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Last update 05 Sep 2025

Duloxetine Hydrochloride

Last update 05 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryCYMBALTA® (duloxetine hydrochloride) is an oral medication belonging to the selective serotonin and norepinephrine reuptake inhibitor (SNRI) class. Manufactured by Eli Lilly & Co., it was first approved for use in the US in 2004. CYMBALTA® is indicated for the treatment of major depressive disorder, generalized anxiety disorder in adults and pediatric patients 7 years and older, diabetic peripheral neuropathic pain in adults, fibromyalgia in adults and pediatric patients 13 years and older, and chronic musculoskeletal pain in adults. Its chemical name is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride, with the empirical formula C18H19NOS•HCl and molecular weight of 333.88. It works by inhibiting serotonin and norepinephrine reuptake.

Drug Type

Small molecule drug

Synonyms

(3S)-N-methyl-3-(1-naphthyloxy)-3-(2-thienyl)propan-1-amine, (S)-duloxetine, Ariclaim

+ [17]

Target

NET x SERT

Action

inhibitors

Mechanism

NET inhibitors(Norepinephrine transporter inhibitors), SERT inhibitors(Serotonin transporter inhibitors)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesEndocrinology and Metabolic Disease+ [3]

Active Indication

Diabetic peripheral neuropathyOsteoarthritisLow Back Pain+ [12]

Inactive Indication

Brain Injuries, TraumaticBreast CancerChronic osteoarthritis+ [11]

Originator Organization

Eli Lilly & Co.

Active Organization

Viatris Ltd. (New Zealand)

Eli Lilly & Co.

Zentiva ks

+ [5]

Inactive Organization

Esteve Pharmaceuticals SA

Boehringer Ingelheim GmbHShionogi, Inc.

+ [1]

License Organization

Eli Lilly & Co.

Shionogi & Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (03 Aug 2004),

Depressive Disorder, Major

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC18H20ClNOS

InChIKeyBFFSMCNJSOPUAY-LMOVPXPDSA-N

CAS Registry136434-34-9

548

Clinical Trials associated with Duloxetine Hydrochloride

NCT06614322

/ Not yet recruitingPhase 2IIT

Sensory Phenotyping to Enhance Neuropathic Pain Drug Development (SPENDD): a Randomized, Double-blinded Cross-over Clinical Trial Aimed At Investigating Whether Bedside Quantitative Sensory Testing Can Predict Response to Analgesics.

The goal of this clinical trial is to determine whether quantitative sensory testing (QST) can be used to classify participants into pain sub-groups and predict who will respond best to certain pain treatments in participants with painful peripheral neuropathy.
The analgesic effect is evaluated by measuring pain intensity and Patient Global Impression of Change (PGIC).
This study is a 3-period cross-over trial. This means researchers will compare 3 different drugs (pregabalin, duloxetine, and placebo) over a period of 19 weeks.
Participants will:
* Undergo a quantitative sensory testing (QST) exam.
* Provide a blood sample.
* Complete questionnaires on the computer.
* Take the study drug as instructed.

Start Date01 Sep 2025

Sponsor / Collaborator

University of Rochester

[+1]

NCT05976347

/ RecruitingPhase 4IIT

Identifying and Treating Depression in the Orthopaedic Trauma Population

The goal of this trial is to pilot a way for orthopaedic surgeons to safely screen for depression and provide treatment for depression with medication. The main questions it aims to answer are:
1. What are the outcomes of patients who screen positive for depressive symptoms and are prescribed either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI).
2. What are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?

Start Date25 Jun 2025

Sponsor / Collaborator

Wake Forest School of Medicine

NCT06968624

/ Not yet recruitingPhase 4IIT

"Efficacy and Safety of Single Low-Dose Intravenous Ketamine for Postherpetic Neuralgia With Depression: A Randomized Controlled Study

This clinical trial examines the antidepressant efficacy and safety of a single low-dose intravenous esketamine combined with oral duloxetine in patients with postherpetic neuralgia and depression (duration more than 1 month). In this prospective, randomized, double-blind, placebo-controlled parallel study, eligible patients were randomized into two groups: one received esketamine plus duloxetine, and the other got placebo plus duloxetine. Both groups underwent standard pain management and neuro modulation therapy. The primary outcome was the Hospital Anxiety and Depression Scale - Depression( HADS-D)score at 2 weeks post - infusion, with various secondary outcomes assessed over multiple time points. Data were collected through in-person interviews and telephone follow-ups.

Start Date15 May 2025

Sponsor / Collaborator

Huazhong University of Science & Technology

100 Clinical Results associated with Duloxetine Hydrochloride

100 Translational Medicine associated with Duloxetine Hydrochloride

100 Patents (Medical) associated with Duloxetine Hydrochloride

4,587

Literatures (Medical) associated with Duloxetine Hydrochloride

31 Dec 2025·Gut Microbes

Antidepressant drugs promote the spread of broad-host-range plasmid in mouse and human gut microbiota

Article

Author: Guo, Yinan ; Lei, Tong ; Zhao, Yong ; Engelstädter, Jan ; Schembri, Mark A ; Zhu, Baoli ; Ding, Pengbo ; Lu, Ji ; Wang, Yue ; Guo, Jianhua

Antibiotic resistance is a global public health challenge. The gut microbiota serves as a reservoir for antibiotic resistance genes (ARGs), facilitating their transfer between bacteria. With the rising incidence of major depressive disorders (MDD), antidepressant prescriptions have surged. Previous pure-culture studies suggest that antidepressants exhibit antibiotic-like side effects, but their impact on gene transfer in microbial communities remains unclear. Here, we report that clinically relevant doses of antidepressants duloxetine and sertraline enhance the transfer of a broad-host range conjugative plasmid across bacterial phyla from mice gut microbiota. Tests in human gut simulators confirmed that duloxetine facilitates plasmid transfer in human gut microbiota. Mechanistic analyses revealed that antidepressants increase reactive oxygen species levels and alter bacterial cell membrane permeability. Using fluorescence-activated cell sorting and 16S rRNA gene sequencing, we discovered that antidepressants alter plasmid transfer patterns at both phylum and genus levels, driving ARG exchange among opportunistic pathogens. Our findings suggest that antidepressant use may promote the spread of antibiotic resistance between commensal and pathogenic bacteria, raising important public health concerns.

01 Dec 2025·JOURNAL OF AFFECTIVE DISORDERS

Effect of augmentation with aripiprazole or augmentation with repetitive transcranial magnetic stimulation versus switching to the antidepressant venlafaxine extended release/duloxetine on cognition: A comparative effectiveness research trial for antidepressant incomplete and non-responders with treatment-resistant depression (ASCERTAIN-TRD)

Article

Author: Bystritsky, Alexander ; Trivedi, Madhukar H ; Chaikali, Stefania ; Shelton, Richard C ; Ortiz, Jesús Manuel Hernández ; Vila-Rodriguez, Fidel ; MacGregor, Leslie C ; Nelson, Erik B ; Papakostas, George I ; Fava, Maurizio ; Brawman-Mintzer, Olga ; DeBattista, Charles ; Iosifescu, Dan V ; Carmody, Thomas ; Jha, Manish K ; Mathew, Sanjay J ; Yeung, Albert S ; Dokucu, Mehmet E ; Guidetti, Clotilde ; Thase, Michael E ; McCall, William Vaughn ; Modirrousta, Mandana ; Currier, Glenn W ; Macaluso, Matthew

Subjective cognitive impairment is a key symptom of major depressive disorder (MDD). Improvement of cognitive function in patients with treatment-resistant depression (TRD) is an important treatment outcome. This study compared the impact of augmenting antidepressants with aripiprazole or repetitive transcranial magnetic stimulation (rTMS) versus switching to venlafaxine (or duloxetine for those not eligible to receive venlafaxine) on cognition in TRD patients. In a pre-defined secondary analysis of a multi-site, open-label trial, patients with TRD were randomly assigned to aripiprazole augmentation, rTMS augmentation, or switching to venlafaxine XR/duloxetine in 1:1:1 ratio and they were treated for 8 weeks. Cognition was assessed using the Cognitive and Physical Functioning Questionnaire (CPFQ). A mixed-effects model with repeated measures was conducted. Among the 258 randomized subjects with at least one post-baseline CPFQ assessment (aripiprazole n = 91; rTMS = 70;venlfaxine XR/duloxetine = 97), neither aripiprazole nor rTMS demonstrated significant differences compared to the venlafaxine XR/duloxetine switch group in cognitive outcome as measured by CPFQ scale (p > 0.025). The mean (SE) change in CPFQ scores from baseline to Week 8 was -8.04 (0.77) (aripiprazole augmentation) versus -6.70 (0.75) (venlafaxine XR/duloxetine switch), and - 8.81 (0.64) (rTMS augmentation) versus -6.72 (0.55) (venlafaxine XR/duloxetine switch). Hedge's g values were 0.21 for aripiprazole augmentation versus switching to venlafaxine XR/duloxetine and 0.33 for rTMS augmentation versus switching to venlafaxine XR/duloxetine. Although rTMS augmentation did not reach a statistically significant difference in subjective cognitive improvement, it showed a larger effect size compared to aripiprazole augmentation. Our findings signal that rTMS augmentation may offer a well-tolerated strategy for improving cognition in TRD.

01 Nov 2025·JOURNAL OF AFFECTIVE DISORDERS

Uncovering safety signals of duloxetine: Real-world evidence from the FAERS database

Article

Author: Qiu, Linghe ; Liu, Dan ; Zhou, Zhenhe ; Li, Na ; Liu, Liang ; Wu, Jianhong

Duloxetine, a widely used antidepressant, has not been adequately studied for its long-term adverse effects. This study aims to characterize the long-term safety of duloxetine in the real world. FAERS data from Q1 2004 to Q3 2024 were retrieved, covering adverse event (AEs) reports related to duloxetine. The data were analyzed using algorithms such as ROR, PRR, BCPNN, and MGPS. A total of 4876 AEs were collected, involving 52,205 patients. The top three System Organ Classes (SOCs) were psychiatric disorders, nervous system disorders, and general disorders and administration site conditions. The top three preferred terms based on signal strength were dysphoria (n = 2316, ROR 211.37, PRR 209.43, IC 6.73, EBGM 105.95), telangiectasia congenital (n = 5, ROR 96.55, PRR 96.55, IC 6.06, EBGM 66.69), and affect lability (n = 2520, ROR 85.2, PRR 84.35, IC 5.92, EBGM 60.66). In addition to the AEs already mentioned in the drug label, our study identified unexpected AEs related to congenital, familial and genetic disorders, such as telangiectasia congenital, factor X deficiency, and hemoglobinopathy, emphasizing the safety risks of duloxetine exposure during pregnancy. Furthermore, we observed rare adverse reaction signals, such as phagophobia, lymphocytic oesophagitis, coma blister, and junctional ectopic tachycardia. Notably, female patients reported more cases of drug withdrawal syndrome and opsoclonus myoclonus, while male patients more frequently reported sleep sex, sensory disturbance, semenuria, paedophilia, affect lability, and activation syndrome. Duloxetine may pose an undiscovered risk of AEs related to congenital, familial and genetic disorders. Our findings provide healthcare professionals with evidence to weigh the risks and benefits of duloxetine treatment, particularly for patients of different genders. Further prospective studies are needed to explore rare and unexpected AEs.

News (Medical) associated with Duloxetine Hydrochloride

29 Aug 2025

·www.einpresswire.com

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

16 Aug 2025

·pharma.economictimes.indiatimes.com

US FDA approves Tonix Pharma's drug to manage pain related to chronic condition

Bengaluru: The U.S. Food and Drug Administration has approved Tonix Pharmaceuticals ' drug to manage pain related to a type of chronic condition called fibromyalgia, the company said on Friday. The approval paves the way for the drug to be the first new treatment option in over 15 years for patients with fibromyalgia, which causes widespread pain, fatigue as well as problems with sleep and memory. Patients have so far relied on older drugs such as Lyrica, Cymbalta and AbbVie's Savella. The non-opioid drug , which will be sold under the brand name Tonmya , is a pill designed for bedtime treatment to improve sleep quality and reduce pain associated with the chronic condition. "This is the first time that a drug has been developed to target the non-restorative sleep, which we think plays an important role in fibromyalgia," CEO Seth Lederman said in an interview with Reuters ahead of the decision. Tonix's application to the health regulator was based on two late-stage studies, in which the drug significantly reduced daily pain compared to placebo at 14 weeks. Fibromyalgia has long been misunderstood and dismissed by doctors but is now widely recognized, with millions of patients being diagnosed with the condition. The drug in the studies showed side-effects of numbness of the tongue or mouth, which was related to dosing that led to the discontinuation of one patient in each study. "At present, there is a gap or room for more treatment options in terms of fibromyalgia treatment ," said Syed Alam, a rheumatology specialist at Houston Methodist. He added that the currently available medication options have limited effectiveness. This represents a big opportunity for Tonix, said David Bautz, a Zacks Small-Cap Research analyst, who estimates peak U.S. sales at $800 million for the drug after seven to eight years post launch. Tonix said the drug will be available by the fourth quarter. (Reporting by Siddhi Mahatole, Sriparna Roy and Christy Santhosh in Bengaluru; Editing by Vijay Kishore and Shreya Biswas)

Drug ApprovalClinical Result

15 Aug 2025

·www.fiercepharma.com

With FDA nod, Tonix's Tonmya becomes first new fibromyalgia treatment in more than 16 years

An FDA approval for Tonix Pharmaceuticals' Tonmya makes it the first new medication for fibromyalgia in more than 16 years. Tonix Pharmaceuticals was founded in 2010 to develop and bring to market a drug for fibromyalgia. Fifteen years later, the New Jersey company has accomplished its mission with the FDA's endorsement of a new treatment for the painful chronic condition. The U.S. regulator’s green light covers first-in-class Tonmya (cyclobenzaprine HCl), which Tonix formulated as a once-daily bedtime treatment taken under the tongue for rapid absorption into the bloodstream. Tonmya marks the first new medicine approved for fibromyalgia in more than 16 years.“I’ve been working on this particular idea for more than 25 years,” Seth Lederman, Tonix’s CEO and co-founder, said in an interview with Fierce. “It’s a very hard condition to study and that’s why we’re so excited to finally be at the end.”The approval came after market close on Friday, but in the last few days, Tonix’s share price has increased by more than 10% in anticipation of the approval. The first three non-opioid drugs for fibromyalgia—Pfizer’s Lyrica, Eli Lilly’s Cymbalta and AbbVie’s Savella—were approved in a rapid-fire span of 19 months starting in 2007. Since then, there have been no non-opioid advancements in the treatment of the disorder, which primarily affects women.As a tertiary amine cyclic, Tonmya offers a new mechanism of action by targeting the nonrestorative sleep associated with fibromyalgia, as opposed to treating symptoms of the disease. While anticonvulsant Lyrica reduces pain signals sent to the brain, serotonin-norepinephrine reuptake inhibitors (SNRIs) Cymbalta and Savella affect brain chemistry, relieving depression and anxiety.Tonix has had a bumpy ride in its development of Tonmya, with two phase 3 successes sandwiched around a late-stage failure in 2023 to relieve pain in patients with fibromyalgia-type long COVID.Facilitating the approval were the two successful studies, which included nearly 1,000 patients. Across both trials, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, succeeding on the studies' primary endpoint. Additionally, a greater percentage of study participants taking Tonmya achieved a clinically meaningful 30% or better improvement in their pain after three months, when compared to placebo.The key advantage for Tonmya over other approved treatments is its sublingual delivery, which “is is designed to reduce pain quickly and durably with a tolerable safety profile," Andrea Chadwick, M.D., of the University of Kansas Health System, said in a statement accompanying Tonix's approval announcement. “Treatments that are processed through the liver can result in metabolites that could affect a medicine’s efficacy and safety over time,” she said.For now, Tonix plans to market Tonmya itself and will add 70 sales reps to its current staff of 10. Tonix also markets two migraine products which it acquired in 2023. The company has not yet announced what it will charge for Tonmya. “Our approach is to be flexible, see what works, what doesn’t work,” Lederman said during the interview. “We do believe that this could be—maybe should be—a big pharma drug. But we’ve also seen that the trend in the industry is that more and more—particularly in the [central nervous system] space—that companies have to launch the drug themselves.”The company will target the 3 million people in the U.S. who have been diagnosed with fibromyalgia. But a larger population awaits as epidemiology studies indicate that there are roughly 7 million others in the U.S. who have the disorder and who have not been identified.Developing TonmyaTonix’s approach to finding a treatment traces back 50 years, when Canadian psychologist Harvey Moldofsky suggested that fibromyalgia was more a sleep disorder than a pain issue.“It was an audacious proposal,” Lederman said. “But he was the inspiration for us to pursue sleep quality as a target of therapy. I do think that people with fibromyalgia will recognize that pain and sleep have a vicious cycle. It’s self-reinforcing: Bad sleep, worse pain. Worse pain, worse sleep.” Tonmya is a repurposed version of cyclobenzaprine, a muscle relaxant which Merck gained approval for in 1977. The company later tested it for fibromyalgia. While the molecule showed initial effectiveness for patients, cyclobenzaprine’s benefits faded over time and Merck discontinued the program.“Instead of looking at is as the glass is half empty, we looked at it as the glass is half full,” Lederman said. “We took that and said, ‘How do we engineer this and get something that will have durability?”Tonix did that by converting the treatment from a pill to a sublingual formulation. In 2010, Jazz Pharmaceuticals failed in its attempt to gain an FDA nod to treat fibromyalgia with its sleep treatment Xywav, which was later approved for narcolepsy and hypersomnia.The failures and triumphs have combined to shed more light on the often-misunderstood disorder, giving patients more reason to explore treatment options.“There used to be a thing, doctors saying fibromyalgia doesn’t exist, it’s just women complaining—all these kind of stereotypes, tropes if you will,” Lederman said. “At the [International Association for the Study of Pain conference] last year, fibromyalgia was the plenary session. Fibromyalgia has arrived and now we hopefully have a next-generation, first-in-class product to address it with better tolerability.”

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Duloxetine Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D01179	Duloxetine Hydrochloride	N06AX21	DB00476

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Osteoarthritis	Japan	Shionogi & Co., Ltd.	19 Dec 2016
Low Back Pain	Japan	Shionogi & Co., Ltd.	18 Mar 2016
Diabetic peripheral neuropathy	United States	Eli Lilly & Co.	16 Oct 2014
Chronic Pain	Brazil	Libbs Farmacêutica Ltda.	24 Sep 2012
Diabetic Neuropathies	Japan	Shionogi & Co., Ltd.	22 Feb 2012
Chronic musculoskeletal pain	United States	Eli Lilly & Co.	04 Nov 2010
Fibromyalgia	United States	Eli Lilly & Co.	13 Jun 2008
Anxiety Disorders	Australia	Eli Lilly & Co.	14 Mar 2007
Neuralgia	Australia	Eli Lilly & Co.	14 Mar 2007
Depressive Disorder	China	Eli Lilly & Co.	28 Jul 2006
Generalized anxiety disorder	European Union	Eli Lilly Nederland BV	17 Dec 2004
Generalized anxiety disorder	European Union	Esteve Pharmaceuticals SA	17 Dec 2004
Generalized anxiety disorder	Iceland	Eli Lilly Nederland BV	17 Dec 2004
Generalized anxiety disorder	Iceland	Esteve Pharmaceuticals SA	17 Dec 2004
Generalized anxiety disorder	Liechtenstein	Eli Lilly Nederland BV	17 Dec 2004
Generalized anxiety disorder	Liechtenstein	Esteve Pharmaceuticals SA	17 Dec 2004
Generalized anxiety disorder	Norway	Eli Lilly Nederland BV	17 Dec 2004
Generalized anxiety disorder	Norway	Esteve Pharmaceuticals SA	17 Dec 2004
Diabetic peripheral neuropathic pain	European Union	Eli Lilly Nederland BV	11 Aug 2004
Diabetic peripheral neuropathic pain	Iceland	Eli Lilly Nederland BV	11 Aug 2004

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic osteoarthritis	Phase 3	Japan	Shionogi, Inc.	01 Oct 2014
Chronic osteoarthritis	Phase 3	Japan	Eli Lilly & Co.	01 Oct 2014
Patellofemoral Pain Syndrome	Phase 3	United States	Eli Lilly & Co.	01 Nov 2009
Patellofemoral Pain Syndrome	Phase 3	Puerto Rico	Eli Lilly & Co.	01 Nov 2009
Obesity	Phase 3	United States	Eli Lilly & Co.	01 Sep 2009
Multiple Sclerosis	Phase 3	United States	Eli Lilly & Co.	01 Oct 2008
Multiple Sclerosis	Phase 3	Belgium	Eli Lilly & Co.	01 Oct 2008
Multiple Sclerosis	Phase 3	Canada	Eli Lilly & Co.	01 Oct 2008
Multiple Sclerosis	Phase 3	Poland	Eli Lilly & Co.	01 Oct 2008
Osteoarthritis, Knee	Phase 3	United States	Eli Lilly & Co.	01 Nov 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04137107 (Alliance A221805, ASCO2025)	Phase 2	Peripheral Nervous System Diseases	199	Duloxetine 30mg	zwfqhuitir(gqdttwohsm) = Fatigue (51.9%) was the most common solicited adverse event tonfvhtfmd (eqnlcfdirm ) View more	Negative	30 May 2025
				Duloxetine 60mg
NCT04395001 (PRECICE, CTgov)	Phase 4	Chronic Pain	280	Nurse-delivered Motivational Interviewing+duloxetine (Behavioral Intervention, Nurse Support Plus Medication)	rmuhoadbmv(bjjcztcwml) = ojycuyxuoe yslhrcfrlf (jpdvtjuiaf, 1.6) View more	-	29 Apr 2025
				Web-based Cognitive Behavioral Therapy (CBT)+duloxetine (Behavioral Intervention Plus Medication)	rmuhoadbmv(bjjcztcwml) = oatypyrjmq yslhrcfrlf (jpdvtjuiaf, 2.1) View more
NCT03575403 (BED[IN]:36, CTgov)	Phase 1	Alcohol Use Disorder	19	Alcohol+Methylphenidate (Placebo)	wlovrjbolk(czqwwhmlnp) = syjnmnhzfx mguukssmxj (zojnazvfdd, jahheoksvn - jidbsgtvzl) View more	-	10 Apr 2025
				Duloxetine (60 MG) (Duloxetine (60 MG))	wlovrjbolk(czqwwhmlnp) = saybtjdgjg mguukssmxj (zojnazvfdd, zwdorzlenm - fxunmegxwz) View more
NCT03249558 (Duloxetine, CTgov)	Phase 4	Low Back Pain \| Chronic Pain \| Neck Pain	81	Duloxetine+Morphine (Morphine, Duloxetine)	aviqtjcayd(vdqogblpvl) = mdztkzrfyh eytkpwizfi (ghpupamosw, 2.05) View more	-	14 Nov 2024
				Placebo+Morphine (Morphine, Placebo Duloxetine)	aviqtjcayd(vdqogblpvl) = rgqygzggah eytkpwizfi (ghpupamosw, 2.16) View more
NCT04313335 (PROCESS Trial, Pubmed \| Clin Infect Dis)	Not Applicable	Neuralgia, Postherpetic \| Herpes Zoster	-	Duloxetine	wvrbispbkd(gqjbpcmjdk) = soskvboqyu dnrcmutiml (jylggnjenn )	-	10 Apr 2024
				Duloxetine (Control)	wvrbispbkd(gqjbpcmjdk) = llkaexyhpz dnrcmutiml (jylggnjenn )
NCT02229825 (CTgov)	Phase 4	Depressive Disorder, Major	339	Duloxetine (60 mg Duloxetine)	arnshmhfbt(wbdjfcpmut) = xsqddcvinw ntbnyiwsho (hbfiaqflbn, 10.6) View more	-	23 Oct 2023
				Duloxetine (120 mg Duloxetine)	arnshmhfbt(wbdjfcpmut) = vpetklhbly ntbnyiwsho (hbfiaqflbn, 10.0) View more
NCT03395353 (Pubmed \| Drug Metab Pharmacokinet)	Phase 3	Depressive Disorder, Major	151	duloxetine (Japanese pediatric patients with major depressive disorder)	udwqdvkkcb(zjqeulbzfb) = eknjavgmqk raoffrgogg (owjtcilliu ) View more	-	15 Feb 2023
NCT04178993 (CTgov)	Phase 1	Methamphetamine dependence	8	Placebo oral capsule+Methylphenidate+Methamphetamine (Placebo Comparator: Placebo)	ipwtnaglcd(omzvyufpuv) = vbczfhuksj pmvietgxbp (chchkgdxzk, 0) View more	-	09 Jan 2023
				Placebo oral capsule+Methylphenidate+Duloxetine+Methamphetamine (Active Comparator: Duloxetine)	znjajyjgub(evwnzyqjcd) = lvcrycgwqw qbuydfcdwc (lpxfdxvnez, 0) View more
CTRI/2021/03/031875 (Pubmed \| Pain Med)	Not Applicable	Pain	82	Duloxetine	pacpvivwut(oerbijqwcc) = fhobfobnbw ltuzeixntd (cdnnkgvlwe )	Positive	21 Nov 2022
				Placebo	pacpvivwut(oerbijqwcc) = pdvoruhoks ltuzeixntd (cdnnkgvlwe )
NCT03271151 (CTgov)	Phase 4	Joint Diseases \| Acute Pain \| Chronic Pain	160	Cymbalta (Duloxetine ("Cymbalta"))	nscgjqcifu(bkokuahpxl) = sxillhhnos qtqqvqpxpo (sdmlxtzusf, 226) View more	-	26 Apr 2022
				Placebo (Placebo)	nscgjqcifu(bkokuahpxl) = ooannhacry qtqqvqpxpo (sdmlxtzusf, 374) View more

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