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 January 30, 2026

Phillipe Wolgen
Chief Executive Officer
Clinuvel Pharmaceuticals Limited
Level 22, 535 Bourke Street
Melbourne, VIC 3000
Australia

 Re: Clinuvel Pharmaceuticals Limited
 Draft Registration Statement on Form 20-F
 Submitted December 18, 2025
 CIK No. 0001290877
Dear Phillipe Wolgen:

 We have reviewed your draft registration statement and have the
following comments.

 Please respond to this letter by providing the requested information
and either submitting
an amended draft registration statement or publicly filing your registration
statement and non-
public draft submissions on EDGAR. If you do not believe a comment applies to
your facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing the information you provide in response to this letter
and your amended
draft registration statement or filed registration statement, we may have
additional comments.

Draft Registration Statement on Form 20-F submitted December 18, 2025
Item 3.B. Capitalization and Indebtedness, page 4

1. Please revise your statement of capitalization and indebtedness as of a
date no earlier
 than 60 days prior to the date of the registration statement. Refer to
Item 3.B of Form 20-
 F.
Item 3.D. Risk Factors, page 4

2. Please describe the risks related to your quorum requirements and voting
on a show of
 hands. Additionally, expand the disclosure on pages 18 and 65 to
describe the distinction
 between poll voting and voting on a show of hands. Disclose whether
proxies are
 counted in show of hands voting. If there are any circumstances in which
proxies are not
 counted, please explain those circumstances and expand your risk factor
discussion to
 describe the circumstances under which proxies will not be counted.
 January 30, 2026
Page 2

3. Based on your patent disclosures beginning on page 39, it appears that
certain patents in
 various jurisdictions related to the method for treatment of
photodermatoses will expire
 in 2027. As appropriate, please provide risk factor disclosure
discussing the extent to
 which you face material risk stemming from the expiration of these
patents, or otherwise
 advise.
Item 3. Key Information
B. Capitalization and Indebtedness, page 4

4. Please provide us with the calculation of total capitalization.
We rely on one manufacturer to synthesize the API in SCENESSE ..., page 7

5. We note that you rely on a sole contract manufacturer in China,
"Manufacturer A," to
 manufacture the API in SCENESSE in Manufacturer A s factory in
China. We also
 note your statement on page 15 that you expect to continue relying
solely on
 Manufacturer A in the next five years. In this regard:
 Please revise here and throughout where appropriate to identify
Manufacturer A.
 To the extent applicable, revise your Risk Factors where appropriate
to discuss the
 potential impact of the BIOSECURE Act, as included in the FY 2026
National
 Defense Authorization Act and singed into law on December 18, 2025,
on your
 operations, or otherwise advise.
ADS holders may not be entitled to a jury trial with respect to claims arising
under the deposit
agreement..., page 17

6. We note your disclosure that the deposit agreement governing the ADSs
representing
 your Ordinary Shares provides that, to the fullest extent permitted by
applicable law,
 owners and holders of ADSs irrevocably waive the right to a jury trial
for any claim that
 they may have against you or the depositary arising from or relating to
your Ordinary
 Shares, the ADSs, or the deposit agreement, including any claim under
the U.S. federal
 securities laws. Please revise this risk factor to also highlight risks
to investors including
 the potential for increased costs to bring a claim and the possibility
of less favorable
 outcomes.

Item 4.B. Business Overview, page 24

7. We refer to page F-16, which indicates that nearly all of your revenues
derive from
 product sales in Ireland and the United States, and your disclosure on
page 28 that
 Scenesse for EPP patients accounted for approximately 90% of your sales
in FY2025.
 Accordingly, please revise the Overview section to discuss the
concentration of sales in
 these two jurisdictions. Also, revise your Marketing and Sales section
to discuss your
 operations, as well as the coverage, pricing and reimbursement for
Scenesse, in these two
 jurisdictions.
8. Please tell us your consideration of including a pipeline table
depicting all material
 pharmaceutical candidate programs, the specific indications and patient
populations
 being pursued, and the status of development for each product candidate,
including
 separate columns of equal width for preclinical development, Phase 1,
Phase 2 and Phase
 January 30, 2026
Page 3

 3 clinical trials with arrows showing how far each program has
progressed. As
 applicable, consider a column indicating the next material milestone for
each program
 (e.g., submission of an IND or equivalent, timing of expected data from
ongoing trials,
 etc.).
9. We note your disclosure on page 28 that in addition to the current use
of SCENESSE
 for the treatment for adult EPP patients, you are (1) focused on
treating a wider group of
 EPP patients, most notably adolescent EPP patients, and (2) exploring
its use as a drug
 therapy in other indications such as vitiligo and variegate porphyria.
Additionally, we
 note that you are developing additional pharmaceutical products, such as
novel
 formulations of the melanocortin adrenocorticotropic hormone ( ACTH
) as
 NEURACTHEL in multiple dosage forms for patients with neurological,
 endocrinological, and degenerative disorders. With respect to each of
your development-
 stage programs, please:
 Revise your narrative disclosure to clearly disclose the development
status of each
 program/product candidate (i.e., preclinical or clinical-stage).
 With respect to each clinical-stage program/product candidate,
specifically state the
 applicable current clinical trial phase. For example only, revise
references
 throughout to your "advanced CUV105 clinical study" of SCENESSE for
the
 treatment of vitiglio to indicate the applicable clinical trial
phase.
10. With respect to each of your development-stage pharmaceutical product
candidates,
 please disclose the location(s) of completed, ongoing, and planned
clinical trials. As
 appropriate, disclose that clinical data generated in a jurisdiction
outside of the United
 States may not be accepted by the FDA or comparable foreign regulatory
authorities and
 if so, may result in the need to conduct additional trials.
Additionally, revise to include
 Risk Factor disclosure to this effect.
11. We note references here and elsewhere throughout to studies and clinical
trials of your
 product candidates, such as a recently completed pharmacokinetic study
in adolescent
 and adult EPP patients. We also note references on page 46 to "the
CUV104 Phase II
 pilot monotherapy vitiligo study and the CUV803 Phase II stroke study."
In your
 discussion of the preclinical and clinical development of your currently
material
 programs, please revise your disclosure to specify the following
information with respect
 to the preclinical studies and/or clinical trials that you have
conducted, are currently
 conducting, or plan to conduct:
 regulatory authorization(s) received or required to be received to
conduct the trial,
 and when such authorization(s) were received or will be sought;
 trial sponsor(s);
 dates of the trial and location;
 trial design;
 subject/patient information (e.g., number and age of
subjects/patients enrolled and
 treated and the criteria for participation in the study);
 duration of treatment and dosage information;
 primary and secondary endpoints, as well as any observed results as
they relate to
 those endpoints; and
 January 30, 2026
Page 4

 occurrence of serious adverse events, if applicable; and
 discussion of results, including whether statistical significance
was demonstrated and
 supporting p-values, as applicable.
12. You state on pages 24 and 28 that you are "developing and
commercializing novel
 formulations of the melanocortin adrenocorticotropic hormone ( ACTH
) as
 NEURACTHEL ..." Please remove or revise the present-tense reference to
 "commercializing," or otherwise advise. In this regard, we note that it
does not appear
 from your disclosure that you have received any regulatory approval for
 NEURACTHEL, which will seemingly be required prior to commercialization.
13. We note your disclosures on page 29 and 35 concerning your plans to
launch a number
 of non-pharmaceutical PhotoCosmetics products for the general population
based on
 melanocortin technology, including products to assist DNA repair and
melanocyte-
 stimulating hormone ( MSH )-response for assisting risk-free
bronzing "in the next few
 years." In this regard:
 Please revise where appropriate to describe the remaining material
steps, if any, that
 must be completed prior to fully launching your CYAC LLE products,
and when
 you plan for such steps to be completed, or otherwise advise.
 Briefly describe your various "PhotoCosmetic M-lines," including the
"Preserve"
 and "Bronze" product ranges referenced on page 46. Describe the
material steps you
 have taken to develop the products in each line, the material steps
that remain to be
 taken in order to commercially launch each line, and when you plan
such steps to be
 completed.
14. We note your disclosure on page 45 indicating that EPP is a rare
metabolic disorder. To
 provide insight into the size of the market opportunity, please revise
to discuss the
 estimated size of the EPP patient population worldwide and/or in markets
that are
 material to your business prospects.
Competitive Strengths, page 25

15. We note your references to Clinuvel's "rare and defensible advantage in
the orphan drug
 space" and to "orphan drug exclusivity" on page 25. In this regard,
please:
 Disclose whether SCENESSE received Orphan Drug designation for adult
patients
 with EDD, or otherwise advise. If so, disclose when such designation
was
 received, identify the regulator(s) that granted such designation,
and briefly describe
 the significance of having obtained Orphan Drug designation.
 Disclose the "certain regions" in which orphan drugs exclusivity
periods are still
 active, and state when such exclusivity will lapse. Make conforming
revisions to
 your Risk Factors, as appropriate.
Growth Strategy
Enhance the Distribution Network and Expand into New Geographic Markets, page
26

16. Please revise your disclosure on page 27 to indicate when you received
approval to
 commercially distribute SCENESSE in Australia and explain whether you
plan to
 start distribution in Australia in the near term. To the extent that you
have had this
 regulatory approval for an extended period, revise to explain the
decision to initiate
 January 30, 2026
Page 5

 distribution now. With respect to Australia, Colombia and Argentina,
discuss the key
 steps, if any, that must be completed in each jurisdiction prior to
commercialization.
Grow the Research and Development Capacities and Broaden Therapeutic Portfolio,
page 27

17. On pages 27 and 36, you state that Clinuvel "is developing" two
melanocortin-based
 pharmaceutical products: PR NUMBRA (afamelanotide) and NEURACTHEL
 (adrenocorticotropic hormone - ACTH). However, this disclosure seems to
conflict with
 your statement on page 28 that in November 2024, you "decided to
temporarily suspend
 further clinical development of PR NUMBRA to focus on the development
of
 afamelanotide for vitiligo and porphyrias, as well as the development of
ACTH and
 PhotoCosmetic product lines." Please revise throughout wherever
appropriate to clarify
 the current development status of PR NUMBRA or otherwise advise.

18. We note your disclosure that in September 2022, Clinuvel submitted a
formal application
 to the EMA to expand the approved EPP indication for SCENESSE to
include
 adolescent patients aged 12-17 years, but that application was withdrawn
"due to the
 EMA s opinion on the benefit-risk profile for adolescents." In this
regard, please:
 Please revise to briefly disclose the nature of the EMA's "opinion"
and describe any
 material feedback the EMA provided after the initial application
was submitted.
 You state that you are preparing a new submission with additional
data, including
 from a recently completed pharmacokinetic study in adolescent and
adult EPP
 patients. Please revise to disclose when you plan to submit the new
application to the
 EMA.
 Tell us your consideration of including Risk Factor disclosure
concerning the risks
 associated with drug development in pediatric populations, and/or
 regulatory disclosure discussing how the pediatric drug approval
process differs
 from the approval process in adult populations.
19. You state on page 27 that "[f]urther platform products liquid
injectable controlled-
 release doses for melanocortin delivery developed in CLINUVEL s
RD&I Centre in
 Singapore, have recently been announced." Please revise to disclose the
development
 status of these announced platform product candidates (i.e., preclinical
or clinical), and
 describe your near- and longer-term development plans for such
candidates.
NEURACTHEL , page 28

20. Please revise to expand your statement that you are "preparing
regulatory submissions to
 the U.S. FDA and other regulatory agencies." Explain the type(s) of
submission to which
 you refer, and explain when you plan to make such submissions.
Manufacturing and Logistics, page 32

21. Please revise to discuss the availability of raw materials, including a
description of
 whether prices of principal raw materials are volatile. Refer to Item
4.B.4 of Form 20-F.
 January 30, 2026
Page 6
Intellectual Property
Patents, page 39

22. Please revise your intellectual property disclosure to disclose for each
material patent
 and/or patent application the specific products or technologies to which
such patents or
 patent applications relate. Also clearly describe on an individual basis
the type of patent
 protection granted for each product or technology (composition of
matter, use, or
 process) and whether the patents are owned or licensed. For instance, it
should be clear
 when patent protections covering Scenesse will expire in the US and
Europe.
Item 5. Operating and Financial Review and Prospects
A. Operating Results
Revenue, page 45

23. We note your disclosure on page F-8 that revenue is reduced for variable
consideration
 when control of the product transfers. Please revise to disclose the
types and amounts of
 variable consideration and the significant judgments and estimates
involved in its
 measurement.
Research and Development, page 46

24. Please tell us whether you track your research and development costs by
program area. If
 so, revise to provide disaggregate disclosure of your research and
development expenses
 by program for each period presented. If not, revise to state that fact
and disclose other
 quantitative and qualitative disclosure that provides transparency as to
the types of costs
 incurred (i.e. preclinical and clinical and by nature or type of
expense) which should
 reconcile to total research and development expense on the Statements of
Operations.
C. Research and Development, Patents and Licenses, page 50

25. Please revise your disclosure for each of your pipeline candidates to
discuss each
 program's current phase of development, any prior material preclinical
or clinical studies
 and results, and any regulatory submissions made to date.

 Please contact Bonnie Baynes at 202-551-4924 or Vanessa Robertson at
202-551-3649 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Lauren Sprague Hamill at 303-844-1008 or Joe McCann at 202-551-6262
with any other
questions.

 Sincerely,

 Division of