Jawline Filler: The Two FDA-Approved Products, and What Their Trials Actually Found
Reviewed for medical accuracy against our Medical Review Board · Last updated 2 September 2026
Part of Dermal Fillers
Two products hold an FDA approval for the jawline. Not one, and not the dozen you will see advertised for it. Ask the FDA's device approval database for statements mentioning the jawline and it returns exactly two results. Ask it for the mandible and it returns none.
Both approvals are supplements carrying new clinical data, so each has a real randomised trial behind it. Read side by side, those two trials say something quite different from the marketing, and they disagree with each other in a way that is worth understanding before you spend anything.
The three things worth knowing before anything else. First, the two approved products are different chemistries, and only one of them can be dissolved if you dislike the result. Second, the two published success rates, 69.0% and 75.6%, cannot be compared: different measurement scale, different timepoint, and untreated control groups that scored 39.1% and 8.8%. Third, the median trial patient needed more than four syringes, so a "per syringe" price is a fraction of a jawline.
The two approved products, and the one that cannot be undone
Here is what the FDA has actually approved for this area, with the approval wording that matters.
| Product | FDA approval | Approved | Approved for |
|---|---|---|---|
| Radiesse (+) with lidocaine | P050052/S129 | 1 September 2021 | Deep injection for soft tissue augmentation to improve moderate to severe loss of jawline contour, adults over 21 |
| Juvéderm Volux XC | P110033/S065 | 29 July 2022 | Injection for improvement of jawline definition in adults over 21 with moderate to severe loss of jawline definition |
Both are limited to moderate to severe loss, and both to adults over 21. If your jawline change is mild, neither approval covers you, which does not make treatment wrong but does mean you are outside the studied population.
The difference that matters more is chemistry. Volux is hyaluronic acid. If you hate the result, or a vessel is compromised, hyaluronidase dissolves it. Radiesse is calcium hydroxylapatite, a mineral particle suspension, and hyaluronidase does nothing to it. There is no eraser. It softens as the body breaks it down over months, and until then what you have is what you have. We cover that at length on our Radiesse page.
So of the two products approved for your jawline, one is reversible and one is not. That single fact should probably drive a first-time decision more than any success rate, and it is almost never the thing a consultation leads with.
Why 69.0% and 75.6% are not a league table
Each trial reported a responder rate: the share of patients a blinded evaluator scored as at least one grade better on both sides of the jaw.
| Radiesse (+) | Volux XC | |
|---|---|---|
| Scale used | Merz Jawline Assessment Scale (MJAS), 5 points | Allergan Loss of Jawline Definition Scale (ALJDS), 5 points |
| Primary timepoint | Week 12 | Month 6 |
| Treated group | 75.6% (93/123) | 69.0% (108.3/157) |
| Untreated control | 8.8% (5/57) | 38.0% (18.6/49) |
| Randomisation | 123 treatment, 57 control | 157 treatment, 49 control (3:1) |
| Sites | 15 US sites | 19 sites |
Look at the control rows. Both groups received nothing at all, and were then photographed or examined by a blinded evaluator using that trial's scale. On the MJAS, 8.8% of untreated people were recorded as improved. On the ALJDS, 39.1% were, using the observed count at Month 6 (18/46).
That is a four-and-a-half-fold difference in how often "we did nothing" got written down as "this looks better". It is the cleanest available evidence that the two scales are not the same ruler, so comparing 75.6% against 69.0% tells you about the scales, not about the products.
What the numbers do support is that each product beat doing nothing in its own trial. Radiesse beat its control by 66.8 points (95% CI 53.7 to 75.2, p < 0.0001). Volux beat its control by about 31 points (p = 0.0001) and also cleared the pre-set bar of 50%. Both are real results. Neither is a ranking.
A note on that 108.3. Volux's primary figure is written as "69.0%, 108.3/157", and a count of 108.3 people is not a headcount. The analysis used multiple imputation to fill in missing data, which produces fractional counts. The plainly observed figure at the same visit was 69.9% (102/146). We quote both rather than picking the flattering one.
How much product a jawline actually took
This is the most useful number on the page, and the one no consumer page publishes.
| Product | Median at initial treatment | Range | Syringe size |
|---|---|---|---|
| Volux XC | 4.35 mL total | 1.0 to 9.3 mL | 1 mL |
| Radiesse (+) | 1.80 mL per side, so about 3.6 mL total | Not stated per side | 1.5 mL |
The median Volux patient in the trial received 4.35 mL at the first appointment, and some received 9.3 mL. Volux is sold in 1 mL syringes. So the typical studied treatment was more than four syringes, and the heaviest was nine.
Volux patients could also have a touch-up at one month, median 2.0 mL, and a maintenance treatment later, median 3.0 mL. Radiesse touch-ups ran a median 1.10 mL on the right and 1.25 mL on the left.
The practical consequence: when a clinic advertises jawline filler "from" a single syringe price, that price buys roughly a quarter of the treatment the trials tested. This is the question to settle at consultation, and it is a quantity question, not a price question. Ask how many millilitres your jaw is likely to need across the whole course.
How long it lasted, by each trial's own numbers
Both trials followed patients well past the primary endpoint, and both reported the decline honestly.
Volux XC tracked responder rates on the ALJDS at every visit after the initial or touch-up treatment. The treated group ran 78.7% at one month (118/150), 76.0% at three months (111/146), 69.9% at six (102/146), 64.9% at nine (87/134) and 61.3% at twelve (84/137). The control group, untreated, moved the other way: 22.7%, then 30.4%, then 39.1%, which is worth sitting with.
Radiesse (+) asked a narrower question. Among patients who had responded at Week 12, 76 of 113 (67.3%) still held that response at 48 weeks, assessed live by blinded evaluators, before any retreatment was offered.
Those two numbers are not interchangeable. Volux's 61.3% is the share of everyone with data at that visit. Radiesse's 67.3% is the share of responders only, so it excludes the people the treatment did not work for in the first place. A retention figure calculated among responders will always look better than one calculated among everybody.
The honest summary is that both products showed a real effect lasting about a year in most people who responded, with a steady decline rather than a cliff. For how that compares with neurotoxin timelines in the same region, see our page on masseter Botox for jaw slimming, which does a different job entirely.
Who was actually in these trials
Worth knowing, because jawline filler is marketed heavily to a group the trials barely contained.
| Radiesse (+), n=180 | Volux XC, n=157 treated | |
|---|---|---|
| Female | 81.1% (146/180) | 89.8% (141/157) |
| Male | 18.9% (34/180) | 10.2% (16/157) |
| Age | Mean 55.3, range 26 to 65 | Median 60, range 26 to 79 |
| White | 80.6% (145/180) | 84.1% (132/157) |
| Black or African American | 13.3% (24/180) | 13.4% (21/157) |
The median Volux patient was 60 years old. Radiesse's mean was 55.3, and its trial enrolled nobody over 65. These were studies of age-related loss of jaw definition, in predominantly white, predominantly female populations.
That is a long way from the audience being sold "jawline snatching" on social media. If you are in your twenties with a jaw you want sharper rather than restored, no trial here tested that, and the approval wording (moderate to severe loss) does not describe you. It can still be done. You are just not the studied case, and the durability numbers above may not transfer.
Both trials did report subgroup results, and they were reassuringly flat. Volux responders at six months ran 62.7% for Fitzpatrick I/II, 72.0% for III/IV and 80.0% for V/VI. Radiesse ran 71.4% for Fitzpatrick I to III and 82.6% for IV to VI. Neither trial found the treatment worked less well on darker skin.
Side effects, including two that only this area has
Injecting over a joint that moves every time you eat produces adverse events no other filler area reports.
In the Volux safety set of 198 patients, 16 (8.1%) had 20 treatment-related adverse events. The list includes mastication disorder in 2.0% (4/198), injection site nodule 1.5% (3/198), bruising 1.0% (2/198), and one case each (0.5%) of injection site hypersensitivity, mass, pain, temporomandibular joint syndrome, muscle tightness, muscle twitching and headache.
Mastication disorder means a problem with chewing. Together with the TMJ case, that is roughly one patient in forty reporting something about how their jaw worked, not just how it looked. This is the only facial filler region where that appears in the trial data at all, and it follows directly from where the product goes. No consumer page mentions it.
Radiesse's profile was the more front-loaded one. 42.3% (74/175) had at least one adverse event, with injection site mass in 10.9% (19/175), bruising 6.9% and pain 6.9%. Treatment-related events were almost all mild: 44 patients (25.1%) mild, one moderate, one severe.
The patient-diary numbers are the ones to actually plan around, because they capture the ordinary experience rather than the reportable one. After a first Radiesse treatment, of 175 patients:
| Response | None | Mild | Moderate | Severe |
|---|---|---|---|---|
| Swelling | 14.3% | 57.1% | 27.4% | 1.1% |
| Firmness | 23.4% | 58.9% | 17.1% | 0.6% |
| Lumps or bumps | 26.3% | 44.6% | 27.4% | 1.7% |
| Bruising | 34.3% | 40.0% | 24.6% | 1.1% |
| Redness | 60.6% | 32.6% | 6.9% | 0% |
Read the "none" column. Around 86% had some swelling, 77% some firmness and 74% felt lumps or bumps. Nearly half of all patients rated their worst reaction as moderate. These are expected treatment responses rather than complications, and they mostly settle within two weeks, but "you might have a little swelling" undersells them considerably.
Radiesse also logged seven adverse events starting 28 days or more after the last injection, including two nodules at 30 and 36 days lasting 100 and 38 days, and one product distribution issue at 59 days. Late nodules are the reason the irreversibility above matters. For the serious and rare end of the spectrum, including vascular events, read filler complications.
Needle or cannula, and the one cannula the label names
Both trials let injectors choose, and both reported the comparison.
Effectiveness barely moved. Radiesse responders were 77.8% (49/63) by cannula against 73.3% (44/60) by needle. Volux ran 73.5% (50/68) by cannula against 66.7% (52/78) by needle. Neither difference was statistically significant.
The experience differed more than the result did. In Radiesse's diaries, moderate bruising ran 28.4% with a needle against 20.7% with a cannula, while lumps or bumps ran higher with a cannula, 11.5% against 6.8%. Volux's treatment-related adverse event rate was 9.4% (10/106) with needles and 6.5% (6/92) with cannulas, a difference the FDA summary states was not statistically significant.
One specific detail worth carrying into a consultation: the Volux trial used a TSK STERiGLIDE 25 gauge, one and a half inch cannula, and the FDA summary states that this is the only cannula recommended for use with Volux. Needles used were 27 gauge, half inch. If an injector is using a cannula for Volux, that is the one the approval contemplates.
What "jawline filler" usually means in a clinic
Two products are approved here. Many more are used here, and that is legal, common, and not in itself a red flag. Off-label use of an approved filler is a clinical judgement a licensed injector is entitled to make.
What it does mean is that no regulator has reviewed a jawline dose, a jawline injection depth or a jawline safety profile for those products. When a clinic offers you a filler that is not Volux or Radiesse for your jaw, the honest description is that the product is approved, and this use of it is not studied. Ask which product, and ask whether it is being used inside its own approval.
There is also a genuine anatomical point behind the marketing. The Volux trial did not inject the jaw angle alone. Injections went into the prejowl sulci, the body of the mandible and postjowl sulci, the marionette lines, the chin, and the angle of the mandible. So the studied treatment was a whole lower face, chin included, not a line along the jaw. If your consultation is only about the jaw angle, you are discussing part of what was tested. Our chin filler page covers the overlapping region, and cheek filler covers the one above it.
What jawline filler costs
No manufacturer publishes a patient price for either product, and we do not publish figures we cannot source. What is reliable is how the area gets priced and what actually moves the number.
Jawline filler is sold by the syringe, and the volume data above is what makes that pricing misleading. At the trial median, Volux took 4.35 mL, which is more than four of its 1 mL syringes. Radiesse took about 3.6 mL, which is between two and three of its 1.5 mL syringes. So two clinics quoting the same per-syringe price can differ by a factor of two on the total, purely through product choice and how much they use.
From the verified prices we collect on our city pages, three things move injectable pricing more than the brand does: who injects, whether the quoted rate is a first-visit price, and whether a minimum spend applies. One Denver clinic publishes a 23 per cent premium for the physician over the nurse injector for the same product. In Chicago the lowest published rate we found rises 44 per cent on the second visit.
So the number to ask for is not the price of a syringe. It is the expected total millilitres across the initial treatment and any touch-up, at the price for the injector who will actually be treating you, on a return visit rather than a first one.
What to ask before you book
- Which product, and is my jawline inside its approval? Both approvals cover moderate to severe loss in adults over 21. Mild loss, or a jaw you want sharper rather than restored, is outside what was studied.
- Is it reversible? Volux dissolves with hyaluronidase. Radiesse does not. For a first treatment in a new area, that is a reasonable thing to want.
- How many millilitres in total, across the whole course? The trial medians were 4.35 mL for Volux and about 3.6 mL for Radiesse. A one-syringe quote is a partial treatment.
- Will the chin and prejowl area be treated too? The trials injected them. A jaw angle alone is a narrower treatment than the one the numbers come from.
- Needle or cannula, and which cannula? Results were similar either way. For Volux, the FDA summary names one recommended cannula.
- What happens if I get a nodule at six weeks? Radiesse's trial recorded nodules starting 30 and 36 days after injection. Ask what the plan is, and who pays for it.
- Who is injecting, and what is their rate? Physician and nurse-injector pricing differs measurably for identical product.
If you want the wider picture first, our dermal fillers guide covers what the FDA data shows across every approved filler, and filler recovery sets out what the first two weeks actually involve.
Frequently asked questions
How many fillers are FDA-approved for the jawline?
Is jawline filler reversible?
How many syringes does a jawline need?
Which is better, Volux or Radiesse?
How long does jawline filler last?
Can jawline filler affect chewing?
Is jawline filler suitable if I am in my twenties?
Does jawline filler work as well on darker skin?
Sources
Every figure on this page was read from the documents below rather than from a clinic or a manufacturer's marketing. They open in a new tab so you can check any claim here against its source.
- Summary of Safety and Effectiveness Data, P050052/S129, Radiesse (+) jawline contour, US Food and Drug Administration
- Summary of Safety and Effectiveness Data, P110033/S065, Juvéderm Volux XC jawline definition, US Food and Drug Administration
- Dermal fillers (soft tissue fillers), US Food and Drug Administration
- Dermal fillers, American Society of Plastic Surgeons
Know the count before the quote. The unit count is half the bill, and a low per-unit rate recovered by a high unit count is the commonest way a deal is not one. How to tell.
Deciding which area, not how many units? Botox by facial area covers what each zone actually achieves, which four are FDA approved, and the things Botox cannot fix at all.
