Thyroid eye disease treatment beyond the infusion: what the 2026 injection and tablet trials show, and what is not yet available
New treatment for thyroid eye disease in 2026: one injection awaits a regulator, one tablet has just entered its last trial stage, and one idea has failed. Here is what was actually reported, and what is not yet approved.
Consultant Ophthalmologist and Oculoplastic Surgeon · MMC 66025 · NSR 143681 · Consultations from early 2027
- As of 30 September 2026, neither the injection (satralizumab) nor the tablet (linsitinib) is approved for thyroid eye disease; the company says the US FDA decision on the injection is expected by 15 October 2026.
- In the two phase 3 satralizumab trials, a proptosis response at week 24 was 49.0% against 31.2% on placebo in one and 52.9% against 23.4% in the other, and only the second difference was statistically significant.
- The developer of the tablet, linsitinib, announced the first patients dosed in its phase 3 ORBIT trial in September 2026, and the registry estimates the primary results in mid 2028.
- An FcRn blocker, batoclimab, missed its main goal in both phase 3 trials, according to the company.
- Trial results are not head to head, so no source can rank these drugs, and established treatments still matter while you wait.
The question I expect from anyone with thyroid eye disease this autumn is a fair one: is anything coming that is not a drip? As of 30 September 2026 the honest answer is that one injection is waiting for a regulatory decision, one tablet has only just entered its final trial stage, and one promising idea has just missed its goal. None of the three is an approved treatment for thyroid eye disease today. This page sets out what has actually been reported, and I will update it once the regulator has decided.
Is there anything for thyroid eye disease beyond the infusion drugs?
Not yet as an approved option. The infusion drugs that block the IGF-1R receptor, a growth signal on cells behind the eye, are the ones already approved in the United States, and I cover them, including the hearing warning, in infusion treatment for thyroid eye disease: what to ask. I will not repeat that here.
What is being studied now falls into three groups. A subcutaneous injection, meaning a shot under the skin rather than into a vein, that blocks a different signal called interleukin-6. A tablet that blocks the same IGF-1R signal as the infusions. And a class of drugs called FcRn blockers, whose first phase 3 trials did not meet their goal. A trial is a test in volunteers, and a phase 3 trial is the large final test that regulators rely on. Please keep that distinction in mind as you read the numbers below: they describe what happened to trial volunteers, not what a treatment will do for you.
What is the new injection, and what did its trials show?
It is satralizumab, an antibody that blocks the interleukin-6 receptor, given as a subcutaneous injection. Interleukin-6 is one of the chemical messengers that drive inflammation, and that is the reason it was tried in thyroid eye disease. The results of the two phase 3 trials, SatraGO-1 and SatraGO-2, were published in the journal Ophthalmology on 7 September 2026.
Together the trials enrolled 258 adults, 131 and 127, who were randomly given either satralizumab or placebo, a dummy injection. In people with active disease, meaning red, swollen, inflamed tissue, the main measure was proptosis response, defined as the eye moving back by at least 2 mm at week 24. In SatraGO-1 that was 49.0% on the drug against 31.2% on placebo, and in SatraGO-2 it was 52.9% against 23.4%. Only the second difference was statistically significant, which means the first could plausibly be chance. The authors say so themselves: not all comparisons reached significance. Double vision improved by at least one grade in 44.4% against 34.4% in the first trial and 60.7% against 25.8% in the second, again significant only in the second.
The paper reports low rates of serious adverse events, treatment stops and infections, with no serious infections. Two things need saying. This is a 24-week result from a trial designed to run 72 weeks. And several authors are employees of the companies that make the drug, which is normal for a manufacturer's trial and worth knowing.
Is the injection approved yet?
No. The company, Roche, states that the US Food and Drug Administration has accepted its application under priority review and expects a decision by 15 October 2026. That is a company statement about a regulator's timetable, not a decision. A priority review means a faster review, and it is not an approval. I have found no source on whether it is registered or supplied in Malaysia, so I will say nothing about that.
The same drug is already approved elsewhere for a different, rare nerve condition, neuromyelitis optica spectrum disorder, according to the company. That gives doctors some experience with its safety, but it is a different disease and does not stand in for thyroid eye disease data. There is also no head-to-head trial against any infusion drug, so nobody can say from this evidence which is stronger.
Is there a tablet for thyroid eye disease?
Not yet, but one is in a phase 3 trial. Linsitinib is a small molecule taken by mouth that blocks the same IGF-1R receptor as the infusions. On 16 September 2026 its developer, Sling Therapeutics, announced that the first patients had been dosed in a phase 3 trial called ORBIT. The company describes the target as about 130 adults with moderate to severe active disease, half on linsitinib and half on placebo for 24 weeks.
The registry entry for ORBIT on ClinicalTrials.gov lists an estimated start in August 2026, recruitment in the United States, and an estimated primary completion in June 2028. That timeline matters: even if the trial succeeds, a tablet is some years from being a choice for anyone.
What do we know so far? The earlier phase 2b/3 trial enrolled 90 people, and its results are posted on the same registry. At week 24, 51.7% of those on the higher dose had a proptosis response, against 38.9% on the lower dose and 18.8% on placebo. Those are registry figures I read, not a peer-reviewed paper, and the group sizes were about 30 per arm. I would not assume that a tablet avoids the warnings attached to the infusion drugs, such as blood sugar and hearing. Only the larger trial can answer that. The company's statements that its safety is favourable are its own view.
What happened to the FcRn blockers?
Batoclimab, the FcRn blocker tested furthest so far, did not meet its goal. FcRn blockers are an immune-modulating class of drugs, first studied in Graves' disease, the thyroid condition behind most thyroid eye disease. Batoclimab was tested in two phase 3 trials in active thyroid eye disease, which the registry lists as enrolling 114 and 86 people. On 2 April 2026 the company reported that neither study met its primary endpoint, the same 2 mm proptosis measure at week 24, and that it would review its plans with its partner.
A review published this year adds that phase 3 trials of a second FcRn blocker, efgartigimod, were stopped early after an interim analysis suggested it was unlikely to reach its aim, while trials of others continue. A failed trial is useful. It tells doctors that this approach has not yet worked for the eye, and effort goes back to the signals that have.
Do these results apply to Asian patients?
Partly, and the honest answer is that we now have some Asian data but not for every drug. The SatraGO trials listed sites including Japan, Hong Kong, Singapore, China and South Korea. Separately, IBI311, an IGF-1R antibody with the same amino acid sequence as teprotumumab, was tested in 82 Chinese adults with active disease. At week 24 a proptosis response was seen in 85.8% on the drug and 3.8% on placebo, in a trial published in JAMA Ophthalmology in 2025. A Japanese trial of teprotumumab in 54 people, published in 2025, reported 89% against 11%.
A 2026 meta-analysis in the journal Drugs pooled seven trials of IGF-1R drugs, 669 patients, and found they outperformed placebo, with an average extra proptosis reduction of 2.22 mm. It also found more adverse events on treatment and recommended checks of blood sugar and hearing before and during treatment. One subgroup finding is worth noting: the double vision response differed between trials in mainly white and mainly East Asian populations, though the authors call this exploratory. Comparing the percentages between separate trials, as I have listed them, is not a valid way to rank drugs, because the volunteers and definitions differ.
What should I do while I wait for these?
Do not wait, because the established treatments still work for many people. The 2021 European guideline recommends intravenous steroid together with mycophenolate, an immune-calming tablet, as first-line treatment for active moderate-to-severe disease, and lists tocilizumab, another interleukin-6 blocker, among its second-line options. I explain what that means in thyroid eye disease and steroids. Stopping smoking is on the same guideline's list of measures for anyone who smokes.
If the eye has settled but remains pushed forward, that is a matter for surgery, not for a drug trial, and orbital decompression is the operation that makes room. To recognise the disease in the first place, start with bulging eyes, gritty vision and puffy lids. Optic neuropathy, damage to the optic nerve from crowding in the socket, is treated immediately according to the same guideline, so blurring or dimming of sight needs an eye doctor the same day.
These are the questions I would take to an endocrinologist and an ophthalmologist: which treatments for thyroid eye disease are registered here, is my disease active or inactive, would a clinical trial suit me, and what are the risks that apply to my own body? Thyroid eye disease is one of several reasons eyes can look different, and I place it among the others in what actually makes eyes look tired. The wider set of conditions is under orbit and thyroid eye disease.
- Your vision blurs or dims, which can mean the optic nerve is under pressure.
- You cannot close your eyes fully, or the surface of the eye is sore, dry or looks cloudy.
- You develop new double vision or a sudden change in how far the eyes protrude.
- You have thyroid eye disease and are considering an unregistered product or a trial: discuss it with your specialist first.
Questions patients ask
Approved options are still the established ones, and infusion drugs approved in the US. Newer candidates are a subcutaneous injection, satralizumab, awaiting an FDA decision expected by 15 October 2026 according to its maker, and a tablet, linsitinib, in phase 3. Neither is approved for thyroid eye disease as of 30 September 2026.
Satralizumab is an antibody that blocks the interleukin-6 receptor, a part of the inflammation signal. In the phase 3 trials it was given as a subcutaneous injection, under the skin, with loading doses at weeks 0, 2 and 4 and then every 4 weeks. It is not approved for thyroid eye disease as of 30 September 2026.
Partly. The main measure was a proptosis response of at least 2 mm at week 24 in active disease: 49.0% against 31.2% in SatraGO-1, not statistically significant, and 52.9% against 23.4% in SatraGO-2, significant. The authors state that not all comparisons reached significance.
Not yet. Linsitinib, a tablet that blocks the IGF-1R receptor, is in a phase 3 trial called ORBIT; its developer announced the first patients dosed in September 2026. Its registry entry estimates completion of the primary measure in June 2028, so it is not something to plan around.
The company reported that both batoclimab phase 3 trials missed their primary endpoint, and the release gives no reason. It said it would review plans with its partner. A separate review reports that trials of another FcRn blocker were stopped early for unlikely efficacy.
Yes, for some drugs. A Chinese trial of the IGF-1R antibody IBI311 in 82 adults and a Japanese trial of teprotumumab in 54 adults were both published in 2025, and the satralizumab trials had sites in several Asian countries. Results across separate trials cannot be ranked against one another.
No. The 2021 European guideline recommends intravenous steroid with mycophenolate as first-line for active moderate-to-severe disease, and stopping smoking is one of its measures. Sight-threatening disease needs urgent care. Ask your endocrinologist and ophthalmologist what is registered and suitable here.
Sources
- EUGOGO 2021 clinical practice guidelines for the medical management of Graves' orbitopathy (BOPSS-hosted PDF)
- Briceno et al: Efficacy and safety of satralizumab for thyroid eye disease, week 24 results from SatraGO-1 and SatraGO-2 (Ophthalmology, 2026)
- Zhang et al: IGF-1 receptor inhibitors for thyroid eye disease, systematic review and meta-analysis (Drugs, 2026)
- Roche media release: FDA priority review for satralizumab in thyroid eye disease, 30 June 2026 (company statement)
- Sling Therapeutics: first patients dosed in phase 3 ORBIT trial of linsitinib, 16 September 2026 (company statement)
- ClinicalTrials.gov: ORBIT phase 3 study of linsitinib, NCT07753603
- ClinicalTrials.gov: phase 2b/3 study of linsitinib, NCT05276063 (posted results)
- Immunovant: phase 3 batoclimab results in thyroid eye disease, 2 April 2026 (company statement)
- Zhang H et al: IBI311 for active thyroid eye disease in Chinese patients, RESTORE-1 randomised trial (JAMA Ophthalmology 2025;143:964-971)
- Hiromatsu Y et al: Teprotumumab for active thyroid eye disease in Japanese patients, randomised placebo-controlled trial (Lancet Regional Health Western Pacific 2025;55:101464)
- New horizons for autoimmune hyperthyroidism with FcRn blockers (Current Opinion in Endocrinology, Diabetes and Obesity, 2026)
General information written by a consultant oculoplastic surgeon. It does not replace an examination. If you are worried about your eyes or eyelids, please see an eye doctor. Written and reviewed by Dr Catherine Chow, Consultant Ophthalmologist and Oculoplastic Surgeon, MMC 66025 · NSR 143681.
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