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Chronic Spontaneous Urticaria

Dermatology
33
Pipeline Programs
19
Companies
48
Clinical Trials
6 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
0
11
0
15
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2480%
Small Molecule
620%
+ 33 programs with unclassified modality

Dermatology is a $292M market that is mature and consolidating, dominated by a single blockbuster approaching loss of exclusivity.

$0.292B marketMature→ Stable30 products15 companies

Key Trends

  • HUMIRA (adalimumab) dominates 88% of market spending but faces LOE in near-term, creating vulnerability
  • Novel mechanisms like aryl hydrocarbon receptor agonists gaining traction with emerging products in peak lifecycle
  • Substantial clinical trial activity (812 trials) suggests ongoing innovation pipeline despite mature market

Career Verdict

Dermatology offers stable near-term opportunities but requires strategic positioning given patent cliff risk and limited market size compared to other therapeutic areas.

AI-generated market analysis based on FDA, CMS, ClinicalTrials.gov, and hiring data

Market Leaders

#1HUMIRADeclining
$258M
AbbVie·LOE_APPROACHING
#2VTAMAGrowing
$19M
Merck & Co.·PEAK13.5yr
#3ORACEADeclining
$4M
Galderma·LOE_APPROACHING1.6yr

Drug Class Breakdown

Unknown Mechanism (predominantly HUMIRA)
$258M(88%)

Patent cliff looming

Aryl Hydrocarbon Receptor Agonists
$19M(6%)

Emerging innovation

Retinoids and Derivatives
$3M(1%)

Mature segment

Other Mechanisms
$12M(4%)

Niche applications

Career Outlook

Stable

Dermatology represents a stable but narrow career path with limited growth compared to larger therapeutic areas; compensation is competitive in Commercial and Medical Affairs but R&D opportunities are scarce. HUMIRA's patent cliff creates near-term uncertainty for AbbVie but may drive restructuring and new product launches elsewhere. Market consolidation around a few large players (AbbVie, Regeneron, Merck) limits startup/biotech opportunities.

Breaking In

Enter via Commercial or Medical Affairs roles where hiring is highest; dermatology has lower scientific barrier to entry than oncology but requires strong relationship-building and market access acumen.

For Experienced Professionals

Leverage HUMIRA transition expertise or develop specialty in emerging mechanisms (retinoids, AhR agonists); consider moving to larger franchises (immunology, oncology) if seeking higher growth trajectory.

In-Demand Skills

Health Economics & Outcomes Research (HEOR)Dermatology Clinical KnowledgeSales Strategy & Account ManagementDigital Health / Telemedicine IntegrationMedical Writing for Topicals & Systemics

Best For

Regional Sales ManagerMedical Science Liaison (MSL)Product Manager (Post-Launch)Health Economics ManagerRegulatory Affairs Specialist

Hiring Landscape

$85K-$386K

Dermatology shows concentrated hiring at AbbVie (52 positions) and Regeneron (46 positions), with Commercial roles dominating (89 jobs, $188K avg salary) and Medical Affairs roles commanding premium compensation ($386K avg). Limited R&D hiring (8 positions) suggests mature drug development phase with emphasis on commercialization and market access.

173
Open Roles
3
Companies Hiring
3
Departments

Top Hiring Companies

53Growing
46Growing
14Stable

By Department

Commercial(51%)
$188K
Medical Affairs(24%)
$386K
Research & Development(5%)

Commercial and Medical Affairs roles offer strong compensation and growth, but overall job market is small; best for professionals seeking revenue-generating functions rather than discovery roles.

On Market (1)

Approved therapies currently available

Novartis
RHAPSIDOApproved
remibrutinib
Novartis
Kinase Inhibitor [EPC]oral2025

Competitive Landscape

19 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
28 programs
1
5
14
1
OMALIZUMABPhase 4Monoclonal Antibody1 trial
LOU064Phase 31 trial
LOU064Phase 31 trial
LOU064Phase 31 trial
LOU064Phase 31 trial
+23 more programs
Active Trials
NCT07408219Recruiting350Est. Mar 2026
NCT06991608Active Not Recruiting116Est. Dec 2025
NCT04903613No Longer Available
+25 more trials
Novartis
NovartisBASEL, Switzerland
11 programs
1
Collection of patient dataN/A
LigelizumabN/AMonoclonal Antibody
RemibrutinibN/ASmall Molecule
XolairN/A
LOU064PHASE_2
+6 more programs
Highlightll Pharmaceutical
2 programs
1
1
TLL-018 tabletsPhase 31 trial
TLL018 tabletsPhase 11 trial
Active Trials
NCT05373355Completed41Est. Sep 2023
NCT06396026Recruiting436Est. Dec 2027
Longbio Pharma
Longbio PharmaChina - Shanghai
3 programs
2
1
LP-003Phase 21 trial
LP-003 200mgPhase 11 trial
LP-003 Dose 1Phase 11 trial
Active Trials
NCT06604949Active Not Recruiting12Est. Dec 2026
NCT06294288Completed60Est. Mar 2024
NCT06228560Completed202Est. Nov 2025
Prevail Therapeutics
1 program
1
LY3454738Phase 21 trial
Active Trials
NCT04159701Terminated52Est. Feb 2021
Escient Pharmaceuticals
1 program
1
Oral EP262Phase 21 trial
Active Trials
NCT06077773Terminated113Est. Jan 2025
Taiho Pharma
Taiho PharmaJapan - Tokyo
1 program
1
TAS5315 Dose 1Phase 21 trial
Active Trials
NCT05335499Completed126Est. Dec 2023
Kite Pharma
Kite PharmaCA - El Segundo
1 program
1
TirabrutinibPhase 2Small Molecule1 trial
Active Trials
NCT04827589Withdrawn0Est. Sep 2022
United BioPharma
United BioPharmaTaiwan - Hsinchu
1 program
1
UB-221Phase 21 trial
Active Trials
NCT05298215Unknown25Est. Dec 2023
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
NucalaPhase 1
Celldex Therapeutics
5 programs
CDX-0159PHASE_11 trial
barzolvolimabPHASE_2Monoclonal Antibody1 trial
barzolvolimabPHASE_3Monoclonal Antibody1 trial
barzolvolimabPHASE_3Monoclonal Antibody1 trial
barzolvolimabPHASE_3Monoclonal Antibody1 trial
Active Trials
NCT04538794Completed45Est. Jan 2023
NCT05368285Completed208Est. Dec 2024
NCT06445023Active Not Recruiting963Est. Apr 2027
+2 more trials
BeOne Medicines
BeOne MedicinesCA - San Carlos
1 program
BGB-16673PHASE_1
GSK
GSKLONDON, United Kingdom
1 program
NucalaPHASE_11 trial
Active Trials
NCT03494881Completed10Est. Feb 2025
Jasper Therapeutics
Jasper TherapeuticsREDWOOD CITY, CA
1 program
BriquilimabPHASE_1_2Monoclonal Antibody1 trial
Active Trials
NCT06162728Active Not Recruiting88Est. Oct 2026
IQVIA
IQVIADURHAM, NC
1 program
BenralizumabPHASE_2Monoclonal Antibody
SteroTherapeutics
SteroTherapeuticsPA - Doylestown
1 program
CBDPHASE_21 trial
Active Trials
NCT04439955Completed15Est. Jul 2021
Gilead Sciences
Gilead SciencesFOSTER CITY, CA
1 program
TirabrutinibPHASE_2Small Molecule
Celltrion
CelltrionKorea - Incheon
1 program
CT-P39PHASE_31 trial
Active Trials
NCT04426890Completed634Est. Apr 2023
Sanofi
SanofiPARIS, France
1 program
DupilumabPHASE_3Monoclonal Antibody1 trial
Active Trials
NCT05526521Completed15Est. Feb 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
SandozOMALIZUMAB
Celldex Therapeuticsbarzolvolimab
Highlightll PharmaceuticalTLL-018 tablets
Celldex Therapeuticsbarzolvolimab
Celldex Therapeuticsbarzolvolimab
SandozRemibrutinib
SandozLOU064
SandozLOU064
SandozLOU064
SanofiDupilumab
SandozLOU064
SandozLOU064
SandozLOU064 25 mg
CelltrionCT-P39
SandozLigelizumab

Showing 15 of 46 trials with date data

Clinical Trials (48)

Total enrollment: 17,519 patients across 48 trials

Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE Treatment

Start: Apr 2015Est. completion: Jan 2016136 patients
Phase 4Completed

Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Start: Nov 2025Est. completion: Sep 20281,370 patients
Phase 3Recruiting

A Study of Efficacy and Safety of TLL-018 in CSU Participants

Start: Dec 2024Est. completion: Dec 2027436 patients
Phase 3Recruiting

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (CSU)

Start: Jul 2024Est. completion: Apr 2027976 patients
Phase 3Active Not Recruiting

A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

Start: Jul 2024Est. completion: Apr 2027963 patients
Phase 3Active Not Recruiting
NCT06042478SandozRemibrutinib

Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.

Start: Nov 2023Est. completion: Jul 2027470 patients
Phase 3Active Not Recruiting

24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up

Start: Jul 2023Est. completion: Mar 2032100 patients
Phase 3Recruiting

A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.

Start: Apr 2023Est. completion: Apr 2024144 patients
Phase 3Completed

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

Start: Dec 2022Est. completion: Aug 2027696 patients
Phase 3Active Not Recruiting

A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)

Start: Aug 2022Est. completion: Feb 202515 patients
Phase 3Completed

A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines

Start: Jan 2022Est. completion: Dec 202371 patients
Phase 3Completed

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines

Start: Dec 2021Est. completion: Jan 2024455 patients
Phase 3Completed
NCT05030311SandozLOU064 25 mg

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines

Start: Nov 2021Est. completion: Jan 2024470 patients
Phase 3Completed

To Compare Efficacy and Safety of CT-P39 and EU-approved Xolair in Patients With Chronic Spontaneous Urticaria

Start: Dec 2020Est. completion: Apr 2023634 patients
Phase 3Completed

Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab

Start: Apr 2020Est. completion: Sep 20221,033 patients
Phase 3Terminated

A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- Antihistamines

Start: Apr 2019Est. completion: Jan 202266 patients
Phase 3Completed

A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.

Start: Oct 2018Est. completion: Jun 20221,078 patients
Phase 3Completed

A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Start: Oct 2018Est. completion: Jun 20221,072 patients
Phase 3Completed

Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria

Start: Apr 2017Est. completion: Sep 2019418 patients
Phase 3Completed

OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) Patients

Start: Aug 2014Est. completion: Nov 2016314 patients
Phase 3Completed

Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy

Start: Jan 2013Est. completion: May 201491 patients
Phase 3Completed

Efficacy and Safety of LP-003 in Patients With CSU Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Start: Jan 2024Est. completion: Nov 2025202 patients
Phase 2Completed

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria

Start: Sep 2023Est. completion: Jan 2025113 patients
Phase 2Terminated

A Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of UB-221 IV Infusion as an add-on Therapy in Patients With Chronic Spontaneous Urticaria

Start: Oct 2022Est. completion: Dec 202325 patients
Phase 2Unknown

A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria

Start: Jun 2022Est. completion: Dec 2023126 patients
Phase 2Completed

A Phase 2 Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Start: May 2022Est. completion: Dec 2024208 patients
Phase 2Completed

Study to Evaluate the Efficacy, Safety, and Tolerability of Tirabrutinib in Participants With Antihistamine-Resistant Chronic Spontaneous Urticaria

Start: Jul 2021Est. completion: Sep 20220
Phase 2Withdrawn

Study to Evaluate the Safety, Tolerability and Efficacy of Cannabidiol (CBD) as a Steroid-sparing Therapy in Chronic Spontaneous Urticaria (CSU) Patients

Start: Feb 2020Est. completion: Jul 202115 patients
Phase 2Completed

A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria

Start: Nov 2019Est. completion: Feb 202152 patients
Phase 2Terminated

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

Start: Oct 2019Est. completion: Sep 2022229 patients
Phase 2Completed
NCT03926611SandozLOU064 Arm 1

This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

Start: Jun 2019Est. completion: Apr 2021311 patients
Phase 2Completed

Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)

Start: Aug 2018Est. completion: Feb 202149 patients
Phase 2Completed

A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients

Start: May 2016Est. completion: May 2019226 patients
Phase 2Completed

Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU

Start: Jul 2015Est. completion: Jun 2017382 patients
Phase 2Completed

Dose Escalation Trial Of Safety, Pharmacokinetic/Pharmacodynamic And Preliminary Clinical Activity of Briquilimab In Adult Patients With Chronic Spontaneous Urticaria (CSU)

Start: Nov 2023Est. completion: Oct 202688 patients
Phase 1/2Active Not Recruiting

A Study of Single Dose of LP-003 in Healthy Adult Subjects

Start: Oct 2024Est. completion: Dec 202612 patients
Phase 1Active Not Recruiting

A Study of Single and Multiple Doses of LP-003 in Healthy Adult Participants

Start: Jul 2022Est. completion: Mar 202460 patients
Phase 1Completed

Safety and Efficacy of TLL018 in Patients With Chronic Spontaneous Urticaria.

Start: May 2022Est. completion: Sep 202341 patients
Phase 1Completed

A Study of CDX-0159 in Patients With Chronic Spontaneous Urticaria

Start: Sep 2020Est. completion: Jan 202345 patients
Phase 1Completed

Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria

Start: Aug 2020Est. completion: Jul 202211 patients
Phase 1Terminated

Mepolizumab for the Treatment of Chronic Spontaneous Urticaria

Start: Jul 2019Est. completion: Feb 202510 patients
Phase 1Completed
NCT05170724SandozRemibrutinib

Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria

N/AAvailable

Global Managed Access Program Cohort for Ligelizumab in CSU

N/ANo Longer Available
NCT07358364SandozRemibrutinib in Real-world Clinical Practice

Remibrutinib in Real-world Clinical Practice

Start: Feb 2026Est. completion: Oct 20313,280 patients
N/ARecruiting
NCT07358780SandozRemibrutinib in Real-world Clinical Practice - a US Sub-study

Remibrutinib in Real-world Clinical Practice - a US Sub-study

Start: Feb 2026Est. completion: Sep 2029505 patients
N/ARecruiting
NCT07408219SandozA Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients

A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients

Start: Jan 2026Est. completion: Mar 2026350 patients
N/ARecruiting
NCT06991608SandozCollection of patient data

A Study to Compare Digital Disease Monitoring of Patients With csU (Telemedicine to Face-to-Face Visits) in Germany

Start: Jun 2024Est. completion: Dec 2025116 patients
N/AActive Not Recruiting

A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in China

Start: Feb 2024Est. completion: Aug 202555 patients
N/ACompleted

Related Jobs in Dermatology

Phase Legend

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

Key Insights

15 late-stage (Phase 3) programs, potential near-term approvals
6 actively recruiting trials targeting 17,519 patients
19 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.