Moderate to Severe Inflammatory Acne Vulgaris Clinical Trials, 2025: 15+ Pipeline Drugs, Targeted Agents, and Immune-Modulating Strategies Drive Progress

DelveInsight's "Moderate to Severe Inflammatory Acne Vulgaris - Clinical Trials, 2025" reviews 15+ therapies in development for acne vulgaris, a chronic dermatologic disease marked by inflammation, sebum overproduction, and Cutibacterium acnes involvement. Companies such as Sagimet Biosciences, Boston Pharmaceuticals, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Botanix Pharmaceuticals, and Cutia Therapeutics are actively advancing candidates that address key unmet needs beyond conventional isotretinoin, antibiotics, and hormonal therapies.

The acne pipeline is expanding with innovative approaches, including sebum-suppressing small molecules, androgen receptor antagonists, topical fixed-dose combinations, and anti-inflammatory agents targeting JAK and cytokine pathways. Biologics and microbiome-modulating therapies are also being tested in severe, treatment-resistant phenotypes.

With multiple Phase II and III trials underway, the focus is shifting from long-term antibiotics to precision, immune-driven, and non-antibiotic regimens. As late-stage candidates progress, the treatment landscape for moderate to severe inflammatory acne is expected to evolve, offering safer and more effective options that improve both outcomes and patient quality of life.

Interested in learning more about the current treatment landscape and the key drivers shaping the moderate to severe inflammatory acne vulgaris pipeline? Click here: https://www.delveinsight.com/report-store/moderate-to-severe-inflammatory-acne-vulgaris-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Moderate to Severe Inflammatory Acne Vulgaris Pipeline Report
• DelveInsight's moderate to severe inflammatory acne vulgaris pipeline analysis depicts a strong space with 15+ active players working to develop 15+ pipeline drugs for moderate to severe inflammatory acne vulgaris treatment.
• The leading moderate to severe inflammatory acne vulgaris companies include Sagimet Biosciences, Boston Pharmaceuticals, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Botanix Pharmaceuticals, Cutia Therapeutics, Janssen Research & Development, LLC, Biofrontera Bioscience GmbH, Braintree Laboratories, and others are evaluating their lead assets to improve the Moderate to Severe Inflammatory Acne Vulgaris treatment landscape.
• Key moderate to severe inflammatory acne vulgaris pipeline therapies in various stages of development include TVB-2640, BOS 356, BTX 1503, FMX101, RA-18C3, ALA-PDT, BLI1100, and others.
• In June 2025, Ascletis (in China) reported that denifanstat (ASC40), a once-daily oral FASN inhibitor, met all primary, key secondary, and secondary endpoints in a Phase III trial for moderate-to-severe acne vulgaris (480 patients, 12-week treatment). It showed superior treatment success, lesion count reductions, and was generally well-tolerated.
• In June 2025, Sagimet Biosciences initiated a Phase 1 first-in-human clinical trial of TVB-3567, a second FASN inhibitor, for acne.
• In March 2025, Dermata Therapeutics announced that its Phase 3 STAR-1 trial of XYNGARITM, a once-weekly topical candidate, met all primary endpoints for moderate-to-severe acne. The 12-week trial showed statistically significant improvements vs placebo.

Request a sample and discover the recent breakthroughs happening in the moderate to severe inflammatory acne vulgaris pipeline landscape at https://www.delveinsight.com/report-store/moderate-to-severe-inflammatory-acne-vulgaris-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Moderate to Severe Inflammatory Acne Vulgaris Overview
Moderate to severe inflammatory acne vulgaris is a common chronic skin condition characterized by the presence of numerous inflamed lesions such as papules, pustules, nodules, and cysts. It typically affects the face, chest, and back, and is driven by a combination of excess sebum production, follicular hyperkeratinization, bacterial overgrowth (particularly Cutibacterium acnes), and inflammation. This form of acne can cause significant physical discomfort, including pain and tenderness, and often leads to long-term skin damage such as scarring and hyperpigmentation. Beyond its physical effects, it may also impact mental health, contributing to low self-esteem, anxiety, and depression. Early and effective treatment is essential to manage symptoms, reduce complications, and improve overall quality of life.

Find out more about moderate to severe inflammatory acne vulgaris medication at https://www.delveinsight.com/report-store/moderate-to-severe-inflammatory-acne-vulgaris-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Moderate to Severe Inflammatory Acne Vulgaris Treatment Analysis: Drug Profile
TVB-2640 - Sagimet Biosciences
TVB-2640 is a first-in-class oral inhibitor of fatty acid synthase (FASN), currently undergoing Phase II clinical trials for the treatment of moderate to severe acne vulgaris.

BOS 356 - Boston Pharmaceuticals
BOS 356, formerly known as GSK 3008356, is a selective diacylglycerol acyltransferase 1 (DGAT1) inhibitor being developed by Boston Pharmaceuticals. It is currently in Phase I clinical trials for moderate to severe acne vulgaris.

Learn more about the novel and emerging moderate to severe inflammatory acne vulgaris pipeline therapies at https://www.delveinsight.com/report-store/moderate-to-severe-inflammatory-acne-vulgaris-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Moderate to Severe Inflammatory Acne Vulgaris Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the Moderate to Severe Inflammatory Acne Vulgaris Pipeline Report
• Coverage: Global
• Key Moderate to Severe Inflammatory Acne Vulgaris Companies: Sagimet Biosciences, Boston Pharmaceuticals, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Botanix Pharmaceuticals, Cutia Therapeutics, Janssen Research & Development, LLC, Biofrontera Bioscience GmbH, Braintree Laboratories, and others.
• Key Moderate to Severe Inflammatory Acne Vulgaris Pipeline Therapies: TVB-2640, BOS 356, BTX 1503, FMX101, RA-18C3, ALA-PDT, BLI1100, and others.

To dive deep into rich insights for drugs used for moderate to severe inflammatory acne vulgaris treatment, visit: https://www.delveinsight.com/report-store/moderate-to-severe-inflammatory-acne-vulgaris-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Moderate to Severe Inflammatory Acne Vulgaris Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Moderate to Severe Inflammatory Acne Vulgaris Pipeline Therapeutics
6. Moderate to Severe Inflammatory Acne Vulgaris Pipeline: Late-Stage Products (Phase III)
7. Moderate to Severe Inflammatory Acne Vulgaris Pipeline: Mid-Stage Products (Phase II)
8. Moderate to Severe Inflammatory Acne Vulgaris Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform, PharmDelve.

This release was published on openPR.