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Almirall SA (GB:0O9B)
LSE:0O9B
Lebrikizumab
Eczema, Dermatitis, Atopic
Phase III
Recruiting
A Study of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
Jul 24, 2024
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Lad191
Healthy Volunteers, Autoimmune Disease
Phase I
Recruiting
Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease
Jun 28, 2024
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Lad603
Healthy Volunteers
Phase I
Recruiting
A Single and Multiple Ascending Dose Study of LAD603 in Healthy Subjects
Dec 22, 2023
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Vehicle Ointment, Tirbanibulin
Keratosis, Actinic
Phase III
Completed
A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis
Nov 13, 2023
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Lebrikizumab
Atopic Dermatitis, Eczema
Phase III
Active Not Recruiting
Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
Aug 07, 2023
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Lebrikizumab
Atopic Dermatitis
Phase III
Active Not Recruiting
Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis
May 30, 2023
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Tirbanibulin 2.5 Mg Ointment
Actinic Keratosis
Phase IV
Completed
A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses
Feb 14, 2023
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Tirbanibulin (Klisyri®) 10 Mg/G Ointment, Diclofenac Sodium 3% Gel
Keratosis, Actinic
Phase IV
Active Not Recruiting
A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp
May 19, 2022
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Tirbanibulin Ointment 1%
Keratosis, Actinic
Phase III
Completed
A Study to Evaluate the Safety and Tolerability of Tirbanibulin Ointment 1% in Adult Participants With Actinic Keratosis
Mar 01, 2022
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Lebrikizumab
Eczema, Dermatitis, Atopic
Phase III
Completed
A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for Cyclosporine
Nov 26, 2021
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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 Almirall SA (0O9B) have in its pipeline
0O9B is currently developing the following drugs: Lebrikizumab, Lad191, Lad603. These drug candidates are in various stages of clinical development as the company works toward FDA approval.