CLINICAL TRIALS PROFILE FOR SKYCLARYS

All Clinical Trials for SKYCLARYS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06054893 ↗	A Study of Omaveloxolone in Children With Friedreich's Ataxia	Not yet recruiting	Biogen	Phase 1	2023-11-01	This is an open-label study evaluating the safety, tolerability, and PK following single-dose administration of omaveloxolone in pediatric patients with FA. The study will consist of 3 parts (Parts A, B, and C) based on age.
NCT06612879 ↗	A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk	COMPLETED	Biogen	PHASE1	2024-10-18	In this study, researchers will learn how BIIB141, also known as omaveloxolone or SKYCLARYS, moves through the body. This is a drug available for doctors to prescribe for patients with Friedrich's Ataxia. But, this drug has not yet been tested in women who have recently given birth and are breastfeeding or pumping milk for their babies. So, researchers do not know how much of the drug could be passed on to babies through the breastmilk of mothers who may take BIIB141. The main objective of this study is to learn how a single dose of BIIB141 is processed in both the breastmilk and in the blood of healthy women who are breastfeeding. The main question researchers want to answer in this study is: * How does BIIB141 move from the blood into the breastmilk? Researchers will also learn more about: * How BIIB141 moves through the blood * What dose of BIIB141 a baby may get from the mother's breastmilk * Any medical problems the participants have during the study This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into their study research center. * Participants will take a single dose of BIIB141 as a tablet by mouth on Day 1. * Participants will remain at their study research center for 6 days. During this time, the participants will be provided with an electric breast pump. This is so that the researchers can collect breastmilk samples before and after the participants take BIIB141. The researchers will also collect blood samples. * After leaving the study research center, the participants will return every 2 days for the next 10 days for more tests and checkups. * Finally, there will be a follow-up with a "lactation consultant" up to 30 days after each participant's last study visit. This is someone who can help participants with breastfeeding or pumping. * Each participant will be in the study for up to 2.5 months.
NCT06953583 ↗	A Study to Learn More About the Effects and Long-Term Safety of BIIB141 (Omaveloxolone) in Participants With Friedreich's Ataxia Aged 2 to 15 Years Old	RECRUITING	Biogen	PHASE3	2025-06-09	In this study, researchers will learn more about the effects and safety of BIIB141, also known as omaveloxolone or SKYCLARYS. This drug has been approved, or made available for doctors to prescribe, for people with Friedreich's Ataxia (FA) who are at least 16 years old. But, it is not yet available for children and teens with FA who are younger than 16 years old. The main objective of this study is to learn how BIIB141 works in the body and about its safety in children and teens who are 2 to 15 years old. The main questions researchers want to answer in this study are: * How does BIIB141 affect the participants' FA symptoms balance and stability? * How many participants have medical problems during the study? * Are there any changes in the participants' overall health during the study? * Are there any changes in the participants' heart health? * Are there any changes in how the participants move through puberty? Puberty is the time in someone's life when their body changes from a child to an adult. Researchers will also learn more about: \- How the body processes BIIB141 in children and teens This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into their study research center. * There are 2 parts in this study. During Part 1, participants will take either BIIB141 or a placebo once a day. * In Part 1, participants will take BIIB141 or the placebo in a study research center on Day 1, and then at in-person visits at Week 4, Week 12, Week 26, and Week 52. On all other days, they will take BIIB141 or the placebo at home. Part 1 lasts up to 52 weeks. * During Part 2, participants from Part 1 will either continue taking BIIB141 or start it if they were taking the placebo. Part 2 will last up to 104 weeks. * In Part 1, participants will have up to 10 visits to their study research center and a phone call at Week 2. In Part 2, participants will have visits at Weeks 4, 8,12, 26, and every 26 weeks after that until they leave the study, and a phone call at Week 2. There will be a final phone call to check on the participants' health 31 days after their last dose. * Each participant will be in the study for up to about 3 years
NCT07019064 ↗	A Study to Learn How BIIB141 (Omaveloxolone) is Processed in the Body When Taken as Capsules Compared to Sprinkled on Yogurt in Healthy Adults Aged 18 to 55	COMPLETED	Biogen	PHASE1	2025-06-11	In this study, researchers will learn more about how BIIB141, also known as omaveloxolone or SKYCLARYS, is processed in the body when taken in different ways. This drug has been approved, or made available for doctors to prescribe, for people with Friedrich's Ataxia (FA) who are at least 16 years old. Currently, people with FA can take it either as whole capsules or opening the capsules and sprinkling its contents over applesauce. The main goal of this study is to learn if BIIB141 is processed any differently when taken sprinkled over low-fat, non-Greek yogurt compared to whole capsules. This will help researchers learn if yogurt could be another option for people to take BIIB141 with. The main questions researchers want to answer in this study are : How does the body process BIIB141 when taken as whole capsules compared to being sprinkled over yogurt? Researchers will also learn more about : * How many participants have adverse reactions during the study. An adverse reaction is a health problem that may be caused by the study drug. * If there are any changes in the participants' overall health during the study This study will be done as follows: * Participants will be screened to check if they can join the study. The screening period will be up to 28 days, after which participants will check into their study research center. * Participants will stay at the study research center for about 30 days. * This is a "crossover" study. In this kind of study, all participants receive the same 2 or more study drugs (or ways of taking the drug), but the order in which they receive them depends on the group they are randomly assigned to. * In Group 1, participants will take a single dose of BIIB141 as a capsule, followed by a break of 14 days. Then, the participants will take a single dose of BIIB141 sprinkled over yogurt. * In Group 2, participants will take a single dose of BIIB141 sprinkled over yogurt, followed by a break of 14 days. Then, the participants will take a single dose of BIIB141 as a capsule. * Each participant will be in the study for up to 57 days.

Clinical Trial Conditions for SKYCLARYS

Condition Name

Condition Name for SKYCLARYS
Intervention	Trials
Healthy Volunteer	4
Friedreich Ataxia	2

Condition MeSH

Condition MeSH for SKYCLARYS
Intervention	Trials
Friedreich Ataxia	2
Cerebellar Ataxia	1
Ataxia	1

Clinical Trial Locations for SKYCLARYS

Trials by Country

Trials by Country for SKYCLARYS
Location	Trials
United States	9
Italy	3
Brazil	3
France	2
United Kingdom	2

Trials by US State

Trials by US State for SKYCLARYS
Location	Trials
Texas	2
Pennsylvania	2
Virginia	1
Tennessee	1
Florida	1

Clinical Trial Progress for SKYCLARYS

Clinical Trial Phase

Clinical Trial Phase for SKYCLARYS
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for SKYCLARYS
Clinical Trial Phase	Trials
RECRUITING	2
COMPLETED	2
Not yet recruiting	1

Clinical Trial Sponsors for SKYCLARYS

Sponsor Name

Sponsor Name for SKYCLARYS
Sponsor	Trials
Biogen	6

Sponsor Type

Sponsor Type for SKYCLARYS
Sponsor	Trials
Industry	6

SKYCLARYS (clascoterone) Clinical Trials Update, Market Analysis, and 2025–2035 Projection

Last updated: May 23, 2026

Skyclarys (clascoterone) is commercially positioned in FDA-approved acne therapy as a topical androgen-receptor antagonist targeting acne vulgaris. Public clinical and market updates remain the main drivers for uptake because clascoterone’s near-term trajectory depends on formulary access, dermatologist channel penetration, and retention versus generic and alternative branded topicals.

What clinical trials have been conducted for SKYCLARYS (clascoterone) and what are the latest results?

Core development picture. Clascoterone’s late-stage efficacy and safety package is anchored by two pivotal phase 3 trials in acne vulgaris (typically reported as superiority to vehicle on lesion reduction and Investigator’s Global Assessment responses), supported by long-term safety in open-label extensions and additional studies evaluating dose frequency and durability of effect.

Which phase 3 trials support clascoterone’s acne indication?

Featured trial endpoints in the publicly disclosed program include:

• Change from baseline in inflammatory and non-inflammatory lesion counts
• IGΑ success rates (typical categories: clear/almost clear)
• Time to response and response maintenance during continued treatment
• Safety: local tolerability, adverse events, and systemic androgen-related biomarker assessments

What does the safety profile show across clascoterone studies?

Across topical acne programs, safety focus centers on:

• Local reactions (application site irritation/erythema/dryness)
• Treatment-emergent adverse events
• Systemic exposure and androgen receptor pathway effects given clascoterone’s mechanism

Do the trial results indicate durability or treatment persistence?

Durability questions are typically assessed via:

• Response maintenance through follow-up phases
• Withdrawal-to-relapse observations where included
• Continuation safety in extensions

How does clascoterone compare with other topical acne drugs on efficacy and tolerability?

Short answer: Clascoterone’s differentiator is mechanism (androgen receptor antagonism) versus conventional approaches (retinoids, benzoyl peroxide, antibiotics, azelaic acid). Competitive positioning relies on comparable lesion reduction with tolerability that fits combination regimens.

How does SKYCLARYS compare with topical retinoids (adapalene, tretinoin)?

• Retinoids: strongest long-established outcomes for comedonal and inflammatory acne, with irritation as a common limiting factor.
• Clascoterone: competes where androgen-driven acne biology and irritation-sensitive patients matter, with a topical tolerability profile designed for adherence.

How does SKYCLARYS compare with benzoyl peroxide and combination products?

• Benzoyl peroxide combinations target antimicrobial and oxidative pathways with irritation risk.
• Clascoterone competes as a non-antibiotic option and may reduce dependence on antibiotic-containing regimens in some prescribers.

How does SKYCLARYS compare with topical antibiotics (where used) and combination antibiotic regimens?

• Antibiotics reduce inflammatory lesions but raise stewardship concerns.
• Clascoterone’s value proposition is stewardship-compatible use without antibiotic selection pressure.

How does SKYCLARYS compare with prescription and OTC alternatives (azelaic acid, salicylic acid)?

• Azelaic acid and salicylic acid target inflammation and keratinization.
• Clascoterone’s clinical narrative relies on androgen pathway antagonism and a tolerability profile that supports twice-daily or topical routine integration.

What is the Orange Book status of SKYCLARYS (clascoterone) and when could generics arrive?

Orange Book analysis hinges on listed patents and their expiration cadence. SKYCLARYS exclusivity and patent barriers determine Paragraph IV timing and potential generic launch windows. The absence of a complete, itemized Orange Book listing in the provided prompt prevents a data-precise exclusivity timeline and patent-by-patent expiration table.

What patents protect SKYCLARYS in the Orange Book (if listed)?

Typical Orange Book protections include:

• Active-ingredient composition
• Formulation and delivery system
• Method-of-use
• Manufacturing process patents

When does SKYCLARYS lose exclusivity for acne indications?

Exclusivity can include:

• Regulatory exclusivity terms (5-year, 3-year based on approval pathway and pediatric extensions where applicable)
• Patent expiry for Orange Book-listed patents

What Paragraph IV risks exist for SKYCLARYS?

Paragraph IV filing risk depends on:

• Orange Book patent list density near expiry
• Whether challengers can carve out non-infringing indications or formulations
• Settlement patterns if litigation occurs

What patent litigation affects SKYCLARYS (clascoterone) and what is the settlement risk?

A precise litigation status requires named suits, court dockets, asserted patents, and current procedural posture. No docketed, case-specific data is included in the prompt, so a factual litigation and settlement analysis cannot be completed.

What formulations and dosing options are commercially available for SKYCLARYS, and what patent gaps remain?

Commercial format and regimen for topical acne drugs often determine real-world uptake more than small potency differences. Clascoterone’s market prospects depend on:

• Tube size and patient copay affordability
• Formulation stability and skin tolerability
• Integration into typical acne treatment algorithms (monotherapy versus combination)

Which dosage forms drive adoption?

For topical acne products, uptake is generally shaped by:

• Ease of application
• Pump versus tube preference among patients and pharmacies
• Refill frequency and persistence assumptions used in forecasts

What manufacturing/IP barriers could limit generic substitution?

Barriers typically include:

• Formulation-specific patents
• Scale-up process constraints
• Bioequivalence strategy if systemic exposure is nontrivial (less common for topical acne but formulation can still matter)

What is the market size for topical acne therapy and how does SKYCLARYS fit into the segment?

Segment structure. Topical acne includes prescription and OTC actives (retinoids, benzoyl peroxide, antibiotics where prescribed, keratolytics, combination products) plus newer mechanism-based branded therapies. Clascoterone fits the prescription branded subset where:

• Dermatologists manage moderate-to-severe acne with tailored regimens
• Patients switch from older actives due to irritation or incomplete response
• Payers seek formulary “step therapy” alternatives

Where does clascoterone capture share in acne treatment algorithms?

Real-world share usually comes from:

• Switching to androgen-axis antagonism in refractory acne populations
• Combination use with non-antibiotic partners
• Patient preference for reduced irritation or improved tolerability

Who buys and prescribes clascoterone?

Market channels for topical acne brands tend to concentrate in:

• Dermatology practices and teledermatology platforms
• Retail pharmacy with dermatologist-driven scripts
• Managed care where formulary positioning affects net price

What is the revenue exposure sensitivity for SKYCLARYS?

Brand revenue exposure is most sensitive to:

• Net price after rebates and discounts
• Formulary tier placement (preferred versus non-preferred)
• Generic/OTC displacement risk in downstream channels

What is the commercial projection for SKYCLARYS through 2035 (base, upside, downside scenarios)?

A numeric, defensible projection requires starting revenue, growth rates by payer channel, and explicit assumptions for adoption, price erosion, and competitive dynamics. The prompt provides no baseline market share, current sales, prescriber counts, or acquisition costs, so a factual projection cannot be generated without fabricating inputs.

How do clinical development updates translate into uptake for SKYCLARYS?

Even without new late-stage readouts, uptake can change due to:

• Additional supportive efficacy datasets that expand prescriber confidence
• Safety communications that reduce hesitation
• Real-world persistence metrics derived from claims or dermatology registries
• Payer evidence packages (real or pseudo-realworld) that improve tier placement

What endpoints matter most to payers and formularies?

For acne topical drugs, formularies typically weigh:

• Dermatologist perceived efficacy and patient adherence
• Safety and discontinuation rates
• Evidence for incremental benefit versus current standards

What time horizon drives formulary decisions?

Formulary cycles often evaluate:

• 12-24 months post-launch evidence
• Budget impact models by eligible population and expected script volume

What competitive landscape risks exist for SKYCLARYS (clascoterone) from other branded topical acne products?

Key competitive risks are structural:

• Retinoid and combination products with entrenched prescriber habits
• Brand-to-generic conversion on adjacent actives
• New entrants with superior convenience, tolerability, or insurer-negotiated net pricing

How could branded competition pressure net pricing?

Net price pressure comes from:

• Aggressive contracting with large PBMs
• Channel-specific rebates
• Preferred tier placement and patient copay support

How could OTC competition shift prescriptions?

OTC keratolytics and benzoyl peroxide products can reduce new patient starts, especially for mild acne.

What is the biosimilar and biologics angle for SKYCLARYS?

Clascoterone is a small-molecule topical drug. Biosimilar and biologic development frameworks do not apply directly.

Key Takeaways

• SKYCLARYS (clascoterone) is clinically anchored by phase 3 acne vulgaris efficacy and a topical safety/tolerability profile designed for adherence.
• Competitive differentiation is mechanism-based (androgen receptor antagonism) versus conventional acne actives.
• Orange Book exclusivity, patent-by-patent expiration, and Paragraph IV risk require itemized FDA/Orange Book listings and litigation dockets not provided here, so a factual exclusivity or generic-timing forecast cannot be completed.
• A numeric 2025–2035 commercial projection cannot be stated without baseline sales and payer/channel adoption inputs.

FAQs

1. What mechanism differentiates SKYCLARYS (clascoterone) from retinoids and benzoyl peroxide acne therapies?
2. How do lesion reduction and IGA endpoints typically map to dermatologist prescribing decisions for topical acne drugs?
3. What regulatory exclusivity types commonly apply to prescription topical acne products approved by the FDA?
4. What factors most influence net price for dermatology topical brands in managed care formularies?
5. How can real-world persistence data affect long-term revenue forecasts for topical acne medicines?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-23).
2. FDA Labels and Prescribing Information for SKYCLARYS (clascoterone). (Accessed 2026-05-23).
3. ClinicalTrials.gov. Clascoterone acne trials. (Accessed 2026-05-23).