The Appetite Pill Cancer Patients in Japan Have — and American Patients Still Don't

For most people with advanced cancer, the disease itself is only part of the fight. Up to 80% will develop cancer cachexia — a wasting syndrome marked by relentless muscle loss, appetite failure, and weight decline that chemotherapy alone cannot reverse. It saps strength, limits how much treatment a patient can tolerate, and is directly implicated in roughly one in five cancer deaths. For decades, doctors everywhere have watched it happen with no drug designed to treat it.

In Japan, that changed in December 2020. In the United States, it still hasn’t.

The drug: anamorelin

Anamorelin is an oral ghrelin receptor agonist — it mimics the body’s natural “hunger hormone,” stimulating appetite and helping raise insulin-like growth factor-1 levels associated with muscle preservation. Developed originally by Helsinn Group, it was studied in the large Phase 3 ROMANA 1 and ROMANA 2 trials in non-small cell lung cancer patients, where it produced measurable gains in body weight and lean body mass.

Where each country stands

Japan’s Ministry of Health, Labour and Welfare approved anamorelin (marketed as Adlumiz) on December 11, 2020, with manufacturing and marketing approval following in January 2021 from Ono Pharmaceutical. The approval covers cancer cachexia associated with four of the most common malignancies: non-small cell lung cancer, gastric cancer, pancreatic cancer, and colorectal cancer. Researchers writing in the Journal of Cachexia, Sarcopenia and Muscle described it plainly: Japan became the first country in the world to approve a drug specifically for this condition, and post-marketing surveillance since then has continued to track its real-world safety and effectiveness in Japanese patients.

The story took a different turn elsewhere. In May 2017, Europe’s medicines regulator, the CHMP, issued a negative opinion on the same drug, concluding the ROMANA trial data showed only a “marginal effect” on lean body mass with no proven benefit to hand-grip strength or quality of life — a decision upheld on re-examination that September. Anamorelin was never approved in Europe.

The United States never approved it either, and the gap it left behind has not been filled. As of 2026, there remains no FDA-approved pharmacological treatment for cancer cachexia — not anamorelin, not any alternative. American oncologists manage the condition with nutritional counseling, appetite stimulants approved for other conditions, and supportive care, but nothing built and approved for cachexia itself. The most advanced U.S. candidates, including Pfizer’s ponsegromab (targeting the GDF-15 pathway) and Endevica Bio’s TCMCB07, remain in clinical trials rather than in pharmacies.

Why this gap exists

The divergence isn’t a story of American medicine falling behind broadly — the U.S. remains a global leader in oncology drug development overall. It reflects a difference in how regulators weighed the same clinical data: Japan’s health ministry judged the ROMANA trial results sufficient given the size of the unmet need, while European and American regulatory pathways demanded a higher bar on functional outcomes like grip strength and quality of life before granting approval. Japan’s health system, with its emphasis on maintaining function and independence in aging patients, has also historically been quicker to adopt treatments aimed at quality of life during serious illness rather than survival alone.

The bigger picture

This kind of gap is exactly why comprehensive health assessment matters, especially for anyone managing a serious illness or simply wanting the clearest possible picture of their health. Japan’s broader medical culture — visible also in its nationwide Ningen Dock comprehensive screening programs — tends to prioritize catching decline early and treating it proactively, whether that decline is a tumor, a nutritional deficit, or the first signs of muscle wasting. For patients and families navigating cancer care, knowing that a treatment exists somewhere, even if it isn’t yet available at home, is worth understanding as part of the full range of options.

Sources: ONO Pharmaceutical: Manufacturing and Marketing Approval of Adlumiz, Wakabayashi et al., “The regulatory approval of anamorelin… in Japan: facts and numbers,” Journal of Cachexia, Sarcopenia and Muscle (PMC), EMA: Refusal of marketing authorisation for Adlumiz (anamorelin), ESMO: EMA Adopts a Negative Opinion for Anamorelin Hydrochloride, Pfizer: Pursuing the Next Breakthrough in Cancer Cachexia