Mifomelatide_Dosage, benefits & legal status
Also known as TCMCB07, TCMCB-07
An experimental daily shot that switches off two appetite-suppressing receptors, the reverse of setmelanotide.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is Mifomelatide?
Plain language first. The technical label stays, but it never stands alone.Overview
Cancer and other illnesses push that brake on, so people stop eating and waste away, and blocking it is meant to bring appetite back and hold weight. A 76-person phase 1 found it tolerable, and a phase 2 in people starting chemotherapy for colorectal or pancreatic cancer began in April 2025. It is not approved anywhere.
Mifomelatide (TCMCB07) is a nine-residue cyclic peptide that blocks the MC3 and MC4 melanocortin receptors, the brain's main brake on appetite. Kenneth Gruber designed it at Tensive Controls (now Endevica Bio), with animal work at the University of Missouri and OHSU, and the 2026 spinout Kalohexis now leads it.
What it's used for
An experimental daily injection to stop weight loss during cancer chemotherapy. The animal data are strong; human efficacy results are not out yet.
How does Mifomelatide work?
What it does in the body, and where.Mifomelatide is a nine-residue peptide closed into a ring that sits in the MC3 and MC4 receptors without switching them on.
- 01The appetite brakeMelanocortin signalling in the hypothalamus suppresses feeding and growth. Cancer, kidney failure and inflammation turn that signal up, driving the appetite loss and wasting of cachexia.
- 02Blocking itIn rats with cancer, kidney failure or chemotherapy-induced anorexia, blocking these receptors raised food intake and kept fat on. Lean mass recovered in the kidney model but improved only slightly in the chemotherapy study.
- 03Reaching the brainMost peptides struggle to enter the brain. The developers infer that this one does from its effects after injection under the skin, and their patent shows transport data. Reported potency varies by assay: IC50 11 nM at MC3R and 31.5 nM at MC4R in the 2020 paper.
A schematic of the compound's mechanism, not a diagnostic image.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
In people so far
Investigational- human-earlyPhase 1 in 76 healthy volunteers: no drug-related serious adverse events; injection-site reactions were the most common side effect.
- No dataOver 5 days of dosing, the two higher multiple-dose cohorts gained 1.07 kg more than placebo. The study was not designed to test efficacy.
- No dataThe phase 2 in cancer patients is recruiting, with no results expected before late 2027.
Animal studies
Early research- Animal studyRats with cancer, kidney failure or inflammation ate more and kept fat on; in kidney failure, body weight returned to normal by day 14.
- Animal studyRats on chemotherapy kept their fat with four of six regimens, but lean-mass loss was not significantly reduced, and tumours did not grow faster.
- Animal studyPet dogs with cachexia gained about 0.9 kg on average in 4 weeks in an open-label study with no control group.
The phase 2 is not only for established cachexia: its colorectal cohort is newly diagnosed patients starting chemotherapy who have not yet lost 10% of their weight, so it tests prevention; only the pancreatic cohort requires cachexia. 'No treatment-related side effects' overstates phase 1: it reported no drug-related serious events, with injection-site reactions most common. The '1.1 kg over 5 days' figure is 1.07 kg across two cohorts in a study not built to test efficacy. Vendors call it orally active, but the only oral data come from one rat model and every human dose has been an injection. Lean-mass claims run ahead of the 2025 chemotherapy data. Do not confuse it with 710GO, the same company's appetite-reducing agonist.
The published record
Papers and trials about Mifomelatide
5 papers tagged human · 2 not reviews or lab · 0 clinical trial publications
3 registered trials · none with posted results
Furthest stage reached: Phase 2, under way
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about Mifomelatide
Evidence
Investigational
Category
Muscle building
Common vial
Varies
Half-life
Not published in people
How much, and do you cycle it?
The range, and whether you take breaks.12.5 to 50 mg daily (phase 2 doses), daily. Not cycled in the trials Trial dose
Given daily for 12 weeks alongside chemotherapy in the phase 2, with an optional 26-week extension. No planned breaks.
Not published in peopleTrial protocol
Phase 1 blood levels were higher than rat and dog data predicted, enough to lower one dose cohort, but no half-life was published. The developers' 2022 paper describes a half-life of hours in animals, against minutes for older peptides of this class.
Source: Qi LK et al., ASCO 2023 abstract e15195 (exposure reported, no half-life)
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Dry powder in the freezer or fridge. Once mixed, fridge, and use within about a month.
Unmixed lyophilized Mifomelatide keeps for a long time cold. Once you add water the clock starts: most reconstituted vials hold up for roughly 28 to 30 days at fridge temperature. Keep it out of light, and do not freeze it after mixing.
What are the side effects and cautions?
Known cautions and warnings for this compound.Solubility, computed: 56% charged residues, 67% hydrophobic. Water usually sufficient.
A first-pass rule from peptide manufacturers' guidance. It does not account for disulfide bridges, salt form or how the powder was dried, and it predicts what should be easy rather than what will happen in your vial.
Who should avoid it
- Brain or spinal cord metastases, excluded from the phase 2
- Significant heart disease: the phase 2 requires normal heart markers, and dog studies were monitored for slow heart rate and low blood pressure
- Daily steroids at 5 mg of prednisone or more, or other drugs that change appetite or weight
- A history of anorexia or bulimia, or past weight-loss surgery
- Pregnancy
Stop and get help
- Fainting, dizziness or a very slow pulse
- Spreading hives, swelling of the face or throat, or trouble breathing
- An injection site that becomes hot, very painful or starts spreading
Common effects
- Injection-site reactions, mostly grade 1 to 2, the most common study-related side effect in phase 1 (rates not published)
- No drug-related serious adverse events and no abnormal vital signs or ECGs in 76 healthy volunteers
- Coat darkening in dogs that reversed after stopping; skin darkening was not reported in the phase 1 abstract
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is Mifomelatide approved?
And where the numbers on this page come from.No. Mifomelatide is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.
- Approval statusInvestigational
- RouteUnder the skin (subcutaneous)
- Checked12 October 2026
- DoseFrom published clinical trials. Not approved by a regulator for this dose.
- Vial sizeFrom what vendors typically list; not a recommendation.
- SourcesFDA GSRS substance record, mifomelatide (UNII ZCH45RV64X)ClinicalTrials.gov, Paradox phase 2 (NCT06937177)ClinicalTrials.gov, phase 1 (NCT05529849)Qi LK et al., ASCO 2023 abstract e15195, phase 1 resultsZhu X et al., Journal of Clinical Investigation 2020;130:4921-4934Zhu X et al., Journal of Clinical Investigation 2025;135:e181305Axiak-Bechtel S et al., Journal of Veterinary Internal Medicine 2023US9534018B2, Melanocortin analogs having enhanced activity and transportEndevica Bio, spinout of Kalohexis (19 Mar 2026)
What has happened recently
Not approved anywhere. The FDA accepted the IND in June 2022. A 76-person phase 1 in healthy volunteers (NCT05529849) finished in February 2023. The phase 2 Paradox trial (NCT06937177) began on 28 April 2025 and aims to enrol up to 120 people with newly diagnosed colorectal or pancreatic cancer on chemotherapy, with primary completion expected in October 2027. ClinicalTrials.gov still names Endevica Bio as sponsor; Kalohexis, spun out in March 2026, now leads the programme. Mifomelatide is a proposed INN (WHO list 130); its recommended status was not confirmed. No orphan or fast track designation was found.
You can compare this against the whole library, or read how to check a seller.
What else is like Mifomelatide?
Others in Muscle building, side by side.If you're weighing Mifomelatide, it's worth reading Tesamorelin, Ipamorelin, and CJC-1295 no DAC (Mod GRF 1-29) in the same class.
An experimental daily shot that switches off two appetite-suppressing receptors, the reverse of setmelanotide.
- Dose
- 12.5 to 50 mg daily (phase 2 doses)
- How often
- Daily
An approved shot proven to shrink stubborn belly fat.
- Dose
- 1.28 up to 2 mg per day, depending on which product you have
- How often
- Daily
A gentle shot that nudges your body to release its own growth hormone.
- Dose
- 0.2 up to 0.3 mg per dose (start low, increase slowly)
- How often
- Daily, often at night
A short-acting growth-hormone pulse, usually paired with ipamorelin.
- Dose
- 0.1 mg per dose
- How often
- Daily to 2x daily
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- FDA GSRS substance record, mifomelatide (UNII ZCH45RV64X)(2026)Proposed INN (list 130), code TCMCB07, CAS 1456699-27-6. N-acetyl-norleucyl-Asp-Pro-D-2-naphthylalanyl-Arg-Trp-Lys-D-Val-D-prolinamide with a 2-to-7 lactam ring. C63H87N15O11, MW 1230.46.
- ClinicalTrials.gov, Paradox phase 2 (NCT06937177)(2026)Randomised, quadruple-masked; colorectal and pancreatic cancer cohorts on chemotherapy, each 1:1:1:1 to placebo or 12.5, 25 or 50 mg daily for 12 weeks. Up to 120 participants at 26 sites. Primary endpoints: weight change at 12 weeks and safety. Started 28 April 2025.
- ClinicalTrials.gov, phase 1 (NCT05529849)(2023)Single and multiple ascending doses in 76 healthy volunteers, once-daily subcutaneous injection against placebo. Completed February 2023; no results posted.
- Qi LK et al., ASCO 2023 abstract e15195, phase 1 results(2023)No abnormal vital signs or ECGs and no drug-related serious adverse events; injection-site reactions most common. Exposure higher than predicted from animals. Between-group weight difference 1.07 kg (p=0.0195) in two multiple-dose cohorts; not designed to test efficacy.
- Zhu X et al., Journal of Clinical Investigation 2020;130:4921-4934(2020)In rat models of cancer, kidney failure and inflammation, TCMCB07 raised food intake, preserved fat and, in kidney failure, restored body weight to sham level by day 14. MC3R IC50 11.1 nM, MC4R 31.5 nM.
- Zhu X et al., Journal of Clinical Investigation 2025;135:e181305(2024)In rats on six chemotherapy regimens, fat mass was fully retained with four of them; lean mass loss was not significantly reduced. No change in tumour growth. An anti-GDF15 antibody added to the effect.
- Axiak-Bechtel S et al., Journal of Veterinary Internal Medicine 2023(2023)Open-label, 14 client-owned dogs with cachexia, 4 weeks: mean weight 18.6 to 19.5 kg (P<.02), with better body and muscle condition scores. Coat pigmentation changed in 4 dogs; BUN rose.
- US9534018B2, Melanocortin analogs having enhanced activity and transport(2017)Inventor Gruber; assignee now Endevica Bio. Gives the TCMCB07 sequence and blood-brain barrier transport data after IV dosing.
- Endevica Bio, spinout of Kalohexis (19 Mar 2026)(2026)Mifomelatide becomes the cachexia lead of the new company Kalohexis; licence terms not disclosed.
Beyond these, 13 records are indexed. Browse the records