A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate the efficiency and effectiveness of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT adaptive clinical trial.

Start Date10 Aug 2026

Sponsor / Collaborator

Fundación para la Investigación Biomédica del Hospital

CTRI/2026/06/113145

/ Not yet recruitingNot Applicable

A prospective singlecenter randomized openlabel explorative study to evaluate the safety and effectiveness of Fluvoxamine and Fluoxetine in managing obsessive compulsive disorder OCD in a real world setting - NIL

Start Date17 Jul 2026

Sponsor / Collaborator

Abbott Healthcare Pvt Ltd.

NCT07359482

/ RecruitingPhase 3IIT

sElective Serotonin reuPtake inhibitoRs In posT-covid: ESPRIT

Fatigue, cognitive problems, post-exertional malaise (PEM) and postural orthostatic tachycardia syndrome (POTS) are common and debilitating symptoms after COVID-19. The pathophysiology of post-COVID is not well understood and there is no established biomedical treatment. Treatment options for post-COVID are thus much needed.
A promising candidate intervention is fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), that may reduce post-COVID symptoms because of its regulatory effect on the (neuro) immune system, the hypothalamic-pituitary-adrenal (HPA) axis and the tryptophan system. The investigators will randomize 160 participants to either fluvoxamine or placebo for 12 weeks.
The investigators will use advanced functional neuroimaging techniques during cognitive challenge (optional substudy) and plasma biomarkers (inflammatory markers, cortisol, serotonin, IDO-2 activity), to facilitate identifying potential mechanistic pathways of post -COVID treatment.

Start Date04 Jun 2026

Sponsor / Collaborator

Academic Medical Center University of Amsterdam

100 Clinical Results associated with Fluvoxamine Maleate

100 Translational Medicine associated with Fluvoxamine Maleate

100 Patents (Medical) associated with Fluvoxamine Maleate

3,762

Literatures (Medical) associated with Fluvoxamine Maleate

01 Aug 2026·British Journal of Pharmacology

Requirement of sigma‐1 receptor (Sig‐1R) for boosting the gamma oscillations in the medial prefrontal cortex (mPFC)

Article

Author: Zhao, Jia‐Ning ; Sun, Si‐Rui ; Bi, Peng‐Wei ; Yin, Yong‐Yu ; Lv, Ze ; Li, Yun‐Feng ; Zhang, Hui‐Ying ; Zhang, Li‐Ming

Abstract:

Background and Purpose:

Gamma oscillations have emerged as a promising biomarker of depression, but the underlying molecular mechanism remains unknown. Sigma‐1 receptors (Sig‐1R) have attracted increasing interest, and this study aims to investigate their role in regulating gamma oscillations.

Experimental Approach:

Electrophysiological recordings and calcium signal recordings in freely walking mice were used to record the dynamic changes of neural activities in response to drug treatments. SSRIs with varying affinities for Sig‐1R and AAV virus for overexpression were used to pharmacologically and genetically manipulate Sig‐1Rs.

Key Results:

SA4503 (a selective Sig‐1R agonist, 3 mg·kg −1 , i.p.) significantly increased firing rates and Ca 2+ signals of pyramidal neurons and gamma oscillations in the medial prefrontal cortex (mPFC), but paroxetine (low affinity for Sig‐1R among SSRIs, 10 mg·kg −1 , i.p.) has no such effects under the same conditions. Conversely, fluvoxamine (high affinity for Sig‐1R among SSRIs, 30 mg·kg −1 , i.p.), significantly increased firing rates and Ca 2+ signals of pyramidal neurons and gamma oscillations, and these electrophysiological properties were reversed by BD1047 (a selective Sig‐1R antagonist, 3 mg·kg −1 , i.p.). In addition, our results showed that BD1047 blocked the enhancement in gamma oscillations induced by Ro 10‐5824 (3 mg·kg −1 , i.p.); Sig‐1R overexpression greatly increased firing rates and Ca 2+ signals of pyramidal neurons and gamma oscillations.

Conclusion and Implications:

We propose the important role of Sig‐1R in modulating gamma oscillations, and SSRIs displayed varying abilities to boost gamma oscillations in the mPFC based on their affinity for Sig‐1R, which yields new insights into the molecular mechanism underlying gamma oscillations.

01 Aug 2026·CPT-Pharmacometrics & Systems Pharmacology

A Physiologically Based Pharmacokinetic Model to Predict Potential Drug–Drug Interactions of TPN171 , a Novel Phosphodiesterase Type 5 Inhibitor

Article

Author: Duan, Yuanqin ; Li, Lei ; Jia, Jingying ; Yang, Hao ; Wang, Zhiqiang ; Tian, Guanghui ; Chen, Tao ; Juan, Jiaxiang ; Pei, Jianghong

ABSTRACT:

TPN171 is a potent phosphodiesterase type 5 inhibitor used to treat pulmonary arterial hypertension and erectile dysfunction, primarily metabolized by CYP3A4. This study aimed to evaluate its drug–drug interaction (DDI) potential and determine the optimal dosing when co‐administered with CYP3A4 modulators. A physiologically based pharmacokinetic (PBPK) model was developed and validated using clinical DDI data for itraconazole (strong CYP3A4 inhibitor) and rifampin (strong CYP3A4 inducer). The model was then applied to predict DDIs with moderate (diltiazem, fluconazole) and mild (fluvoxamine) inhibitors, as well as moderate (efavirenz) and mild (zanubrutinib) inducers. Predicted AUC 0−t ratios aligned with observed data: itraconazole (2.42‐fold predicted vs. 2.67‐ fold observed) and rifampicin (0.14‐fold predicted vs. 0.096‐fold observed). For other modulators, geometric mean AUC 0−t ratios were 2.40 with diltiazem, 3.27 with fluconazole (400 mg), 2.07 with fluconazole (100 mg), 1.16 with fluvoxamine, 0.53 with efavirenz, and 0.70 with zanubrutinib. These simulations indicate that strong and moderate CYP3A4 inhibitors and inducers significantly alter TPN171 exposure, whereas weak modulators have no clinically meaningful impact. These findings provide a scientific basis for dose recommendations when TPN171 is used with CYP3A4 modulators.

03 Jul 2026·Expert Opinion On Drug Safety

Cutaneous toxicity induced by antidepressants and second-generation antipsychotics in the United States food and drug administration adverse event reporting system

Article

Author: Chong Chen ; Wensi Huang ; Luyao He ; Yueyue Yuan ; Mengting Shen

BACKGROUND:

Adverse cutaneous drug reactions have been reported with most drugs, including antidepressants (ADs) and second-generation antipsychotics (SGAs). The lack of extensive research on the relationship between ADs and SGAs, and cutaneous toxicity remains troubling. Our study aimed to assess the cutaneous toxicity of ADs and SGAs and provide valuable insights for clinical applications and scientific investigations.

RESEARCH DESIGN AND METHODS:

We conduct a pharmacovigilance study based of the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analysis the relationship of ADs and SGAs and cutaneous adverse events. Reporting odds ratios (ROR) and information components (IC) were presented using statistical shrinkage transformation.

RESULTS:

Comparing ACDRs to other ADRs, each AD (fluoxetine (ROR₀₂₅ = 1.49), fluvoxamine (ROR₀₂₅= 1.14), paroxetine (ROR₀₂₅ = 1.49), escitalopram (ROR₀₂₅ = 1.79), sertraline (ROR₀₂₅ = 1.44), venlafaxine (ROR₀₂₅= 1.46) and duloxetine (ROR₀₂₅ = 1.69)) showed significantly more cases. There was no association between SGA and cutaneous toxicity. The spectrum displayed strong signals in duloxetine-induced genital ulceration (IC₀₂₅ = 2.75) and amisulpride-induced conjunctivitis (IC₀₂₅ = 2.56).

DISCUSSION:

This study provides a valuable foundation for clinical practice and medication monitoring by thoroughly analyzing, methodically evaluating, and quantifying the potential dermal toxicity of ADs and SGAs.

News (Medical) associated with Fluvoxamine Maleate

18 Jul 2026

·www.sciencedaily.com

Common antidepressant may ease long COVID’s crushing fatigue

A low-cost antidepressant may offer new hope for people struggling with long COVID fatigue. In a randomized clinical trial involving 399 adults, fluvoxamine significantly reduced fatigue and improved quality of life compared with a placebo, making it one of the first medications to show meaningful benefits for this disabling condition.A widely available antidepressant may provide meaningful relief for people experiencing persistent fatigue from long COVID, according to a global clinical trial co-led by McMaster University. Researchers found that fluvoxamine (sold under the brand name Luvox), an inexpensive medication already commonly used to treat depression and other conditions, reduced fatigue and improved quality of life in adults with long COVID. The randomized, placebo-controlled trial was published in the Annals of Internal Medicine. A Potential Treatment for Long COVID Fatigue Fatigue is among the most frequent and disabling symptoms reported by people with long COVID. For some, the exhaustion is severe enough to interfere with employment, family responsibilities, and everyday activities. Despite the scale of the problem, there are still few treatments supported by strong clinical evidence. "This is an important step forward for patients who have been desperate for evidence-based options," says Edward Mills, senior author, professor in McMaster's Department of Health Research Methods, Evidence, and Impact, and co-principal investigator of the trial. "Fluvoxamine showed consistent and meaningful benefits, and because it's already widely used and well understood, it has clear potential for clinical use." Researchers from Canada, Brazil, and the United States jointly led the study. Clinical sites were located in Belo Horizonte and throughout Minas Gerais, Brazil. The REVIVE-TOGETHER trial brought together investigators from McMaster University, the University of British Columbia, Stanford University, the University of Pittsburgh, Duke University, Georgetown University, and several Brazilian institutions. Testing Fluvoxamine and Metformin The trial included 399 adults in Brazil who had experienced ongoing fatigue for at least 90 days after a confirmed SARS-CoV-2 infection. Participants were randomly placed into one of three groups and received fluvoxamine (sold under the brand name Luvox), metformin (a common diabetes medication), or a placebo for 60 days. "We wanted to test whether two existing, widely available, and affordable medications could help. Both had biological reasons to think they might work against long COVID fatigue, but neither had been rigorously tested for this purpose in a proper clinical trial," says Mills. Fluvoxamine performed better than the placebo in reducing fatigue. The statistical analysis indicated a 99 percent probability that the medication was more effective than the placebo. Participants who received fluvoxamine also reported gains in overall quality of life across several measures. Metformin did not produce the same results. Earlier research found that taking metformin during the initial stage of a COVID infection could lower the risk of later developing long COVID. In this trial, however, the drug provided no meaningful improvement for people who already had established long COVID fatigue. An Adaptive Clinical Trial Design Researchers used a Bayesian adaptive trial design, which allowed them to end individual treatment groups early once the evidence became sufficiently clear. This approach can produce reliable conclusions more quickly than a conventional trial while maintaining scientific rigor. "The trial used a sophisticated adaptive design that allowed it to reach conclusions more efficiently than traditional trials, stopping early when the evidence was clear enough - a design innovation as important as the findings themselves," says Gilmar Reis, lead author, researcher with Cardresearch, a Brazilian clinical research center based in Belo Horizonte. Reis is also a part-time associate professor at McMaster. More Research Is Still Needed Long COVID continues to pose a major global health challenge and is estimated to affect about 65 million people worldwide. Because proven therapies remain scarce, most medical recommendations focus on supportive strategies, including activity pacing and management of individual symptoms. The researchers caution that fluvoxamine is not a complete solution for long COVID. The condition can involve many different symptoms and biological processes, and the medication appears specifically promising for fatigue management. Additional studies will be needed to determine which patients are most likely to benefit, understand why the drug works, and explore whether it could be used alongside other developing treatments. "This trial gives clinicians their first strong evidence for a medication that helps reduce long COVID fatigue. Patients want something they can try today - and this finding brings us closer to that reality," says Jamie Forrest, corresponding author and postdoctoral research fellow at the University of British Columbia. The research was funded by The Latona Foundation.

03 Apr 2026

·www.drugs.com

Fluvoxamine Improves Fatigue, QoL in Long COVID

FRIDAY, April 3, 2026 -- For patients with postacute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), fluvoxamine seems effective for reducing fatigue and improving quality of life (QoL), according to a study published online March 31 in the Annals of Internal Medicine . Gilmar Reis, M.D., Ph.D., from McMaster University in Hamilton, Ontario, Canada, and colleagues examined the efficacy of fluvoxamine and metformin for long COVID fatigue in a randomized adaptive trial. A total of 399 adults with fatigue persisting 90 or more days after confirmed SARS-CoV-2 infection were enrolled and randomly assigned to 60 days of fluvoxamine (100 mg twice daily), metformin (750 mg twice daily), or matching placebo. The researchers found that compared with placebo, there was a significant reduction in fatigue with fluvoxamine at day 60 as assessed by the Fatigue Severity Scale score (mean difference, -0.43), with a sustained effect at day 90 (mean difference, -0.58). Improvement was also seen in QoL scores with high posterior probability for fluvoxamine. No significant benefit was seen with metformin. Adverse events occurred less often with fluvoxamine versus metformin or placebo (20.0 versus 28.8 and 29.7 percent, respectively). Across all groups, grade 3 and higher adverse events were rare. "This trial gives clinicians their first strong evidence for a medication that helps reduce long COVID fatigue," corresponding author Jamie Forrest, Ph.D., from the University of British Columbia in Vancouver, Canada, said in a statement. "Patients want something they can try today – and this finding brings us closer to that reality." One author disclosed ties to the biopharmaceutical industry. Abstract/Full Text

Clinical Result

02 Apr 2026

·www.biospace.com

Seaport Therapeutics Announces Positive Proof of Concept Topline Results from Ongoing Phase 1 Trial of GlyphAgo™ in Healthy Volunteers

GlyphAgo achieved therapeutic exposures of agomelatine at doses projected to avoid liver enzyme elevations and reduce or eliminate the need for liver function testing that has previously limited agomelatine’s clinical use GlyphAgo demonstrated a statistically significant 6.8-fold increase in bioavailability compared to unmodified agomelatine in healthy volunteers, exceeding the program’s 2-fold target to mitigate liver exposure GlyphAgo substantially reduced pharmacokinetic (PK) variability by 10-fold compared to unmodified agomelatine GlyphAgo was well-tolerated across all evaluated doses, and no serious or severe adverse events or liver-related adverse effects were reported BOSTON--(BUSINESS WIRE)-- Seaport Therapeutics (“Seaport” or the “Company”), a clinical-stage therapeutics company advancing novel neuropsychiatric medicines with a proven strategy and team, today announced positive topline data from its single-ascending dose (SAD) and crossover portions of its Phase 1 proof-of-concept clinical trial evaluating GlyphAgo™ (SPT-320™ or Glyph Agomelatine), a novel, Glyphed oral prodrug of agomelatine in development for generalized anxiety disorder (GAD). The clinical proof-of-concept topline results demonstrated that GlyphAgo exceeded the program’s target of a 2-fold increase in bioavailability compared to unmodified agomelatine, achieving therapeutic levels of agomelatine at substantially lower doses that reduce liver exposure and are projected to reduce or eliminate the need for liver function testing. In the head-to-head crossover portion of the trial, GlyphAgo demonstrated a 6.8-fold increase in bioavailability of agomelatine compared to unmodified orally administered agomelatine. GlyphAgo also showed significantly lower (10-fold) PK variability compared to unmodified agomelatine. The crossover portion included participants who were taking estrogen-containing oral contraceptives that are known to increase agomelatine exposure due to liver drug-drug interaction. In contrast, GlyphAgo exposure was unaffected by oral contraceptives, further supporting the ability of GlyphAgo to bypass first-pass liver metabolism. GlyphAgo demonstrated a 9.6 to 14.5-fold increase in dose-normalized exposure compared to agomelatine in a separate SAD portion of the trial in which no participants were on oral contraceptives. GlyphAgo was well tolerated and no liver-related adverse events (AEs) were observed. The completed SAD and crossover portions of the trial, which included approximately 130 participants, conclude the PK proof-of-concept objectives of the trial, while the ongoing multiple-ascending dose (MAD) portion of this trial – conducted with only GlyphAgo – is intended to further characterize the safety and PK of repeat-dosing of GlyphAgo. “These topline data, from a well-powered Phase 1 trial, strengthen our conviction in GlyphAgo’s potential and provide further clinical validation for the Glyph platform,” said Daphne Zohar, Co-Founder and Chief Executive Officer at Seaport Therapeutics. “Based on these data, we plan to advance GlyphAgo into two parallel trials, a Phase 2a proof-of-pharmacology trial to evaluate the potential sleep benefit of GlyphAgo in patients with GAD, and a Phase 2b trial in GAD, that is a randomized placebo-controlled trial designed to be registration-enabling. We believe that GlyphAgo has the potential to bring patients with generalized anxiety disorder what could be the first new therapy in decades in the U.S. for this underserved and debilitating disorder.” Agomelatine, a clinically validated MT1/MT2 melatonin receptor agonist and serotonin 2C (5-HT2C) receptor antagonist, is an effective anxiolytic and antidepressant approved for the treatment of GAD in Australia and major depressive disorder (MDD) in Australia and the European Union (EU). Agomelatine’s label in both Australia and the EU requires liver function testing before initiating treatment, during treatment, and upon increasing the dose. Agomelatine is not approved in the U.S. “In GAD, agomelatine has demonstrated robust and statistically significant separation from placebo in four third-party placebo-controlled studies 1-4 and has been observed in meta-analysis to have better efficacy and tolerability than selective serotonin-reuptake inhibitors or benzodiazepines,” said Steven Paul, M.D., Co-Founder and Board Chair at Seaport Therapeutics. “Despite this positive profile, over 90 percent of unmodified agomelatine is lost to first-pass metabolism and its use has been limited by dose-dependent liver enzyme elevations. The enhanced pharmaceutical properties of GlyphAgo and resulting markedly reduced inter-individual variability in systemic exposure to agomelatine support our clinical development of GlyphAgo in GAD.” Using Seaport’s proprietary Glyph™ platform, GlyphAgo is designed to enhance lymphatic absorption and avoid first-pass liver metabolism, thereby enhancing oral bioavailability and reducing side effects. By leveraging an alternative absorption pathway via the intestinal lymphatic system used by dietary fats, GlyphAgo is designed to increase systemic exposure of agomelatine, enabling exposure levels of agomelatine that are effective in GAD but at a lower dose that reduces liver exposure and reduces or eliminates the need for liver function testing. Based on the data that Seaport has generated to date, GlyphAgo has the potential to become a leading treatment for GAD. “Agomelatine combines a differentiated mechanism with a favorable efficacy and tolerability pro GAD, but its potential has been previously limited by first-pass liver metabolism and the need for burdensome liver testing,” said Daniel Bonner, Ph.D., Co-Founder and Senior Vice President, Platform, at Seaport Therapeutics. “These results show that GlyphAgo exceeded the targeted improvement in bioavailability, achieving robust exposure, and a more consistent PK pro a substantially lower dose of agomelatine.” Phase 1 Trial Design The Phase 1 proof-of-concept trial is being conducted in multiple parts to evaluate the safety, tolerability, and PK of GlyphAgo and to compare the PK of GlyphAgo to agomelatine alone. The trial includes single and multiple-ascending dose cohorts, as well as a crossover portion, (including both food-effect and within-participant comparison between GlyphAgo and agomelatine), using both open-label and placebo-controlled designs. In the SAD portion of the Phase 1 trial, healthy volunteers received a single administration of either ascending doses of GlyphAgo or a 25 mg dose of agomelatine, an approved efficacious dose in Australia and the EU, to assess PK parameters, including area under the curve (AUC), a measure of overall exposure, and Cmax, or peak plasma concentrations. In the SAD portion, participants were healthy volunteers with no evidence of liver impairment who were not taking any medications or supplements known to alter the PK of agomelatine, including fluvoxamine or estrogen-containing oral contraceptives. In the crossover portion, participants were randomized to one of two sequences designed to assess the food effect on a single dose level of GlyphAgo and compare it with a 25 mg dose of agomelatine. Both sequences evaluated GlyphAgo under fed and fasted conditions before agomelatine, a structure chosen to avoid confounding GlyphAgo safety results with agomelatine’s known liver toxicity. Topline Results Crossover Portion GlyphAgo demonstrated a 6.8-fold increase in dose-normalized AUC compared to agomelatine (90% confidence interval, 4.7 to 10.0x; geometric means). In this portion of the trial, exposure provided by GlyphAgo and unmodified agomelatine were compared head-to-head within the same participants. Statistically significantly lower PK variability (10-fold lower geometric CV% of AUC 0-24 ) was observed between participants dosed with GlyphAgo compared to agomelatine 25 mg (p< 0.0001). It was observed that there is no food effect on agomelatine exposure with GlyphAgo treatment. No clinically significant changes in liver-related laboratory parameters were observed, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), or bilirubin. GlyphAgo achieved a 1.9-fold increase in dose-normalized maximum plasma concentration (Cmax) compared to agomelatine (90% confidence interval, 1.2 to 3.0x). This portion included participants (23%) taking estrogen-containing oral contraceptives, which are known to increase exposure of agomelatine due to liver drug-drug interaction 5 . No effect of estrogen-containing oral contraceptives on GlyphAgo was observed. SAD Portion GlyphAgo demonstrated a 9.6 to 14.5-fold increase in dose-normalized AUC compared to agomelatine and a 2.3 to 3.7-fold increase in dose-normalized Cmax across the doses studied. Participants in the SAD portion were not taking concomitant estrogen-containing oral contraceptives. Across all evaluated dose levels, GlyphAgo was well tolerated, with no serious or severe AEs observed and no clinically significant changes in liver-related laboratory parameters, including ALT, AST, or bilirubin. All treatment groups (GlyphAgo, agomelatine, and placebo) were well-tolerated, with no serious or severe AEs observed. GlyphAgo AUC 0-24 and Cmax increased dose-dependently over the range of doses studied, supporting PK and dose selection for subsequent studies. Seaport plans to present additional analyses from the Phase 1 trial, including the results from the MAD portion, at future upcoming scientific meetings. About GlyphAgo (SPT-320 or Glyph Agomelatine) GlyphAgo is a novel, Glyphed oral prodrug of agomelatine, a clinically validated anxiolytic and antidepressant that is approved for the treatment of GAD in Australia and MDD in Australia and the EU. Using Seaport’s proprietary Glyph platform, GlyphAgo is designed to avoid first-pass liver metabolism and increase systemic exposure of agomelatine, enabling exposure levels of agomelatine that are effective in GAD but at a lower dose that reduces liver exposure and reduces or eliminates the need for liver function testing. Based on internal analyses, Seaport believes a two-fold increase in the bioavailability of agomelatine with GlyphAgo dosing will reduce or eliminate liver enzyme elevations. Based on the data generated to date, Seaport believes GlyphAgo has the potential to become a leading treatment for GAD. About Seaport Therapeutics Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and is guided by an extensive network of renowned scientists, clinicians, and key opinion leaders. For more information, please visit . _________________________ 1 Stein, D.J., et al. (2008). Efficacy of agomelatine in generalized anxiety disorder: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol, 28(5), 561-566; 2 Stein, D.J., et al. (2012). Agomelatine prevents relapse in generalized anxiety disorder: a 6-month randomized, double-blind, placebo-controlled discontinuation study. J Clin Psychiatry, 73(7), 1002-1008; 3 Stein, D.J., et al. (2014). Agomelatine in generalized anxiety disorder: an active comparator and placebo-controlled study. J Clin Psychiatry, 75(4), 362-368; 4 Stein, D.J., et al. (2017). Efficacy and safety of agomelatine (10 or 25 mg/day) in non-depressed out-patients with generalized anxiety disorder: A 12-week, double-blind, placebo-controlled study. Eur Neuropsychopharmacol, 27(5), 526-537; 5. Slee, A., et al. (2019). Pharmacological treatments for generalised anxiety disorder: a systematic review and network meta-analysis. The Lancet, 393(10173), 768–777. 5 Contacts Seaport Therapeutics Public Relations publicrelations@seaporttx.com Investor Relations ir@seaporttx.com

Clinical ResultPhase 1Phase 2Drug Approval

100 Deals associated with Fluvoxamine Maleate

External Link

KEGG	Wiki	ATC	Drug Bank
D00824	Fluvoxamine Maleate	N06AB08	DB00176

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anxiety Disorders	United States	Jazz Pharmaceuticals, Inc.	28 Feb 2008
Osteochondritis Dissecans	United States	Jazz Pharmaceuticals, Inc.	28 Feb 2008
Panic Disorder	United States	Jazz Pharmaceuticals, Inc.	28 Feb 2008
Performance Anxiety	United States	Jazz Pharmaceuticals, Inc.	28 Feb 2008
Phobic Disorders	United States	Jazz Pharmaceuticals, Inc.	28 Feb 2008
Phobia, Social	Japan	Meiji Seika Pharma Co., Ltd.	11 Oct 2005
Phobia, Social	Japan	AbbVie GK	11 Oct 2005
Depressive Disorder	Switzerland	Solvay SA	01 Jan 1983
Obsessive-Compulsive Disorder	Switzerland	Solvay SA	01 Jan 1983

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 2	Hungary	Alfasigma SpA	27 Nov 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05874037 (CTgov)	Phase 2/3	Post Acute COVID 19 Syndrome	191	Fluvoxamine (Fluvoxamine)	mejooiusqo(gdbywtxrgf) = ybfwoddacu blbqxbqayh (hjitweauhf, 8.1) View more	-	25 Jun 2026
				Fluvoxamine (Placebo)	mejooiusqo(gdbywtxrgf) = vbbczwbpme blbqxbqayh (hjitweauhf, 7.0) View more
NCT04885530 (ACTIV-6, CTgov)	Phase 3	COVID-19	10,956	Ivermectin (Arm A - Ivermectin 400)	lkwycofiul = nrfwcciaoy oodauwpdlr (oxolpbnwwj, aqjzplmxfg - wahpvhjtbt) View more	-	17 Nov 2025
				Fluvoxamine (Arm B - Fluvoxamine)	lkwycofiul = hwyzdwlbbs oodauwpdlr (oxolpbnwwj, jposywkubo - spclcpxllo) View more
NCT05894564 (CTgov)	Phase 3	COVID-19	1,208	Fluvoxamine (Arm E - Fluvoxamine 100)	glznsuscgf(xiftcjhcgu) = swxssnquyt hpbrukcapn (rxcvjnsmoy, wecgwniklr - jkfkytaygj) View more	-	20 Feb 2024
				Placebo (Arm E - Placebo)	glznsuscgf(xiftcjhcgu) = qhsbzpwgox hpbrukcapn (rxcvjnsmoy, rrappxflqi - qyatwimmay) View more
NCT04885530 (ACTIV-6, Pubmed \| JAMA)	Phase 3	COVID-19	1,175	Fluvoxamine 100 mg twice daily	fleqpdbzde(prfgurhpuq) = voccygjnmc hipgasjoxy (fkkdzhupqk )	-	26 Dec 2023
				Placebo	fleqpdbzde(prfgurhpuq) = platevfgin hipgasjoxy (fkkdzhupqk )
NCT04885530 (ACTIV-6, Pubmed)	Phase 3	COVID-19 SARS-CoV-2 infection	1,175	Fluvoxamine 100 mg twice daily	dvctgvhpwk(jasqlfoehl) = There were 7 serious adverse events in 6 participants (2 with fluvoxamine and 4 with placebo) xqnchdagbr (hjowivnjax ) View more	Negative	13 Sep 2023
				Placebo
NCT05890586 (CTgov)	Phase 3	COVID-19	1,331	Placebo	vdoxbkrhyh(pzigjlhbat) = uwwiuyzpco wpejijmbnn (wmtvthrynt, qdfojrmqtu - ukyioqsfyn) View more	-	02 Aug 2023
NCT04668950 (The STOP COVID 2 Study, Pubmed \| Open Forum Infect Dis)	Phase 3	COVID-19	547	Fluvoxamine	wbfitjuoah(qsckrpoeqb) = pejwesfmhs gsyxjwpnoi (bdywdutrdx )	Negative	01 Aug 2023
				Placebo	wbfitjuoah(qsckrpoeqb) = gunwplhguu gsyxjwpnoi (bdywdutrdx )
NCT04885530 (ACTIV-6, Pubmed \| JAMA)	Phase 3	COVID-19	1,331	Fluvoxamine 50 mg	khquqetnko(cxqabbuyki) = nxrurorfle qinandkfej (rvalvxhczn )	Negative	12 Jan 2023
				Placebo	khquqetnko(cxqabbuyki) = rjsvzkzcat qinandkfej (rvalvxhczn )
NCT04668950 (The STOP COVID 2 Study, CTgov)	Phase 3	COVID-19	670	Fluvoxamine (Fluvoxamine)	pxwcxeauty = huvidxtiao mtmwbfensp (rihmszfmwz, iommbgoxav - moxokywndy) View more	-	18 Oct 2022
				Placebo (Placebo)	pxwcxeauty = duhfxcnsnl mtmwbfensp (rihmszfmwz, wbywhnceoe - yytiaixkxr) View more
NCT04342663 (STOP COVID, CTgov)	Phase 2	COVID-19	152	Fluvoxamine (Fluvoxamine)	nhgrdgfztg = uhmapjicmn euopmegkfl (itrxzqbfqg, cizrgpjfxu - tvxltvnggw) View more	-	09 Jul 2021
				Placebo (Placebo)	nhgrdgfztg = ufbnemhoqt euopmegkfl (itrxzqbfqg, xveexpggde - hybkjzxesf) View more

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Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis