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APP13007, 0.05%
APP13007, 0.05% is a Prostaglandin F receptor agonist Small molecule drug developed by Formosa Pharmaceuticals, Inc.. It is currently in Phase 3 development for Glaucoma, Ocular hypertension.
APP13007 is a topical ophthalmic agent designed to reduce intraocular pressure in glaucoma and ocular hypertension.
APP13007 is a topical ophthalmic agent designed to reduce intraocular pressure in glaucoma and ocular hypertension. Used for Glaucoma, Ocular hypertension.
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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 | APP13007, 0.05% |
|---|---|
| Sponsor | Formosa Pharmaceuticals, Inc. |
| Drug class | Prostaglandin F receptor agonist |
| Target | FP receptor (prostaglandin F receptor) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
APP13007 is a selective prostaglandin F (FP) receptor agonist formulated as a 0.05% ophthalmic solution. It works by increasing uveoscleral outflow of aqueous humor from the eye, thereby lowering intraocular pressure. This mechanism is typical of prostaglandin analogs used in glaucoma management.
Approved indications
- Glaucoma
- Ocular hypertension
Common side effects
- Conjunctival hyperemia
- Iris pigmentation changes
- Eyelash growth
- Eye irritation
Key clinical trials
- Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study (PHASE3)
- Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery (PHASE3)
- A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery (PHASE2)
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:
- APP13007, 0.05% CI brief — competitive landscape report
- APP13007, 0.05% updates RSS · CI watch RSS
- Formosa Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about APP13007, 0.05%
What is APP13007, 0.05%?
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What is APP13007, 0.05% used for?
Who makes APP13007, 0.05%?
What drug class is APP13007, 0.05% in?
What development phase is APP13007, 0.05% in?
What are the side effects of APP13007, 0.05%?
What does APP13007, 0.05% target?
Related
- Drug class: All Prostaglandin F receptor agonist drugs
- Target: All drugs targeting FP receptor (prostaglandin F receptor)
- Manufacturer: Formosa Pharmaceuticals, Inc. — full pipeline
- Therapeutic area: All drugs in Ophthalmology
- Indication: Drugs for Glaucoma
- Indication: Drugs for Ocular hypertension
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing