emphasize the need for future studies to better track potential risks and to include populations from low-and middle-income countries. Researchers Say Evidence Is Clear Lead author Dr. Angela Difeng Wu, Senior Researcher and Lecturer at the Nuffield Department of Primary Care Health Sciences, University of Oxford, says "We hope this overview and Evidence and Gap Map can lay to rest some claims that evidence is 'mixed' regarding the impacts of nicotine e-cigarettes on smoking abstinence. In fact, the evidence is clear and consistent across all of the meta-analyses we consulted: e-cigarettes are effective at helping people stop smoking." This research work was funded by Cancer Research UK, Grant Number PRCPJT‐Nov22/100012.

Clinical Result

100 Deals associated with Bupropion Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00817	Bupropion Hydrochloride	N06AX12	DB01156

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Seasonal Affective Disorder	United States	Bausch Health US LLC	12 Jun 2006
Nicotine Dependence	Belgium	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Denmark	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Finland	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	France	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Germany	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Iceland	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Ireland	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Italy	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Luxembourg	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Netherlands	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Norway	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Portugal	GlaxoSmithKline BV	25 Apr 2000
Nicotine Dependence	Sweden	GlaxoSmithKline BV	25 Apr 2000
Depressive Disorder	United States	GSK Plc	04 Oct 1996
Depressive Disorder, Major	United States	GSK Plc	30 Dec 1985

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Smoking Cessation	Phase 3	United States	GSK Plc	01 Jun 2009
Crohn Disease	Phase 3	United States	GSK Plc	01 May 2005
Sexual Dysfunction	Phase 3	United States	GSK Plc	01 May 2004
Sexual Dysfunctions, Psychological	Phase 3	United States	GSK Plc	01 May 2004
Attention Deficit Disorder	Phase 3	United States	GSK Plc	01 Oct 2002
Advanced Malignant Solid Neoplasm	Phase 1	United States	Coordination Pharmaceuticals, Inc.	15 Jun 2021
Diabetes Mellitus, Type 2	Phase 1	United States	GSK Plc	16 Jan 2008
Drug abuse	Phase 1	United States	GSK Plc	01 Sep 2002
HIV Infections	Phase 1	United States	GSK Plc	01 Sep 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04490057 (Pubmed \| JAMA Netw Open)	Phase 4	Tobacco Use Disorder	323	NRT plus CM	yrbvpeogzo(hxnimhootz) = mzscnozdnl igdathzfci (hieejslair ) View more	Positive	27 Feb 2026
				NRT	yrbvpeogzo(hxnimhootz) = iijqblbvqx igdathzfci (hieejslair ) View more
NCT00958633 (CTgov)	Phase 3	Bipolar I disorder	237	Escitalopram+Bupropion XL (8 Week Arm)	cnrdfehrue = skbngamhfn wbonyysxtg (dssyoelhqm, pdejxdfhmi - qferghteaa) View more	-	15 May 2025
				Escitalopram+Bupropion XL (52 Week Arm)	cnrdfehrue = eytvlychki wbonyysxtg (dssyoelhqm, znuxkldxkb - pgfedzdvpp) View more
NCT03342027 (CTgov)	Phase 3	Smoking Cessation \| HIV Infections	300	Positively smoke free+Bupropion (Bupropion + Positively Smoke Free)	puhmhpzqqx = iymnyiekbb rwjcxupdog (ycpxpyfmuk, pcjfoqygfd - whwxbaffkq) View more	-	05 Feb 2025
				Bupropion+Brief advice to quit smoking (Bupropion + Standard of Care)	puhmhpzqqx = gwvygacpjp rwjcxupdog (ycpxpyfmuk, xccbapljpw - eeifdqwita) View more
NCT04167306 (CTgov)	Phase 2	Alcoholism	388	Placebo for bupropion+Varenicline Tartrate 1 mg b.i.d (2) Varenicline + Placebo for Bupropion)	wixtkzoyqd(anueqgcdkx) = qspcvntsvf hufiweygch (mpemshhexb, 0.057) View more	-	07 Jun 2024
				Bupropion Hydrochloride+Varenicline Tartrate 1 mg b.i.d (1) Varenicline + Bupropion)	wixtkzoyqd(anueqgcdkx) = frssabufih hufiweygch (mpemshhexb, 0.041) View more
ISC2024	Not Applicable	Acute Ischemic Stroke	-	SSRI/SNRI	sibfdiartz(jxmwqdrche): RR = 1.29 (95% CI, 1.11 - 1.5)	-	01 Feb 2024
				Dual Antiplatelet Therapy (DAPT)
NCT03362099 (GENTSMOKING, Pubmed \| Tob Induc Dis) Manual	Phase 4	Smoking Cessation CYP2B6 rs2279343 \| CHRNA4 rs1044396	361	Bupropionvarenicline	czwgvsusyz(ndvhyqrqtc) = hqizvlcbgp vdekszkbla (zpvnhyywyw, 49 - 64) View more	Negative	01 Jan 2024
				Varenicline	czwgvsusyz(ndvhyqrqtc) = ergbngfkvv vdekszkbla (zpvnhyywyw, 67 - 80) View more
NCT04352101 (CTgov)	Phase 4	Anhedonia \| Depressive Disorder, Major \| Inflammation	18	Bupropion XL (Bupropion)	ihutyboimu(jqhqoolwfo) = hkvfrjmbev lcttwrmctz (xfgnksaege, 0.14) View more	-	29 Dec 2023
				Escitalopram (Escitalopram)	ihutyboimu(jqhqoolwfo) = orwsrosyvo lcttwrmctz (xfgnksaege, 0.16) View more
NCT03993457 (PRECISE-D, CTgov)	Phase 4	-	18	Escitalopram (CRP<1, CRP Consistent Antidepressant Selection)	uelibbkiwe = iygqumzrdq mgznxghkqa (jvxlgxgsck, hiluuchfvo - mtpoqpivcp) View more	-	18 Apr 2023
				Bupropion (CRP> or Equal to 1, CRP Consistent Antidepressant Selection)	uelibbkiwe = gzjvojofio mgznxghkqa (jvxlgxgsck, lgftbgvmyw - rlowtsixjd) View more
NCT03897439 (CTgov)	Phase 3	Smoking Cessation	392	Nicotine patch (Usual Care (UC))	yejcioyyel = dmqeaqvggf fpqqwlammw (seeugtjvpg, dzxucdeoqq - hfdvvpvnpt) View more	-	03 Apr 2023
				Bupropion+Nicotine patch+Varenicline Tartrate (Optimized Care (OPT))	yejcioyyel = cnlxsqeqfc fpqqwlammw (seeugtjvpg, epoyhbhkxb - idcjqlejpw) View more
NAASO2022	Not Applicable	Binge-Eating Disorder	136	Naltrexone+Bupropion	kivzedkfwu(czrulmujoy) = jsvumskhvy akxukypbpu (ywrvecvkqs )	Positive	21 Nov 2022
				Behavioral weight-loss therapy	kivzedkfwu(czrulmujoy) = ovltxrhhti akxukypbpu (ywrvecvkqs )

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis