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GDC 268 Lotion
GDC 268 Lotion is a corticosteroid Small molecule drug developed by Balmoral Medical company. It is currently in Phase 3 development for Seborrheic dermatitis.
GDC 268 Lotion is a topical corticosteroid used to reduce inflammation and itching.
GDC 268 Lotion is a topical corticosteroid used to reduce inflammation and itching. Used for Seborrheic dermatitis.
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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 | GDC 268 Lotion |
|---|---|
| Sponsor | Balmoral Medical company |
| Drug class | corticosteroid |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | Phase 3 |
Mechanism of action
GDC 268 Lotion works by inhibiting the production of inflammatory mediators, thereby reducing the symptoms of inflammation and itching. This is achieved through the topical application of a corticosteroid, which is a class of medications that are effective in reducing inflammation and itching. The exact mechanism of action of GDC 268 Lotion is not fully understood, but it is believed to involve the inhibition of phospholipase A2, an enzyme involved in the production of inflammatory mediators.
Approved indications
- Seborrheic dermatitis
Common side effects
- Skin atrophy
- Hypersensitivity
Key clinical trials
- Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris (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:
- GDC 268 Lotion CI brief — competitive landscape report
- GDC 268 Lotion updates RSS · CI watch RSS
- Balmoral Medical company portfolio CI
Frequently asked questions about GDC 268 Lotion
What is GDC 268 Lotion?
How does GDC 268 Lotion work?
What is GDC 268 Lotion used for?
Who makes GDC 268 Lotion?
What drug class is GDC 268 Lotion in?
What development phase is GDC 268 Lotion in?
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Related
- Drug class: All corticosteroid drugs
- Manufacturer: Balmoral Medical company — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Seborrheic dermatitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing