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Add-back therapy
Add-back therapy restores hormonal levels that were suppressed by prior treatment, typically used to mitigate side effects of GnRH agonists in endometriosis or uterine fibroids.
Add-back therapy restores hormonal levels that were suppressed by prior treatment, typically used to mitigate side effects of GnRH agonists in endometriosis or uterine fibroids. Used for Endometriosis (as add-back to GnRH agonist therapy), Uterine fibroids (as add-back to GnRH agonist therapy).
At a glance
| Generic name | Add-back therapy |
|---|---|
| Sponsor | Bio Genuine (Shanghai) Biotech Co., Ltd. |
| Drug class | Hormone replacement therapy / Adjunctive hormonal therapy |
| Modality | Small molecule |
| Therapeutic area | Gynecology / Endometriosis / Uterine Fibroids |
| Phase | Phase 3 |
Mechanism of action
Add-back therapy involves the concurrent administration of low-dose estrogen and/or progestin alongside GnRH agonist treatment. This approach maintains the therapeutic benefits of GnRH agonists (which suppress ovarian hormone production) while reducing hypoestrogenic side effects such as hot flashes, vaginal dryness, and bone loss. The strategy allows for extended GnRH agonist use with improved tolerability.
Approved indications
- Endometriosis (as add-back to GnRH agonist therapy)
- Uterine fibroids (as add-back to GnRH agonist therapy)
Common side effects
- Breakthrough bleeding
- Headache
- Breast tenderness
- Nausea
Key clinical trials
- Effect of Kinesio Taping Application in Addition to Pilates Exercises on Core Muscle Thickness, Cognition and Mental Fatigue in Individuals With Non-specific Low Back Pain (NA)
- IASTM and Vibration Effects on Pain, Functionality, and Kinesiophobia in Lumbar Disc Herniation (NA)
- Exercise and Mindfulness in Patients With Non-specific Chronic Low Back Pain: The BACKFIT Project (NA)
- Testing the Addition of an Immunotherapy Agent, Atezolizumab, When Given With the Usual Chemo-Immunotherapy Drug Combination (Rituximab Plus Gemcitabine and Oxaliplatin) for Relapsed/Refractory (That Has Come Back or Not Responded to Treatment) Transformed Diffuse Large B-Cell Lymphoma (PHASE1)
- The Effect of Core Stabilization Exercises Applied With Virtual Reality-Based Telerehabilitation in the Treatment of Chronic Low Back Pain (NA)
- Testing the Addition of Iberdomide to Therapy in People With Neuroblastoma That Has Come Back, Not Responded to Treatment, or Gotten Worse (PHASE1, PHASE2)
- IASTM Effects on Pain, Functionality, and Proprioception in Subacromial Impingement (NA)
- Bone Stimulator for Spondylolysis (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Add-back therapy CI brief — competitive landscape report
- Add-back therapy updates RSS · CI watch RSS
- Bio Genuine (Shanghai) Biotech Co., Ltd. portfolio CI