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mastalgia-oil
mastalgia-oil is a Small molecule drug developed by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. It is currently in Phase 3 development for Breast pain (mastalgia).
Mastalgia-oil is used to alleviate breast pain, though its exact mechanism of action is not fully understood.
Mastalgia-oil is used to alleviate breast pain, though its exact mechanism of action is not fully understood. Used for Breast pain (mastalgia).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | mastalgia-oil |
|---|---|
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | Phase 3 |
Mechanism of action
It is believed that Mastalgia-oil may work through topical application, providing relief by affecting local nerve endings or reducing inflammation in the breast tissue.
Approved indications
- Breast pain (mastalgia)
Common side effects
- Skin irritation
Key clinical trials
- External Mastalgia-oil Versus Placebo in Premenopausal Women With Severe Mastalgia (PHASE3)
- External Mastalgia-oil Versus Oral Tamoxifen in Premenopausal Women with Severe Mastalgia (PHASE3)
- RCT of Evening Primrose Oil for the Treatment of Breastfeeding Pain (NA)
- Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer (PHASE4)
- Randomized Clinical Trial of Vitamin E and Evening Oil of Primrose for the Managment of Breast Pain (PHASE2, PHASE3)
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:
- mastalgia-oil CI brief — competitive landscape report
- mastalgia-oil updates RSS · CI watch RSS
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University portfolio CI
Frequently asked questions about mastalgia-oil
What is mastalgia-oil?
How does mastalgia-oil work?
What is mastalgia-oil used for?
Who makes mastalgia-oil?
What development phase is mastalgia-oil in?
What are the side effects of mastalgia-oil?
Related
- Manufacturer: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Breast pain (mastalgia)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing