Kb803
Recessive Dystrophic Epidermolysis Bullosa, Dystrophic Epidermolysis Bullosa, Deb - Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa
Phase III
Recruiting
A Study Assessing KB803 Compared to Matching Placebo for the Treatment and Prevention of Corneal Abrasions in Dystrophic Epidermolysis Bullosa
May 27, 2025
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Kb801
Neurotrophic Keratitis
Phase I/II
Recruiting
A Study Assessing KB801 for the Treatment of Stage 2 or 3 Neurotrophic Keratitis
May 14, 2025
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Kb304, 0.9% Normal Saline (Ns)
Wrinkles In Decolletage, Pigmentation, Décolleté Wrinkles
Phase I/II
Active Not Recruiting
A Study Assessing KB304 for the Treatment of Wrinkles in Women
Dec 05, 2024
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Docetaxel, Chemotherapy, Pembrolizumab (Keytruda®), Kb707
Advanced Cancer, Solid Tumor, Adult, Lung Cancer, Non-Small Cell, Lung Cancer Metastatic, Lung Cancer (Nsclc)
Phase I/II
Recruiting
A Study Assessing KB707 for the Treatment of Advanced Solid Tumor Malignancies Affecting the Lungs
Jan 18, 2024
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Kb408 (Nebulization)
Alpha 1-Antitrypsin Deficiency
Phase I
Recruiting
A Study of KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency
Sep 15, 2023
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Kb707, Opdualag, Keytruda ®( Pembrolizumab)
Cancer, Cutaneous Melanoma, Melanoma Stage Iii, Melanoma Stage Iv
Phase I/II
Recruiting
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
Jul 24, 2023
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Kb407 (Nebulization)
Cystic Fibrosis
Phase I
Recruiting
A Study Assessing KB407 for the Treatment of Cystic Fibrosis
Aug 15, 2022
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Kb301
Wrinkle, Skin Roughness, Fine Lines, Skin Thickness
Phase I
Active Not Recruiting
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
Aug 19, 2020
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Krystal Biotech (4KB) have in its pipeline
4KB is currently developing the following drugs: Kb803, Kb801, Kb304, 0.9% Normal Saline (Ns). These drug candidates are in various stages of clinical development as the company works toward FDA approval.