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QTORIN rapamycin 3.9 percent gel

Microcystic lymphatic malformations

Regulatory submission
NDA submitted August 2026
Last updated
78 sources

Company-reported prevalence

QTORIN rapamycin 3.9 percent gel

Overview

FieldValue
DrugQTORIN rapamycin (3.9% rapamycin anhydrous gel)
IndicationMicrocystic lymphatic malformations
DiseaseMicrocystic lymphatic malformations (microcystic LMs); some figures count lymphatic malformations with cutaneous involvement
CompanyPalvella Therapeutics, Inc.; no licensing partner holding rights is named in the documents searched
Documents searchedPalvella website home, programs, and pipeline pages (undated, read October 2026); Palvella website publications and presentations page, including the Pediatric Dermatology Research Alliance 2024 poster and the ISSVA World Congress presentation of May 2026; press releases of February 21, 2023, March 9, 2023, November 16, 2023, April 23, 2025, January 9, 2026, February 24, 2026, March 2026 (full-year 2025 results), June 22, 2026, June 29, 2026, August 2026 (second-quarter results), August 31, 2026, September 28, 2026, and October 12, 2026; Form 10-K for 2025 (filed March 31, 2026); Form 10-Q for the second quarter of 2026; corporate presentation, September 2026
Data as ofOctober 14, 2026
Prepared byAI research agent (Claude); not yet reviewed by a person

Company statements of prevalence

United States

Number diagnosed: Palvella Form 10-K for 2025, March 2026

“It is estimated that there are more than 30,000 diagnosed patients in the United States with microcystic LMs.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Palvella Therapeutics (2026) Form 10-K for 2025, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Number diagnosed: Palvella corporate presentation, September 2026

“> 30k patients” (opens the source at this quote in a new tab)

“ESTIMATED DIAGNOSED IN THE U.S.” (opens the source at this quote in a new tab)

Cited source: 2.1 Society for Investigative Dermatology 2025; 2.2 Gallagher 2022

Palvella Therapeutics (2026) corporate presentation, September 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 15 of 67 (opens in a new tab)

Number affected: Palvella press release, September 2026

“QTORIN™ rapamycin has the potential to become the first FDA-approved therapy and establish a new standard of care for an estimated more than 30,000 pediatric and adult patients living with microcystic lymphatic malformations in the U.S.” (opens the source at this quote in a new tab)

Cited source: None stated in the document.

Palvella Therapeutics (2026) press release, September 28, 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Number diagnosed: Palvella ISSVA World Congress presentation, May 2026

“Microcystic LMs: Estimated U.S. diagnosed prevalence of ~45k-90k as presented at Society for Investigative Dermatology 2025 based on claims analysis” (opens the source at this quote in a new tab)

Cited source: 2.1 Society for Investigative Dermatology 2025; 2.3 Palvella Therapeutics 2025

Treat (2026) ISSVA World Congress presentation, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 5 of 14 (opens in a new tab)

Number diagnosed (lymphatic malformations with cutaneous involvement): Palvella press release, January 2026

“In May 2025, an abstract highlighting the estimated diagnosed prevalence and annual incidence of lymphatic malformation cases in the U.S. was presented at the 82nd Annual Meeting of the Society for Investigative Dermatology, indicating an estimated 44,553 to 92,967 diagnosed U.S. patients with lymphatic malformations with cutaneous involvement.” (opens the source at this quote in a new tab)

Cited source: 2.1 Society for Investigative Dermatology 2025

Palvella Therapeutics (2026) press release, January 9, 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Europe

No evidence found.

Global

No evidence found.

Other countries and regions

No evidence found.

Geography not stated

No evidence found.

Sources the company cites

Society for investigative dermatology 2025

Reference as the company lists it, corporate presentation, September 2026

“Incidence, prevalence, and care for patients with lymphatic malformations (LMs) in the U.S.: A claims-based analysis, Society of Investigative Dermatology, (2025)” (opens the source at this quote in a new tab)

“Includes microcystic LM and mixed LM” (opens the source at this quote in a new tab)

Palvella Therapeutics (2026) corporate presentation, September 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 15 of 67 (opens in a new tab)

Reference as the company lists it, ISSVA World Congress presentation

“presented at Society for Investigative Dermatology 2025 based on claims analysis” (opens the source at this quote in a new tab)

Treat (2026) ISSVA World Congress presentation, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 5 of 14 (opens in a new tab)

Reference as the company lists it, press release, January 9, 2026

“an abstract highlighting the estimated diagnosed prevalence and annual incidence of lymphatic malformation cases in the U.S. was presented at the 82nd Annual Meeting of the Society for Investigative Dermatology” (opens the source at this quote in a new tab)

Palvella Therapeutics (2026) press release, January 9, 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Passage carrying the figure

Not quoted: A poster presented at the Society for Investigative Dermatology annual meeting in May 2025; no published abstract or poster text was located.

Gallagher 2022

Reference as the company lists it

“Gallagher et al, Orphanet Journal of Rare Diseases, (2022).” (opens the source at this quote in a new tab)

Palvella Therapeutics (2026) corporate presentation, September 2026, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 15 of 67 (opens in a new tab)

Passage carrying the nearest figure

“Our survey results indicated the estimated number of unique annually managed LMC patients by target specialists is 79,920 (CI 66,600–93,250). This number corresponds to managed prevalence of 24.1 LMC patients per 100,000 population (CI 19.6/100,000–28.4/100,000).” (opens the source at this quote in a new tab)

“In our survey, we defined lymphatic malformations with a cutaneous component (LMC) as patients with either microcystic LM or mixed type LM.” (opens the source at this quote in a new tab)

Gallagher 2022, quoted passage highlighted (opens the full-size image in a new tab)
Captured from the passage on the page (opens in a new tab)

Palvella therapeutics 2025

Reference as the company lists it

“Palvella and ZS Associates claims analysis (2025).” (opens the source at this quote in a new tab)

Treat (2026) ISSVA World Congress presentation, quoted passage highlighted (opens the full-size image in a new tab)
Captured from page 5 of 14 (opens in a new tab)

Passage carrying the figure

Not quoted: A claims analysis by Palvella and ZS Associates that is not published as a document a reader can open.

References

  1. Gallagher 2022 (opens in a new tab)
  2. Palvella Therapeutics (2026) corporate presentation, September 2026 (opens in a new tab)
  3. Palvella Therapeutics (2026) Form 10-K for 2025 (opens in a new tab)
  4. Palvella Therapeutics (2026) press release, January 9, 2026 (opens in a new tab)
  5. Palvella Therapeutics (2026) press release, September 28, 2026 (opens in a new tab)
  6. Treat (2026) ISSVA World Congress presentation (opens in a new tab)