Quoin Pharmaceuticals has won FDA Fast Track Designation for QRX003, a topical lotion, to treat Peeling Skin Syndrome — the first Fast Track designation FDA has ever granted for the ultra-rare disease. The Ashburn, Virginia micro-cap announced the designation 22 September 2026, three months after filing what it says is the first company-sponsored IND the disease has ever had, and six months after QRX003 won a separate Fast Track designation for a different rare skin disease, Netherton Syndrome.
A reverse merger, then two rare diseases
From a 2018 startup to two Fast Tracks
- 2018
Quoin Inc. founded
Co-founded by Dr. Michael Myers to develop topical therapies for rare and orphan skin diseases.
- 29 October 2021
Begins trading on Nasdaq
Quoin Pharmaceuticals, Ltd. begins trading as QNRX following a corporate combination with the already-listed Cellect Biotechnology Ltd.
- 11 March 2026
First Fast Track: Netherton Syndrome
FDA grants QRX003 its first Fast Track designation, for the rare skin disorder Netherton Syndrome.
- 2 June 2026
First-ever Peeling Skin Syndrome IND filed
Quoin submits what it describes as the first IND application any company has filed with FDA for the disease.
- July 2026
IND cleared
FDA clears the Peeling Skin Syndrome IND, opening the path to a company-sponsored trial.
- 28 August 2026
Private placement, up to $50.0 million
Financing announced with participation from Sirenia Capital Management, Sphera Healthcare, AIGH Capital Management and Nantahala Capital, among others.
- 22 September 2026
Second Fast Track: Peeling Skin Syndrome
FDA grants Fast Track Designation — the first ever given for the disease.
- Second half of 2026
Phase 2/3 study planned
Company-sponsored study expected to enroll an estimated 6 to 12 pediatric and adult patients across the U.S. and Europe.
What Fast Track buys, and what it doesn't
Fast Track Designation gives Quoin more frequent, earlier access to FDA reviewers and, eventually, the option of a rolling submission — not an approval, and not a guarantee one follows. For a disease with no company-sponsored regulatory program before this one, the practical effect is that Quoin can now ask FDA questions as it designs a pivotal trial rather than guessing. According to the 22 September announcement, Quoin plans a company-sponsored Phase 2/3 study in the second half of 2026, dosing QRX003 twice daily to more than 80% of body surface area over a planned 48-week treatment period with an interim review at 24 weeks; the company has said it expects to enroll roughly 6 to 12 pediatric and adult patients across the United States and Europe, though earlier company statements cited a narrower range and no ClinicalTrials.gov registration exists yet.
The designation follows a single-subject case study rather than a company-run trial: an investigator-led pediatric patient treated with QRX003 for more than fifteen months, with reported improvements in skin appearance and itching, better quality-of-life measures, and no adverse events — the evidentiary basis for the IND FDA cleared in July. It is real duration on one patient, not yet the randomized data a Phase 2/3 study is designed to produce.
“This is an important regulatory milestone for QRX003 and for a community that today has no approved treatment. Quoin submitted the first IND ever filed with the FDA for Peeling Skin Syndrome, that IND was cleared in July, and QRX003 has now been granted Fast Track Designation for the disease.” Dr. Michael Myers, Chairman and CEO, Quoin Pharmaceuticals — 22 September 2026 announcement
QRX003 in four numbers
Figures from Quoin’s own announcements and NORD/NIH GARD disease summaries; Peeling Skin Syndrome’s true prevalence is likely undercounted due to misdiagnosis.
One lotion, two rare diseases
QRX003 is a broad-spectrum serine protease inhibitor formulated in Quoin’s proprietary Invisicare topical delivery system, applied whole-body twice a day. The company has not disclosed the specific active ingredient, treating the formulation as proprietary. What is public is the pattern: the same molecule, in the same delivery vehicle, is now Fast Track designated for two genetically distinct rare skin diseases six months apart — Netherton Syndrome, where two Phase 2/3 studies are already recruiting (NCT07538583 and NCT06953466), and Peeling Skin Syndrome, where Quoin is still designing its first trial.
Three things Quoin is betting on
First IND for PSS
Quoin filed the first-ever IND for Peeling Skin Syndrome in June 2026, and FDA cleared it the next month — the only company-sponsored regulatory program this disease has ever had.
Second Fast Track
QRX003 now carries Fast Track designations for two distinct rare skin diseases in the same year, giving Quoin two shots at expedited review from one molecule and one delivery platform.
No approved rival
Peeling Skin Syndrome has no FDA-approved therapy today; patients rely on supportive care — emollients and moisturizers — which is the standard QRX003 will ultimately have to beat.
A market too rare for either forecast to see
Peeling Skin Syndrome is rare enough that no market-research publisher covers it on its own; the closest published figures size the broader “rare dermatological disease” category, and even those disagree with each other by more than a billion dollars in the same base year. NORD and the NIH’s Genetic and Rare Diseases Information Center describe generalized Peeling Skin Syndrome as fewer than 100 reported cases in the medical literature, with the acral (hands-and-feet) form affecting fewer than 1,000 people in the United States — a population too small to register as a line item in either forecast below.
Rare dermatology, priced two ways
$5.74B → $10.5B
Global rare dermatological disease treatment market, as forecast by two publishers using different base years: Spherical Insights (2023–2033) and Wise Guy Reports (2025–2035).
Sources: Spherical Insights, Rare Dermatological Disease Treatment Market · Wise Guy Reports, Rare Dermatological Disease Treatment Market
Regulatory News outlook
Peeling Skin Syndrome itself is too rare to move either forecast, so we read this designation as a regulatory and platform bet rather than a revenue one: a second Fast Track for QRX003 that de-risks Quoin’s broader Invisicare franchise more than it adds to either market figure above.
How we got here: NORD and NIH GARD both describe generalized Peeling Skin Syndrome as fewer than 100 reported cases; against even the smaller $5.74 billion 2025 rare-dermatology forecast, a disease of that size is a rounding error, which is why we frame the milestone as validating the platform rather than sizing a market.
QRX003 against a disease with no rival product
| Program | Disease | Status | What patients use today |
|---|---|---|---|
| QRX003 (Peeling Skin Syndrome) | Peeling Skin Syndrome | Fast Track designated Sept 2026; IND cleared July 2026; Phase 2/3 planned 2H 2026 | Supportive care only — emollients and moisturizers; no FDA-approved therapy |
| QRX003 (Netherton Syndrome) | Netherton Syndrome | Fast Track designated March 2026; two Phase 2/3 studies recruiting | Emollients, topical corticosteroids, keratolytics |
| BCX17725 (BioCryst Pharmaceuticals) | Netherton Syndrome | Reported Fast Track designation for a different program, per third-party pipeline trackers | Same supportive-care baseline |
From Quoin’s own announcements and third-party pipeline trackers; Peeling Skin Syndrome has no other company-sponsored program on record, so this compares QRX003 across its two indications rather than against a competing product.
What a 6-to-12-patient trial has to show
Quoin is a small company by any measure: it reported $3.8 million in cash and $7.0 million in investments as of 30 June 2026 alongside going-concern language in its quarterly filing, then announced a private placement of up to $50.0 million on 28 August 2026 — a sequence that changes the funding picture materially but does not erase the risk a reader should weigh against a Fast Track headline. The company has not disclosed a specific dollar figure earmarked for the Peeling Skin Syndrome program.
- Trial design: a company-sponsored Phase 2/3 study planned for the second half of 2026, dosing QRX003 twice daily to more than 80% of body surface area over a 48-week treatment period with a 24-week interim review.
- Enrollment: an estimated 6 to 12 pediatric and adult patients across the U.S. and Europe — no ClinicalTrials.gov registration exists yet.
- Evidence to date: one investigator-led pediatric case, treated more than fifteen months, with reported improvement and no adverse events — not yet controlled trial data.
- Financing: a private placement of up to $50.0 million announced 28 August 2026, weeks before the going-concern language in Quoin’s most recent quarterly filing would otherwise have stood alone.
What is not yet public: a specific active ingredient for QRX003, a confirmed enrollment count for the Peeling Skin Syndrome study, and any trial registry entry for it. Regulatory News will update this page as those details are confirmed.
Sources & further reading
- Quoin Pharmaceuticals, “Quoin Pharmaceuticals Announces FDA Fast Track Designation for QRX003 for the Treatment of Peeling Skin Syndrome,” press release, 22 September 2026. globenewswire.com
- RTTNews, “Quoin Gets FDA Fast Track Designation For QRX003 In Peeling Skin Syndrome,” 22 September 2026. rttnews.com
- Quoin Pharmaceuticals, “Quoin Pharmaceuticals Announces FDA Grants Fast Track Designation for QRX003 for the Treatment of Netherton Syndrome,” press release, 11 March 2026. globenewswire.com
- Quoin Pharmaceuticals investor relations, “Quoin Pharmaceuticals Submits IND Application for QRX003 for Peeling Skin Syndrome.” investors.quoinpharma.com
- Quoin Pharmaceuticals investor relations, “Quoin Pharmaceuticals Receives FDA IND Clearance to Initiate Phase 2/3 Study.” investors.quoinpharma.com
- Quoin Pharmaceuticals, “Quoin Pharmaceuticals Announces Private Placement Financing of Up to $50.0 Million,” press release, 28 August 2026. globenewswire.com
- National Organization for Rare Disorders (NORD), “Peeling Skin Syndrome.” rarediseases.org
- NIH Genetic and Rare Diseases Information Center (GARD), “Peeling Skin Syndrome.” rarediseases.info.nih.gov
- Spherical Insights, “Rare Dermatological Disease Treatment Market.” sphericalinsights.com
- Wise Guy Reports, “Rare Dermatological Disease Treatment Market.” wiseguyreports.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did FDA grant Quoin Pharmaceuticals?
Fast Track Designation for QRX003, a topical serine protease inhibitor lotion, to treat Peeling Skin Syndrome — the first Fast Track designation FDA has ever granted for the disease. Quoin announced it 22 September 2026.
Is this QRX003's first Fast Track designation?
No. QRX003 already holds a separate Fast Track designation for a different rare skin disease, Netherton Syndrome, granted 11 March 2026. The September designation is its second this year.
Has FDA approved QRX003 for anything?
No. Fast Track status speeds up interaction with FDA and future review; it is not an approval. Quoin plans to begin a company-sponsored Phase 2/3 study for Peeling Skin Syndrome in the second half of 2026.
Is Quoin Pharmaceuticals publicly traded?
Yes, on the Nasdaq Capital Market under the ticker QNRX. It is a small, thinly traded biotech that disclosed going-concern doubts in its August 2026 quarterly filing before announcing a private placement of up to $50.0 million later that month.
