Fibromyalgia

43
Pipeline Programs
24
Companies
50
Clinical Trials
1 recruiting
8
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
10
2
19
11
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2100%
+ 46 programs with unclassified modality

On Market (8)

Approved therapies currently available

Eli Lilly and Company
CYMBALTAApproved
duloxetine hydrochloride
Eli Lilly and Company
oral2008
U
DULOXETINE HYDROCHLORIDEApproved
duloxetine hydrochloride
Unknown Company
oral2019
U
LUMRYZApproved
sodium oxybate
Unknown Company
oral2023
U
LYRICAApproved
pregabalin
Unknown Company
oral2004
U
PREGABALINApproved
pregabalin
Unknown Company
oral2020
U
SODIUM OXYBATEApproved
sodium oxybate
Unknown Company
oral
Jazz Pharmaceuticals
XYREMApproved
sodium oxybate
Jazz Pharmaceuticals
oral2002
U
ZONEGRANApproved
zonisamide
Unknown Company
Anti-epileptic Agent [EPC]oral2000

Competitive Landscape

22 companies ranked by most advanced pipeline stage

Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
5 programs
1
3
1
duloxetine hydrochloridePhase 41 trial
DuloxetinePhase 31 trial
DuloxetinePhase 31 trial
duloxetinePhase 31 trial
pramipexole ERPhase 21 trial
Active Trials
NCT00689052Terminated61
NCT00190866Completed210Est. Jun 2007
NCT00233025Completed320Est. Jun 2007
+2 more trials
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
4 programs
3
1
DuloxetinePhase 3
DuloxetinePhase 3
CYMBALTA(duloxetine)Phase 35 trials
Treatment for FibromyalgiaN/A1 trial
Active Trials
NCT00725101Completed1,700Est. Apr 2011
NCT03395353Terminated151Est. Jul 2020
NCT03315793Completed149Est. Nov 2019
+3 more trials
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
4 programs
1
3
1
Sodium OxybatePhase 31 trial
Xyrem®Phase 31 trial
Xyrem®Phase 31 trial
XyremPhase 21 trial
Active Trials
NCT00087555Completed195Est. Jan 2006
NCT00803023Completed129
NCT00423605Completed560Est. Jan 2010
+1 more trials
Verona Pharma
Verona PharmaUK - London
2 programs
1
micronized and ultra-micronized PalmitoylethanolamidePhase 41 trial
LIMFA Therapy®N/A1 trial
Active Trials
NCT03503760Completed48Est. Jul 2017
NCT04488926CompletedEst. May 2022
E
EisaiChina - Liaoning
1 program
1
zonisamidePhase 41 trial
Active Trials
NCT00259636Withdrawn0Est. Jan 2008
Pfizer
PfizerNEW YORK, NY
8 programs
1
2
3
PregabalinPhase 31 trial
[S,S]-ReboxetinePhase 35 trials
[S,S]-reboxetinePhase 31 trial
DVS-233Phase 2/31 trial
Desvenlafaxine Sustained ReleasePhase 2/35 trials
+3 more programs
Active Trials
NCT00819624CompletedEst. Mar 2009
NCT01203865Unknown1,200Est. Mar 2012
NCT00752505Completed89Est. Jun 2009
+13 more trials
Tonix Pharmaceuticals
Tonix PharmaceuticalsBERKELEY HEIGHTS, NJ
5 programs
5
TNX-102 SLPhase 31 trial
TNX-102 SLPhase 31 trial
TNX-102 SL Tablet, 2.8 mgPhase 31 trial
TNX-102 SL Tablet, 2.8mgPhase 31 trial
TNX-102 SL Tablet, 5.6 mgPhase 31 trial
Active Trials
NCT04172831Completed503Est. Oct 2020
NCT04508621Completed514Est. Nov 2021
NCT02829814Terminated51Est. Sep 2016
+2 more trials
Axsome Therapeutics
Axsome TherapeuticsNY - New York
1 program
1
AXS-14Phase 31 trial
Active Trials
NCT07398417Recruiting620Est. Mar 2028
DS
Daiichi SankyoChina - Shanghai
1 program
1
DS-5565Phase 31 trial
Active Trials
NCT02496884Completed56Est. Jul 2017
Providence Therapeutics
2 programs
1
Stress and EmotionsPhase 21 trial
Affective Self-Awareness workshopN/A1 trial
Active Trials
NCT00437411CompletedEst. Nov 2008
NCT01287481CompletedEst. Jul 2015
UP
UCB PharmaBelgium - Brussels
2 programs
1
rozanolixizumabPhase 2Monoclonal Antibody1 trial
LevetiracetamN/A1 trial
Active Trials
NCT00254657Completed66Est. Apr 2005
NCT05643794Completed63Est. Jul 2024
Astellas
AstellasChina - Shenyang
1 program
1
ASP8062Phase 21 trial
Active Trials
NCT03092726Completed183Est. Mar 2018
Teva
TevaIsrael - Petach Tikva
1 program
1
FremanezumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT03965091Terminated189Est. Jan 2022
M&
Merck & Co.RAHWAY, NJ
1 program
1
Ibutamoren MesylatePhase 21 trial
Active Trials
NCT00116129Completed64Est. Apr 2008
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
1 program
1
Operant behavioral treatment; Drug: THCPhase 21 trial
Active Trials
NCT00176163Completed240Est. May 2009
City Therapeutics
City TherapeuticsMA - Cambridge
1 program
1
Operant behavioral treatment; Drug: THCPhase 2
Alliance Pharmaceuticals
2 programs
1
HRG 80 Red GinsengPhase 11 trial
Recovery FactorsN/A2 trials
Active Trials
NCT04381780Completed100Est. Jan 2021
NCT04381793Completed43Est. Jul 2020
NCT04599348Unknown70Est. Apr 2021
Trace Biosciences
Trace BiosciencesOR - Beaverton
2 programs
Interoceptive accuracy measurementN/A1 trial
Interoceptive accuracy measurementN/A1 trial
Active Trials
NCT05907538UnknownEst. Jun 2024
NCT05907590UnknownEst. Dec 2023
Abbott
AbbottABBOTT PARK, IL
1 program
Occipital StimulationN/A1 trial
Active Trials
NCT01298609Completed40Est. Jan 2013
Jerusalem Pharmaceuticals
Jerusalem PharmaceuticalsIsrael - Ramallah
1 program
TetrahydrocannabinolN/A1 trial
Active Trials
NCT01149018Unknown80Est. Oct 2012
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
The Savella Pregnancy RegistryN/A1 trial
Active Trials
NCT01026077Terminated350Est. Oct 2024
Ferring Pharmaceuticals
Ferring PharmaceuticalsArgentina - Buenos Aires
1 program
VSL#3N/A1 trial
Active Trials
NCT04256785Completed110Est. May 2020

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Verona Pharmamicronized and ultra-micronized Palmitoylethanolamide
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine
Boehringer Ingelheimduloxetine hydrochloride
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine
Eli Lilly and Companyduloxetine

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 20,506 patients across 50 trials

NCT04488926Verona Pharmamicronized and ultra-micronized Palmitoylethanolamide

Micronized and Ultramicronized Palmitoylethanolamide in Fibromyalgia Patients

Start: Jul 2020Est. completion: May 2022
Phase 4Completed

A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP)

Start: Apr 2015Est. completion: May 2017304 patients
Phase 4Completed

Inflammatory Markers and Cognitive Function in Major Depression

Start: Jul 2011Est. completion: Aug 201320 patients
Phase 4Unknown

A Study of Duloxetine in Elderly Generalized Anxiety Disorder

Start: Oct 2010Est. completion: Jul 2012291 patients
Phase 4Completed

A Study in Depression and Associated Painful Physical Symptoms

Start: Mar 2010Est. completion: Mar 2011527 patients
Phase 4Completed

A Study for Adolescents With Fibromyalgia Syndrome

Start: Mar 2010Est. completion: Aug 20100
Phase 4Withdrawn

A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms

Start: Nov 2009Est. completion: Oct 2010528 patients
Phase 4Completed

Duloxetine for Major Depression in Peri-/Postmenopausal Women

Start: May 2009Est. completion: Jun 201270 patients
Phase 4Unknown

Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression

Start: Dec 2008Est. completion: Dec 201417 patients
Phase 4Completed

Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder

Start: Nov 2008Est. completion: Mar 2010840 patients
Phase 4Completed

Switching to Duloxetine in Patients With Depression

Start: Jun 2008Est. completion: Jul 2009242 patients
Phase 4Completed
NCT00673452Boehringer Ingelheimduloxetine hydrochloride

A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia

Start: Jun 2008Est. completion: Jul 2009530 patients
Phase 4Completed

A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients

Start: Sep 2007Est. completion: Dec 2008776 patients
Phase 4Completed

Study of Brain Response to Emotional Pictures Using a fMRI While on Duloxetine

Start: Sep 2007Est. completion: Apr 200910 patients
Phase 4Completed

Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease

Start: Mar 2007Est. completion: Jul 2009151 patients
Phase 4Completed

Duloxetine for Perimenopausal Depression

Start: Feb 2007Est. completion: Jun 20087 patients
Phase 4Completed

An Open-Label Trial of Duloxetine for the Treatment of Irritable Bowel Syndrome

Start: Nov 2006Est. completion: Feb 200815 patients
Phase 4Completed

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Start: Nov 2006Est. completion: Apr 20096 patients
Phase 4Terminated

Study of Duloxetine vs Placebo in Treatment of Binge Eating Disorder With Depression

Start: Oct 2006Est. completion: Oct 200940 patients
Phase 4Completed

The Efficacy and Tolerability of Duloxetine for the Treatment of Panic Disorder

Start: Aug 2006Est. completion: Jan 200915 patients
Phase 4Completed

Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome

Start: Apr 2006Est. completion: May 200922 patients
Phase 4Completed

An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache

Start: Apr 2006Est. completion: Mar 200730 patients
Phase 4Completed

Duloxetine Treatment in Elderly With Dysthymia

Start: Jan 2006Est. completion: Mar 201330 patients
Phase 4Completed

Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)

Start: Dec 2005Est. completion: Dec 201320 patients
Phase 4Completed

Tolerability of Switching to Duloxetine for the Management of Diabetic Nerve Pain

Start: Dec 2005Est. completion: Apr 2007205 patients
Phase 4Completed

A Pilot Study Assessing Duloxetine's Efficacy in Atypical Depression

Start: Mar 200520 patients
Phase 4Completed

A Comparison of Tolerability and Efficacy of Different Doses of Duloxetine for the Treatment of Major Depressive Disorder

Start: Oct 2004Est. completion: Jan 2006640 patients
Phase 4Completed

A Single-Blind Placebo Run-in Study of Duloxetine for Activity-Limiting Osteoarthritis Pain

Start: Sep 2004Est. completion: Feb 200725 patients
Phase 4Completed

Zonisamide for Fibromyalgia & Migraine

Start: Aug 2004Est. completion: Jan 20080
Phase 4Withdrawn

Lilly's Emotional and Physical Symptoms of Depression Study (LEAPS)

Start: Aug 2004Est. completion: Jan 20058,000 patients
Phase 4Completed

Switching to Duloxetine From Other Antidepressants

Start: Aug 2004Est. completion: Mar 2006360 patients
Phase 4Completed

Duloxetine Versus Duloxetine Plus Non-Drug Therapy for Depression

Start: Feb 2004Est. completion: Jun 2005940 patients
Phase 4Completed

Duloxetine vs. Active Comparator in the Treatment of Patients With Depression

Start: Jul 2003Est. completion: May 2004320 patients
Phase 4Completed

Duloxetine vs. Active Comparator for the Treatment of Depression

Start: Apr 2003Est. completion: Mar 2004480 patients
Phase 4Completed

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Start: Jan 2026Est. completion: Mar 2028620 patients
Phase 3Recruiting
NCT05273749Tonix PharmaceuticalsTNX-102 SL Tablet, 5.6 mg

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

Start: Apr 2022Est. completion: Nov 2023457 patients
Phase 3Completed

A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

Start: Jul 2020Est. completion: Nov 2021514 patients
Phase 3Completed

A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

Start: Dec 2019Est. completion: Oct 2020503 patients
Phase 3Completed

A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder

Start: Jan 2018Est. completion: Jul 2020151 patients
Phase 3Terminated

A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder

Start: Dec 2017Est. completion: Nov 2019149 patients
Phase 3Completed
NCT02829814Tonix PharmaceuticalsTNX-102 SL Tablet, 2.8 mg

Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

Start: Jul 2016Est. completion: Sep 201651 patients
Phase 3Terminated

Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease

Start: Jun 2015Est. completion: Jul 201756 patients
Phase 3Completed
NCT02436096Tonix PharmaceuticalsTNX-102 SL Tablet, 2.8mg

A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

Start: Apr 2015Est. completion: Sep 2016519 patients
Phase 3Completed

An Extension Study of Duloxetine in Osteoarthritis and Knee Pain (Extension of F1J-JE-HMGX, NCT02248480)

Start: Jan 2015Est. completion: Mar 201693 patients
Phase 3Completed

A Study of Duloxetine (LY248686) in Participants With Chronic Osteoarthritis and Knee Pain in Japan

Start: Oct 2014Est. completion: Jun 2015354 patients
Phase 3Completed

A Study of Duloxetine in Participants With Chronic Pain Due to Osteoarthritis in China

Start: Sep 2013Est. completion: Jun 2015407 patients
Phase 3Completed

An Open Label Extension Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

Start: Sep 2013Est. completion: Dec 2014151 patients
Phase 3Completed

A Study of Duloxetine (LY248686) in Participants With Chronic Low Back Pain

Start: May 2013Est. completion: Jul 2014458 patients
Phase 3Completed

An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)

Start: Jun 2012Est. completion: Feb 2014149 patients
Phase 3Completed

A Study of Duloxetine in Fibromyalgia

Start: Mar 2012Est. completion: Dec 2013393 patients
Phase 3Completed

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

19 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 20,506 patients
24 companies competing in this space