Degenerative Disc Disease Pipeline 2025: Latest FDA Approvals, Clinical Trials, and Emerging Therapies Assessment by DelveInsight | Mesoblast, DiscGenics, Biosplice Therapeutics, BIOPHARM GmbH, Yuhan

Degenerative Disc Disease Pipeline 2025: Latest FDA Approvals, Clinical Trials, and Emerging Therapies Assessment by DelveInsight | Mesoblast, DiscGenics, Biosplice Therapeutics, BIOPHARM GmbH, Yuhan
(Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Degenerative Disc Disease pipeline constitutes 15+ key companies continuously working towards developing 15+ Degenerative Disc Disease treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

 

The Degenerative Disc Disease Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

“Degenerative Disc Disease Pipeline Insight, 2025″ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Degenerative Disc Disease Market.

 

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Some of the key takeaways from the Degenerative Disc Disease Pipeline Report:

  • Companies across the globe are diligently working toward developing novel Degenerative Disc Disease treatment therapies with a considerable amount of success over the years.

  • Degenerative Disc Disease companies working in the treatment market are Spine BioPharma, Inc., BioRestorative Therapies, Mesoblast, Ltd., Biosplice Therapeutics, Causeway Therapeutics, AnGes, Inc., DiscGenics, Kuros Biosciences, BioRestorative Therapies, Angitia Biopharmaceuticals, and others, are developing therapies for the Degenerative Disc Disease treatment

  • Emerging Degenerative Disc Disease therapies in the different phases of clinical trials are- SB-01, BRTX-100, Rexlemestrocel-L, Lorecivivint, CWT 002, AMG0103, IDCT, KUR 113, BRTX-100, AGA111, and others are expected to have a significant impact on the Degenerative Disc Disease market in the coming years.

  • In January 2026, ReGelTec Inc., a company advancing a percutaneous hydrogel implant for chronic low back pain associated with degenerative disc disease, announced the publication of a study in Pain Physician. The article reports that its HYDRAFIL System for disc augmentation demonstrated sustained, clinically meaningful reductions in pain and disability scores among patients suffering from degenerative disc disease–related chronic low back pain. The HYDRAFIL System is performed as an outpatient procedure and provides interventional pain specialists and patients with a minimally invasive treatment option aimed at relieving pain and enhancing daily functioning without requiring major surgery.

  • In December 2025, Companion Spine, a French-American company specializing in surgeon-driven spinal implant innovations, announced that the U.S. Food and Drug Administration (FDA) has granted approval for its DIAM™ Spinal Stabilization System (P240043). The DIAM™ device becomes the first posterior motion-preserving technology approved in the United States for treating moderate to severe primary low back pain caused by degenerative disc disease (DDD) at a single lumbar level (L2–L5). It is indicated for patients who continue to experience symptoms despite undergoing at least six months of conservative, non-surgical treatment.

  • In May 2025, ReGelTec Inc., a medical technology company focused on developing a percutaneous hydrogel implant to treat chronic low back pain resulting from degenerative disc disease, has announced that it has obtained CE Mark approval under the European Union Medical Device Regulation (MDR) for its Class III HYDRAFIL System for disc augmentation. This certification establishes a commercial pathway across Europe for the HYDRAFIL System—an outpatient treatment option that provides interventional pain specialists and patients with a minimally invasive alternative aimed at alleviating pain, enhancing daily function, and potentially avoiding the need for major surgical procedures.

  • In April 2025, DiscGenics, Inc., a privately owned, late-stage clinical biopharmaceutical company focused on developing allogeneic, cell-based regenerative therapies for musculoskeletal conditions, announced that its double-blind, peer-reviewed study titled “Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial,” has been recognized as one of the top three most impactful articles published in the International Journal of Spine Surgery (IJSS) in 2024.

  • In March 2025, Discure Technologies, a clinical-stage medical device company focused on innovative solutions for degenerative disc disease and other orthopedic conditions, announced its acceptance into the U.S. Food and Drug Administration’s (FDA) Total Product Life Cycle (TPLC) Advisory Program (TAP). This inclusion is expected to accelerate patient access to the company’s bioelectronic implant, the Discure System, which was previously granted Breakthrough Device designation by the FDA.

  • In September 2024, Spine BioPharma Inc. a company developing non‑opioid, non‑surgical therapies for degenerative disc disease has finished enrolling patients in its U.S. Phase 3 trial of SB‑01 for Injection. The MODEL study (MOderate–Severe Degenerative Disc Disease Evaluation of the Lumbar Spine) recruited 417 participants over two years at 30 research centers nationwide. SB‑01 is the first intradiscal drug therapy to advance to Phase 3 testing for chronic low‑back pain and associated functional loss caused by degenerative disc disease.

 

Degenerative Disc Disease Overview

Degenerative Disc Disease (DDD) is a condition where the intervertebral discs cushion-like structures between the spine’s vertebrae gradually lose hydration, flexibility, and height due to aging or wear and tear. This degeneration can lead to pain, stiffness, reduced mobility, and sometimes nerve compression, causing symptoms like numbness or weakness in the limbs. DDD most commonly affects the cervical (neck) and lumbar (lower back) spine. It is not technically a disease but a natural part of aging for many people. Treatment options include physical therapy, pain management, lifestyle changes, and in severe cases, surgical intervention like spinal fusion or disc replacement.

 

Explore the latest Degenerative Disc Disease pipeline insights 2025, including emerging therapies, clinical trials, and market opportunities. Stay ahead in Degenerative Disc Disease Clinical Trials

 

Emerging Degenerative Disc Disease Drugs Under Different Phases of Clinical Development Include:

  • SB-01: Spine BioPharma, Inc.

  • BRTX-100: BioRestorative Therapies

  • Rexlemestrocel-L: Mesoblast, Ltd.

  • Lorecivivint: Biosplice Therapeutics

  • CWT 002: Causeway Therapeutics

  • AMG0103: AnGes, Inc.

  • IDCT: DiscGenics

  • KUR 113: Kuros Biosciences

  • BRTX-100: BioRestorative Therapies

  • AGA111: Angitia Biopharmaceuticals

 

Degenerative Disc Disease Route of Administration

Degenerative Disc Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

  • Oral

  • Parenteral

  • Intravenous

  • Subcutaneous

  • Topical

 

Degenerative Disc Disease Molecule Type

Degenerative Disc Disease Products have been categorized under various Molecule types, such as

  • Monoclonal Antibody

  • Peptides

  • Polymer

  • Small molecule

  • Gene therapy

 

Degenerative Disc Disease Pipeline Therapeutics Assessment

  • Degenerative Disc Disease Assessment by Product Type

  • Degenerative Disc Disease By Stage and Product Type

  • Degenerative Disc Disease Assessment by Route of Administration

  • Degenerative Disc Disease By Stage and Route of Administration

  • Degenerative Disc Disease Assessment by Molecule Type

  • Degenerative Disc Disease by Stage and Molecule Type

 

DelveInsight’s Degenerative Disc Disease Report covers around 15+ products under different phases of clinical development like

  • Late-stage products (Phase III)

  • Mid-stage products (Phase II)

  • Early-stage product (Phase I)

  • Pre-clinical and Discovery stage candidates

  • Discontinued & Inactive candidates

  • Route of Administration

 

Further Degenerative Disc Disease product details are provided in the report. Download the Degenerative Disc Disease pipeline report to learn more about the emerging Degenerative Disc Disease therapies

 

Some of the key companies in the Degenerative Disc Disease Therapeutics Market include:

Key companies developing therapies for Degenerative Disc Disease are – Mesoblast, Ltd., BioRestorative Therapies, DiscGenics, Inc., Biosplice Therapeutics, Boehringer Ingelheim, SpineOvations, BIOPHARM GmbH, Yuhan, Histogen Inc., Spine BioPharma, Inc., Angitia Biopharmaceuticals, Notogen, AnGes, Inc., FibroGenesis, Genequine Biotherapeutics, Causeway Therapeutics, and others.

 

Degenerative Disc Disease Pipeline Analysis:

The Degenerative Disc Disease pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Degenerative Disc Disease with aggregate therapies developed by each company for the same.

  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Degenerative Disc Disease Treatment.

  • Degenerative Disc Disease key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

  • Degenerative Disc Disease Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Degenerative Disc Disease market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

 

Download Sample PDF Report to know more about Degenerative Disc Disease drugs and therapies

 

Degenerative Disc Disease Pipeline Market Drivers

  • Increase in the prevalence of Degenerative Disc Disease, increasing Research and Development activities are some of the important factors that are fueling the Degenerative Disc Disease Market.

 

Degenerative Disc Disease Pipeline Market Barriers

  • However, cost associated with the treatment, poor patient compliance and other factors are creating obstacles in the Degenerative Disc Disease Market growth.

 

Scope of Degenerative Disc Disease Pipeline Drug Insight

  • Coverage: Global

  • Key Degenerative Disc Disease Companies: Spine BioPharma, Inc., BioRestorative Therapies, Mesoblast, Ltd., Biosplice Therapeutics, Causeway Therapeutics, AnGes, Inc., DiscGenics, Kuros Biosciences, BioRestorative Therapies, Angitia Biopharmaceuticals, and others

  • Key Degenerative Disc Disease Therapies: SB-01, BRTX-100, Rexlemestrocel-L, Lorecivivint, CWT 002, AMG0103, IDCT, KUR 113, BRTX-100, AGA111, and others

  • Degenerative Disc Disease Therapeutic Assessment: Degenerative Disc Disease current marketed and Degenerative Disc Disease emerging therapies

  • Degenerative Disc Disease Market Dynamics: Degenerative Disc Disease market drivers and Degenerative Disc Disease market barriers

 

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Table of Contents

1. Degenerative Disc Disease Report Introduction

2. Degenerative Disc Disease Executive Summary

3. Degenerative Disc Disease Overview

4. Degenerative Disc Disease- Analytical Perspective In-depth Commercial Assessment

5. Degenerative Disc Disease Pipeline Therapeutics

6. Degenerative Disc Disease Late Stage Products (Phase II/III)

7. Degenerative Disc Disease Mid Stage Products (Phase II)

8. Degenerative Disc Disease Early Stage Products (Phase I)

9. Degenerative Disc Disease Preclinical Stage Products

10. Degenerative Disc Disease Therapeutics Assessment

11. Degenerative Disc Disease Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Degenerative Disc Disease Key Companies

14. Degenerative Disc Disease Key Products

15. Degenerative Disc Disease Unmet Needs

16 . Degenerative Disc Disease Market Drivers and Barriers

17. Degenerative Disc Disease Future Perspectives and Conclusion

18. Degenerative Disc Disease Analyst Views

19. Appendix

20. About DelveInsight

 

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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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