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 March 19, 2026

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

 Re: Clinuvel Pharmaceuticals Limited
 Amendment No. 1 to Draft Registrant Statement on Form 20-F
 Submitted March 4, 2026
 CIK No. 0001290877
Dear Phillipe Wolgen:

 We have reviewed your filing and have the following comments.

 Please respond to this letter within ten business days by providing the
requested
information or advise us as soon as possible when you will respond. If you do
not believe a
comment applies to your facts and circumstances, please tell us why in your
response.

 After reviewing your response to this letter, we may have additional
comments.

Amendment No. 1 to Draft Registrant Statement on Form 20-F
Item 3. Key Information
B. Capitalization and Indebtedness, page 4

1. We acknowledge your response to prior comment four. Please revise to
address the
 following:
 Revise the total capitalization amount in the table to reconcile to
the balance sheet
 rather than using market capitalization;
 Include a double line underneath the cash and cash equivalents and
short-term
 investments numbers to distinguish them from the capitalization line
items; and
 Explain what the 'All other assets' line item represents and why it
is included in the
 table.
Item 4. Information on the Company, page 22

2. We note that your January 12, 2026 press release announced a significant
expansion of
 your VALLAURIX Research, Development and Innovation (RD&I) Centre in
 March 19, 2026
Page 2

 Singapore. With reference to Items 4.D. and 10.C. of Form 20-F, please
revise to discuss
 this project and its impact or advise.
Item 4.B. Business Overview, page 24
Grow the Research and Development Capacities and Broaden Therapeutic Portfolio,
page 27

3. We note your response to prior comment 8, as well as the inclusion of
the pipeline table
 appearing on page 28. In this regard:
 We note that the row reflecting SCENESSE in adolescent EPP indicates
that the next
 anticipated program milestone is a "filing in H2 2026." Please revise
to clarify the
 relevant regulator or jurisdiction as appropriate.
 Revise the row reflecting SCENESSE in adolescent and adult vitiligo
to (1) clarify in
 a footnote or otherwise, that the ongoing Phase 3 CUV105 trial is
evaluating
 SCENESSE with adjunctive phototherapy and not as a monotherapy and
(2)
 to include the year in which you expect topline results from the
CUV105 trial.
 We note your disclosure on page 27 that you recently announced that
you are
 developing liquid injectable controlled-release doses for
melanocortin delivery, and
 that VLRX-L, the first of these platforms, entered a preclinical
study in early 2026;
 however it is not clear whether you have selected a targeted
indication for this
 program at this time. As it appears this program may be too
preliminary to be
 emphasized in the pipeline table at this time, please provide us with
your analysis
 supporting your determination to include it. If this program is
currently material,
 please revise the table to identify the targeted indication and/or
revise your
 disclosure as appropriate.
 Please remove the row reflecting "Other platforms TBA," as any such
platforms do
 not appear to be currently material enough to your business to
justify highlighting
 in the pipeline table.
 Please limit the pipeline table to depict only your material
pharmaceutical programs,
 and remove the row reflecting your PhotoCosmetics program. In this
regard, we note
 that the development of cosmetics is not subject to the same clinical
development
 and regulatory review process reflected by the table, and therefore,
the narrative
 disclosure is a more appropriate place to discuss the PhotoCosmetics
program.
4. We acknowledge your response to prior comment 11, which we reissue with
respect to
 the bullet points below. In this regard, we note that your pipeline
table should be a visual
 reflection of the narrative discussion in the prospectus, which
discussion should provide
 proper context and thoroughly address all completed, ongoing, and
planned preclinical
 and clinical trials of your material product candidates.
 The pipeline table, and your narrative disclosure on page 28
regarding the
 expected marketing submission for NEURACTHEL in the EU, suggests
that all
 clinical trials of NEURACTHEL for IS and MS are complete. However,
it does not
 appear that the design of these clinical trials, or the results
observed, are discussed.
 On page 28, you reference a prior CUV102 trial of SCENESSE in
adolescent and
 adult vitiligo; however, the trial phase, trial design, and results
observed do not
 appear to be discussed.
 Please revise or otherwise advise.
 March 19, 2026
Page 3

5. Please revise page 28 to disclose the jurisdiction(s) where you plan to
apply for
 regulatory approval for SCENESSE in adolescent and adult vitiligo and in
variegate
 porphyria, and, as appropriate, in which order.
SCENESSE, page 28

6. We note your statement that "[c]urrently, the largest market opportunity
is seen in
 vitiligo..." To provide insight into the size of the market opportunity,
please revise to
 discuss the estimated size of the vitiligo patient population in
adolescents and adults
 worldwide and/or in markets that are material to your business
prospects. Similarly, with
 respect to your late-stage NERUACTHEL program, provide the estimated
size of the
 patient population with infantile spasms and acute exacerbations of MS,
which you state
 you believe would benefit from NEURACTHEL treatment.
Item 5. Operating and Financial Review and Prospects
A. Operating Results
Research and Development, page 46

7. We acknowledge your response to prior comment 24 and partially reissue
our comment.
 Please revise to disclose the following:
 Whether you track your research and development costs by program
area; and
 As 'Other costs' is over 40% of 2025 research and development
expense, please
 revise to quantify and disclose its components and whether this
material trend is
 expected in future periods.
Table of Contents, page F-1

8. Please revise the table of contents to your Item 18 financial statements
to address the
 following:
 Revise to disclose the December 31, 2025 interim financial
statements and notes
 thereto; and
 Please distinguish that your interim financial statements are
unaudited and presented
 on an IFRS basis, as opposed to your annual financial statements
that are audited and
 presented on a U.S. GAAP basis.
Notes to the Consolidated Financial Statements
Note 2. Summary of Significant Accounting Policies
Revenue, page F-8

9. We acknowledge your response to prior comment 23 and partially reissue
our comment.
 Please revise your footnotes or MD&A to disclose the amounts for each
significant
 category of sales rebate and other variable consideration adjustment
reflected in the
 periods presented.
10. We note your disclosure on page 35 that changes in pricing of SCENESSE,
from
 which you have consistently generated over 90% of your product sales,
may have a
 severe impact on your operations, that you do not offer rebates or
discounts on
 SCENESSE beyond statutory requirements and that you aim for uniform
pricing per
 jurisdiction. As it appears that uniform pricing may coexist with
expected rebates and
 other variable consideration with EEA and U.S. national or private
insurers, whether
 March 19, 2026
Page 4

 stated or implicit, tell us how you considered whether any non-uniform
elements exist,
 and if so, whether they are variable consideration that should be
estimated and
 constrained in determining your transaction price under ASC 606. Please
provide us the
 accounting guidance that supports your determination.
Interim Condensed Financial Statements, page F-24

11. Please revise your December 31, 2025 interim financial statements to
include a header
 for each of the statements and notes that prominently include "IFRS" and
 "Unaudited" for immediate visibility to distinguish them from the U.S.
GAAP annual
 statements.
Notes to the Condensed Financial Statements, page F-28

12. Please revise the basis of presentation footnote to include that these
statements are
 prepared according to IFRS as issued by the IASB to qualify for the
reconciliation
 exemption under Instruction 4 of Item 8.A.5 of Form 20-F.
 We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.

 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 Hamill at 303-844-1008 or Joe McCann at 202-551-6262 with any
other
questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Louis Taubman
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